Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 26, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | OPGEN INC | ||
Entity Central Index Key | 1,293,818 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Public Float | $ 9,971,095 | ||
Trading Symbol | OPGN | ||
Entity Common Stock, Shares Outstanding | 8,645,720 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash and cash equivalents | $ 4,572,487 | $ 1,847,171 |
Accounts receivable, net | 373,858 | 809,540 |
Inventory, net | 543,747 | 533,425 |
Prepaid expenses and other current assets | 292,918 | 311,644 |
Total current assets | 5,783,010 | 3,501,780 |
Property and equipment, net | 1,221,827 | 835,537 |
Goodwill | 600,814 | 600,814 |
Intangible assets, net | 1,085,366 | 1,353,182 |
Other noncurrent assets | 259,346 | 328,601 |
Total assets | 8,950,363 | 6,619,914 |
Current liabilities | ||
Accounts payable | 1,623,751 | 1,691,712 |
Accrued compensation and benefits | 1,041,573 | 746,924 |
Accrued liabilities | 902,019 | 1,160,714 |
Deferred revenue | 15,824 | 24,442 |
Short-term notes payable | 398,595 | 1,010,961 |
Current maturities of long-term capital lease obligation | 399,345 | 154,839 |
Total current liabilities | 4,381,107 | 4,789,592 |
Deferred rent | 162,919 | 290,719 |
Note payable | 660,340 | 0 |
Warrant liability | 67 | 8,453 |
Long-term capital lease obligation and other noncurrent liabilities | 437,189 | 130,153 |
Total liabilities | 5,641,622 | 5,218,917 |
Commitments (Note 9) | ||
Stockholders' equity | ||
Common stock, $0.01 par value; 50,000,000 shares authorized; 8,645,720 and 2,265,320 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively | 86,457 | 22,653 |
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at December 31, 2018 and December 31, 2017, respectively | 0 | 0 |
Additional paid-in capital | 165,313,902 | 150,114,671 |
Accumulated other comprehensive loss | (13,093) | (25,900) |
Accumulated deficit | (162,078,525) | (148,710,427) |
Total stockholders’ equity | 3,308,741 | 1,400,997 |
Total liabilities and stockholders’ equity | $ 8,950,363 | $ 6,619,914 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 8,645,720 | 2,265,320 |
Common stock, shares outstanding | 8,645,720 | 2,265,320 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue | ||
Total revenue | $ 2,946,307 | $ 3,211,007 |
Operating expenses | ||
Research and development | 5,677,243 | 6,883,293 |
General and administrative | 7,069,315 | 6,692,659 |
Sales and marketing | 1,531,556 | 2,767,670 |
Total operating expenses | 16,126,549 | 18,476,798 |
Operating loss | (13,180,242) | (15,265,791) |
Other income/(expense) | ||
Interest and other income/(expense) | 5,384 | (87,255) |
Interest expense | (191,195) | (233,505) |
Foreign currency transaction (losses)/gains | (10,431) | 23,179 |
Change in fair value of derivative financial instruments | 8,386 | 144,064 |
Total other expense | (187,856) | (153,517) |
Loss before income taxes | (13,368,098) | (15,419,308) |
Provision for income taxes | 0 | 0 |
Net loss | $ (13,368,098) | $ (15,419,308) |
Net loss per common share - basic and diluted | $ (2.22) | $ (9.80) |
Weighted average shares outstanding - basic and diluted | 6,009,065 | 1,573,769 |
Net loss | $ (13,368,098) | $ (15,419,308) |
Other comprehensive income/(loss) - foreign currency translation | 12,807 | (32,076) |
Comprehensive loss | (13,355,291) | (15,451,384) |
Product [Member] | ||
Revenue | ||
Total revenue | 2,395,626 | 2,771,869 |
Operating expenses | ||
Cost of products and services | 1,222,919 | 1,612,838 |
Laboratory Service Revenue [Member] | ||
Revenue | ||
Total revenue | 34,665 | 41,960 |
Collaborations Revenue [Member] | ||
Revenue | ||
Total revenue | 516,016 | 397,178 |
Service [Member] | ||
Operating expenses | ||
Cost of products and services | $ 625,516 | $ 520,338 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Total | Public Offering [Member] | At the Market Offering [Member] | Common Stock [Member] | Common Stock [Member]Public Offering [Member] | Common Stock [Member]At the Market Offering [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member]Public Offering [Member] | Additional Paid-in Capital [Member]At the Market Offering [Member] | Accumulated Other Comprehensive (Loss) / Income [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2016 | $ 3,167,481 | $ 10,122 | $ 136,442,302 | $ 6,176 | $ (133,291,119) | ||||||
Balance (in shares) at Dec. 31, 2016 | 1,012,171 | ||||||||||
Stock option exercises | $ 8,180 | $ 12 | 8,168 | ||||||||
Stock option exercises (in shares) | 1,167 | 1,167 | |||||||||
Issuance of units, net of offering costs | $ 8,823,242 | $ 3,808,836 | $ 10,000 | $ 2,272 | $ 8,813,242 | $ 3,806,564 | |||||
Issuance of units, net of offering costs (in shares) | 1,000,000 | 227,216 | |||||||||
Issuance of RSUs | $ 60 | (60) | |||||||||
Issuance of RSUs (in shares) | 6,025 | ||||||||||
Stock compensation expense | $ 911,398 | 911,398 | |||||||||
Legal settlement in common stock | 109,999 | $ 158 | 109,841 | ||||||||
Legal settlement in common stock (in shares) | 15,843 | ||||||||||
Vendor payment in common stock | 23,245 | $ 29 | 23,216 | ||||||||
Vendor payment in common stock (in shares) | 2,898 | ||||||||||
Foreign currency translation | (32,076) | (32,076) | |||||||||
Net loss | (15,419,308) | (15,419,308) | |||||||||
Balance at Dec. 31, 2017 | $ 1,400,997 | $ 22,653 | 150,114,671 | (25,900) | (148,710,427) | ||||||
Balance (in shares) at Dec. 31, 2017 | 2,265,320 | ||||||||||
Stock option exercises (in shares) | 0 | ||||||||||
Issuance of units, net of offering costs | $ 13,530,401 | $ 597,743 | $ 59,123 | $ 3,182 | $ 13,471,278 | $ 594,561 | |||||
Issuance of units, net of offering costs (in shares) | 5,912,307 | 318,236 | |||||||||
Issuance of RSUs | $ 57 | (57) | |||||||||
Issuance of RSUs (in shares) | 5,650 | ||||||||||
Stock compensation expense | $ 862,281 | 862,281 | |||||||||
Share cancellation (in shares) | (31) | ||||||||||
Interest settlement in common stock | 272,610 | $ 1,442 | 271,168 | ||||||||
Interest settlement in common stock, (in shares) | 144,238 | ||||||||||
Foreign currency translation | 12,807 | 12,807 | |||||||||
Net loss | (13,368,098) | (13,368,098) | |||||||||
Balance at Dec. 31, 2018 | $ 3,308,741 | $ 86,457 | $ 165,313,902 | $ (13,093) | $ (162,078,525) | ||||||
Balance (in shares) at Dec. 31, 2018 | 8,645,720 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities | ||
Net loss | $ (13,368,098) | $ (15,419,308) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 730,884 | 669,088 |
Noncash interest expense | 133,802 | 185,294 |
Share-based compensation | 862,281 | 911,398 |
Gain on sale of equipment | (5,253) | 0 |
Change in fair value of warrant liabilities | (8,386) | (144,064) |
Unamortized discount on bridge loan at repayment | 0 | 85,932 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 432,814 | (260,471) |
Inventory | (11,273) | 161,027 |
Other assets | 486 | (315,688) |
Accounts payable | 89,493 | (563,357) |
Accrued compensation and other liabilities | 77,871 | 399,224 |
Deferred revenue | (8,618) | (12,955) |
Net cash used in operating activities | (11,073,997) | (14,303,880) |
Cash flows from investing activities | ||
Purchases of property and equipment | (147,767) | (276,950) |
Proceeds from sale of equipment | 10,440 | 0 |
Net cash used in investing activities | (137,327) | (276,950) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 597,743 | 3,808,836 |
Proceeds from issuance of units, net of selling costs | 13,530,401 | 8,754,882 |
Proceeds from debt, net of issuance costs | 381,253 | 1,168,222 |
Proceeds from exercise of stock options | 0 | 76,537 |
Payments on debt | (371,573) | (1,255,198) |
Payments on capital lease obligations | (292,722) | (205,085) |
Net cash provided by financing activities | 13,845,102 | 12,348,194 |
Effects of exchange rates on cash | 12,878 | (37,517) |
Net increase/(decrease) in cash, cash equivalents and restricted cash | 2,646,656 | (2,270,153) |
Cash, cash equivalents and restricted cash at beginning of year | 2,090,551 | 4,360,704 |
Cash, cash equivalents and restricted cash at end of year | 4,737,207 | 2,090,551 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 57,393 | 48,211 |
Supplemental disclosures of noncash investing and financing activities: | ||
Shares issued to settle obligations | 272,610 | 133,245 |
Property and equipment acquired through capital lease | 706,778 | 0 |
Conversion of accounts payable to capital lease | 156,775 | 0 |
Unpaid deferred offering costs | $ 0 | $ 48,398 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization | Note 1 - Organization OpGen, Inc. (“OpGen” or the “Company”) was incorporated in Delaware in 2001. References in this report to the “Company” include OpGen and its wholly-owned subsidiaries. The Company’s headquarters are in Gaithersburg, Maryland, and its principal operations are in Gaithersburg, Maryland. The Company also has operations in Woburn, Massachusetts, Copenhagen, Denmark, and Bogota, Colombia. The Company operates in one business segment. OpGen, Inc. is a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease. The Company is developing molecular information products and services for global healthcare settings, helping to guide clinicians with more rapid and actionable information about life threatening infections, improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. Its proprietary DNA tests and informatics address the rising threat of antibiotic resistance by helping physicians and other healthcare providers optimize care decisions for patients with acute infections. The Company’s molecular diagnostics and informatics products, product candidates and services combine its Acuitas molecular diagnostics and Acuitas Lighthouse informatics platform for use with its proprietary, curated MDRO knowledgebase. The Company is working to deliver products and services, some in development, to a global network of customers and partners. • The Company’s Acuitas molecular diagnostic tests provide rapid microbial identification and antibiotic resistance gene information. These products include its Acuitas antimicrobial resistance, or AMR, Gene Panel (Urine) test in development for patients at risk for complicated urinary tract infection, or cUTI, and its Acuitas AMR Gene Panel (Isolates) test in development for testing bacterial isolates, and its QuickFISH and PNA FISH FDA-cleared and CE-marked diagnostics used to rapidly detect pathogens in positive blood cultures. Each of the Acuitas AMR Gene Panel tests is available for sale for research use only, or RUO. • The Company’s Acuitas Lighthouse informatics systems are cloud-based HIPAA compliant informatics offerings that combine clinical lab test results with patient and hospital information to provide analytics and actionable insights to help manage MDROs in the hospital and patient care environment. Components of the informatics systems include the Acuitas Lighthouse Knowledgebase and the Acuitas Lighthouse Software. The Acuitas Lighthouse Knowledgebase is a relational database management system and a proprietary data warehouse of genomic data matched with antibiotic susceptibility information for bacterial pathogens. The Acuitas Lighthouse Software system includes the Acuitas Lighthouse Portal, a suite of web applications and dashboards, the Acuitas Lighthouse Prediction Engine, which is a data analysis software, and other supporting software components. The Acuitas Lighthouse Software can be customized and made specific to a healthcare facility or collaborator, such as a pharmaceutical company. The Acuitas Lighthouse Software is not distributed commercially for antibiotic resistance prediction and is not for use in diagnostic procedures. The Company’s operations are subject to certain risks and uncertainties. The risks include the risk that the Company will not receive 510(k) clearance for its Acuitas AMR Gene Panel tests and Acuitas Lighthouse Software on a timely basis, or at all, rapid technology changes, the need to retain key personnel, the need to protect intellectual property and the need to raise additional capital financing on terms acceptable to the Company. The Company’s success depends, in part, on its ability to develop, obtain regulatory approval for and commercialize its proprietary technology as well as raise additional capital. |
Going Concern and Management's
Going Concern and Management's Plans | 12 Months Ended |
Dec. 31, 2018 | |
Liquidation Basis Of Accounting Abstract [Abstract] | |
Going Concern and Management's Plans | Note 2 - Going Concern and Management’s Plans The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since inception, the Company has incurred, and continues to incur, significant losses from operations. The Company has funded its operations primarily through external investor financing arrangements and significant actions taken by the Company to reduce costs, including: • On October 22, 2018, the Company closed a public offering (the “October 2018 Public Offering”) of 2,220,000 shares of its common stock at a public offering price of $1.45 per share. The offering raised gross proceeds of approximately $3.2 million and net proceeds of approximately $2.8 million. • On June 11, 2018, the Company executed an Allonge (the “Allonge”) to its Second Amended and Restated Senior Secured Promissory Note, dated June 28, 2017, with a principal amount of $1,000,000 issued to Merck Global Health Innovation Fund, LLC (“MGHIF”). The Allonge provided that accrued and unpaid interest of $285,512 due as of July 14, 2018, the original maturity date, be paid through the issuance of shares of OpGen’s common stock in a private placement transaction. In addition, the Allonge revised and extended the maturity date for payment of the Note to six semi-annual payments of $166,667 plus accrued and unpaid interest beginning on January 2, 2019 and ending on July 1, 2021. On July 30, 2018, the Company issued 144,238 shares of common stock to MGHIF in a private placement transaction for $285,512 of accrued and unpaid interest due as of July 14, 2018 under the MGHIF Note. • On February 6, 2018, the Company closed a public offering (the “February 2018 Public Offering”) of 2,841,152 units at $3.25 per unit, and 851,155 pre-funded units at $3.24 per pre-funded unit, raising gross proceeds of approximately $12 million and net proceeds of approximately $10.7 million. Each unit included one share of common stock and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. As of April 19, 2018, all 851,155 pre-funded warrants issued in the February 2018 Public Offering have been exercised. • On July 18, 2017, the Company closed a public offering (the “July 2017 Public Offering”) of 18,164,195 units at $0.40 per unit, and 6,835,805 pre-funded units at $0.39 per pre-funded unit, raising gross proceeds of approximately $10 million and net proceeds of approximately $8.8 million. jVen Capital, LLC (“jVen Capital”) was one of the investors participating in the offering. jVen Capital is an affiliate of Evan Jones, the Company’s Chairman of the Board and Chief Executive Officer. Each unit included one twenty-fifth of a share of common stock and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. Each pre-funded unit included one pre-funded warrant to purchase one twenty-fifth of a share of common stock for an exercise price of $0.25 per share, and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. Approximately $1 million of the gross proceeds was used to repay the outstanding Bridge Financing Notes to jVen Capital in July 2017. • In early June 2017, the Company commenced a restructuring of its operations to improve efficiency and reduce its cost structure. Under the restructuring plan the Company is consolidating its operations, including manufacturing, for its FDA-cleared and CE marked QuickFISH and PNA FISH families of products and research and development activities for the Acuitas AMR Gene Panel products and services, in Gaithersburg, Maryland, and reducing the size of its commercial organization while the Company works to complete the development of its Acuitas AMR Gene Panel and Acuitas Lighthouse Knowledgebase products and services in development. • On May 31, 2017, the Company entered into a Note Purchase Agreement with jVen Capital, under which jVen Capital agreed to provide bridge financing in an aggregate principal amount of up to $1,500,000 to the Company in up to three separate tranches of $500,000 (each, a “Bridge Financing Note” and collectively, the “Bridge Financing Notes”). In connection with the issuance of Bridge Financing Notes, in June and July 2017, the Company issued jVen Capital stock purchase warrants to acquire 5,634 shares with an exercise price of $19.50 per share, and warrants to acquire 6,350 shares with an exercise price of $17.25 per share. The Company drew down on two of three Bridge Financing Notes during June and July 2017, and repaid such outstanding Bridge Financing Notes in full upon the closing of the July 2017 Public Offering. • On September 13, 2016, the Company entered into the Sales Agreement (the “Sales Agreement”) with Cowen and Company LLC (“Cowen”) pursuant to which the Company may offer and sell from time to time, up to an aggregate of $25 million of shares of its common stock through Cowen, as sales agent, with initial sales limited to an aggregate of $11.5 million. As of December 31, 2018, the Company sold an aggregate of 690,247 shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $8.8 million, and gross proceeds of $9.4 million. During the year ended December 31, 2018, the Company has sold 318,236 shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $0.6 million, and gross proceeds of $0.6 million. In connection with the October 2018 Public Offering, the Company terminated the at the market offering. To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, strategic financings or other transactions, additional equity financings, debt financings and other funding transactions, licensing and/or partnering arrangements and business combination transactions. There can be no assurance that the Company will be able to complete any such transaction on acceptable terms or otherwise. The Company believes that current cash will be sufficient to fund operations into the second quarter of 2019. This has led management to conclude that substantial doubt about the Company’s ability to continue as a going concern exists. In the event the Company is unable to successfully raise additional capital during or before the second quarter of 2019, the Company will not have sufficient cash flows and liquidity to finance its business operations as currently contemplated. Accordingly, in such circumstances the Company would be compelled to immediately reduce general and administrative expenses and delay research and development projects, including the purchase of scientific equipment and supplies, until it is able to obtain sufficient financing. If such sufficient financing is not received on a timely basis, the Company would then need to pursue a plan to license or sell its assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy protection. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 3 - Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The consolidated financial statements consolidate the operations of all controlled subsidiaries; all intercompany activity is eliminated. Foreign Currency The Company has subsidiaries located in Copenhagen, Denmark, and Bogota, Colombia, both of which use currencies other than the U.S. dollar as their functional currency. As a result, all assets and liabilities are translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailing during the reporting period. Translation adjustments are reported in accumulated other comprehensive (loss)/income, a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive (loss)/income at December 31, 2018 and 2017. Foreign currency transaction gains and losses, excluding gains and losses on intercompany balances where there is no current intent to settle such amounts in the foreseeable future, are included in the determination of net loss. Unless otherwise noted, all references to “$” or “dollar” refer to the United States dollar. Use of Estimates In preparing financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying consolidated financial statements, estimates are used for, but not limited to, liquidity assumptions, revenue recognition, share-based compensation, allowances for doubtful accounts and inventory obsolescence, and valuation of derivative financial instruments measured at fair value on a recurring basis, deferred tax assets and liabilities and related valuation allowance, depreciation and amortization and estimated useful lives of long-lived assets. Actual results could differ from those estimates. Fair value of financial instruments Financial instruments classified as current assets and liabilities (including cash and cash equivalent, receivables, accounts payable, deferred revenue and short-term notes) are carried at cost, which approximates fair value, because of the short-term maturities of those instruments. For additional fair value disclosures, see Note 12. Cash and cash equivalents and restricted cash The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the federal government agency (FDIC) insured limits of $250,000. The Company has not experienced any losses in such accounts, and management believes it is not exposed to any significant credit risk. As of December 31, 2018 and 2017, the Company had funds totaling $164,720 and $243,380, respectively, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. These funds are reflected in other noncurrent assets on the accompanying consolidated balance sheets. Accounts Receivable The Company’s accounts receivable result from revenues earned but not collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 to 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $18,332 and $31,278 as of December 31, 2018 and 2017, respectively. At December 31, 2018, the Company had accounts receivable from one customer which individually represented 12% of total accounts receivable. At December 31, 2017, the Company had accounts receivable from one customer which individually represented 41% of total accounts receivable. For the year ended December 31, 2018, revenue earned from one customer represented 17% of total revenues. For the year ended December 31, 2017, revenue earned from one customer represented 11% of total revenues. Inventory Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following: December 31, 2018 2017 Raw materials and supplies $ 368,438 $ 360,134 Work-in process 58,402 51,233 Finished goods 116,907 122,058 Total $ 543,747 $ 533,425 Inventory includes reagents and components for QuickFISH and PNA FISH kit products, and reagents and supplies used for the Company’s laboratory services. Inventory reserves for obsolescence and expirations were $71,270 and $155,507 at December 31, 2018 and 2017, respectively. Long-lived assets Property and equipment Property and equipment is stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets. The estimated service lives approximate three to five years. Depreciation expense was $463,068 and $401,272 for the years ended December 31, 2018 and 2017, respectively. Property and equipment consisted of the following at December 31, 2018 and 2017: December 31, 2018 2017 Laboratory and manufacturing equipment $ 4,829,323 $ 4,109,367 Office furniture and equipment 700,299 700,299 Computers and network equipment 1,520,713 1,505,651 Leasehold improvements 745,800 729,504 7,796,135 7,044,821 Less accumulated depreciation (6,574,308 ) (6,209,284 ) Property and equipment, net $ 1,221,827 $ 835,537 Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the years ended December 31, 2018 and 2017, the Company determined that its property and equipment was not impaired. Intangible assets and goodwill Intangible assets and goodwill as of December 31, 2018 and 2017 were acquired as part of a July 2015 merger transaction in which the Company acquired AdvanDx, Inc. and its subsidiary (the “Merger”) Finite-lived intangible assets Finite-lived intangible assets include trademarks, developed technology and customer relationships, and consisted of the following as of December 31, 2018 and 2017: December 31, 2018 December 31, 2017 Cost Accumulated Amortization Net Balance Accumulated Amortization Net Balance Trademarks and tradenames $ 461,000 $ (159,783 ) $ 301,217 $ (113,679 ) $ 347,321 Developed technology 458,000 (226,746 ) 231,254 (161,322 ) 296,678 Customer relationships 1,094,000 (541,105 ) 552,895 (384,817 ) 709,183 $ 2,013,000 $ (927,634 ) $ 1,085,366 $ (659,818 ) $ 1,353,182 Finite-lived intangible assets are amortized over their estimated useful lives. The estimated useful life of trademarks is 10 years, developed technology is 7 years, and customer relationships is 7 years. The Company reviews the useful lives of intangible assets when events or changes in circumstances occur which may potentially impact the estimated useful life of the intangible assets. Total amortization expense of intangible assets was $267,816 and $267,816 for the years ended December 31, 2018 and 2017, respectively. Expected amortization of intangible assets for each of the next five fiscal years is as follows Year Ending December 31, 2019 $ 267,816 2020 267,816 2021 267,816 2022 165,117 2023 46,104 Thereafter 70,697 Total $ 1,085,366 Finite-lived intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i.e., the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. During the years ended December 31, 2018 and 2017, the Company determined that its finite-lived intangible assets were not impaired. In accordance with ASC 360-10, the Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that long-lived assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets. During 2018, events and circumstances indicated the Company’s intangible assets might be impaired. However, management’s estimate of undiscounted cash flows indicated that such carrying amounts were expected to be recovered. Nonetheless, it is reasonably possible that the estimate of undiscounted cash flows may change in the near term, resulting in the need to write down those assets to fair value. Goodwill Goodwill represents the excess of the purchase price for AdvanDx, Inc. and subsidiary (collectively, “AdvanDx”) over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions. The Company conducts an impairment test of goodwill on an annual basis as of October 1 of each year, and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value. As of December 31, 2018, the Company determined that its goodwill was not impaired. Deferred rent Deferred rent is recorded and amortized to the extent the total minimum rental payments allocated to the current period on a straight-line basis exceed or are less than the cash payments required. Revenue recognition Subsequent to the Adoption of Accounting Standards Codification Revenue from Contracts with Customers (“ASC 606”) on January 1, 2018 The Company derives revenues from (i) the sale of QuickFISH and PNA FISH diagnostic test products and Acuitas AMR Gene Panel (RUO) test products, (ii) providing laboratory services, and (iii) providing collaboration services including funded software arrangements, and license arrangements. The Company analyzes contracts to determine the appropriate revenue recognition using the following steps: (i) identification of contracts with customers, (ii) identification of distinct performance obligations in the contract, (iii) determination of contract transaction price, (iv) allocation of contract transaction price to the performance obligations and (v) determination of revenue recognition based on timing of satisfaction of the performance obligation. The Company recognizes revenues upon the satisfaction of its performance obligation (upon transfer of control of promised goods or services to our customers) in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services. The Company defers incremental costs of obtaining a customer contract and amortizes the deferred costs over the period that the goods and services are transferred to the customer. The Company had no material incremental costs to obtain customer contracts in any period presented. Deferred revenue results from amounts billed in advance to customers or cash received from customers in advance of services being provided. For details about the Company’s revenue recognition policy prior to the adoption of ASC 606, refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2017. Research and development costs Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and related expenses for personnel, other resources, laboratory supplies, fees paid to consultants and outside service partners. Share-based compensation Share-based compensation expense is recognized at fair value. The fair value of share-based compensation to employees and directors is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. A discussion of management’s methodology for developing each of the assumptions used in the Black-Scholes model is as follows: Fair value of common stock For periods prior to the Company’s IPO in May 2015, given the lack of an active public market for the common stock, the Company’s board of directors determined the fair value of the common stock. In the absence of a public market, and as an emerging company with no significant revenues, the Company believed that it was appropriate to consider a range of factors to determine the fair market value of the common stock at each grant date. The factors included: (1) the achievement of clinical and operational milestones by the Company; (2) the status of strategic relationships with collaborators; (3) the significant risks associated with the Company’s stage of development; (4) capital market conditions for life science and medical diagnostic companies, particularly similarly situated, privately held, early stage companies; (5) the Company’s available cash, financial condition and results of operations; (6) the most recent sales of the Company’s preferred stock; and (7) the preferential rights of the outstanding preferred stock. Since the IPO, the Company uses the quoted market price of its common stock as its fair value. Expected volatility Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Until a significant trading history for its common stock develops, the Company has identified several public entities of similar size, complexity and stage of development; accordingly, historical volatility has been calculated using the volatility of this peer group. Expected dividend yield The Company has never declared or paid dividends on its common stock and has no plans to do so in the foreseeable future. Risk-free interest rate This is the U.S. Treasury rate for the day of each option grant during the year, having a term that most closely resembles the expected term of the option. Expected term This is the period of time that the options granted are expected to remain unexercised. Options granted have a maximum term of 10 years. The Company estimates the expected term of the option to be 6.25 years for options with a standard four-year vesting period, using the simplified method. Over time, management will track actual terms of the options and adjust their estimate accordingly so that estimates will approximate actual behavior for similar options. Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized. Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority, assuming full knowledge of the position and all relevant facts. The Company had federal net operating loss (“NOL”) carryforwards of $178,163,456 and $165,981,195 at December 31, 2018 and 2017, respectively. Despite the NOL carryforwards, which begin to expire in 2022, the Company may have future tax liability due to alternative minimum tax or state tax requirements. Also, use of the NOL carryforwards may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”). To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Code. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized. Loss per share Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) stock purchase warrants, and (iii) restricted stock units representing the right to acquire shares of common stock which have been excluded from the computation of diluted loss per share, was 3.7 million shares and 1.6 million shares as of December 31, 2018 and 2017, respectively Adopted accounting pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) and International Accounting Standards Board (“IASB”) jointly issued a new revenue recognition standard, Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers On January 1, 2018, the Company adopted ASC 606, using the modified retrospective method. Results for reporting periods beginning subsequent to December 31, 2017 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with the Company’s historical accounting policies prior to adoption. In adopting the guidance, the Company applied the guidance to all contracts and used available practical expedients including assessing contracts with similar terms and conditions on a “portfolio” basis. The adoption of this new guidance did not have a material impact on the Company’s condensed consolidated financial statements. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows: Restricted Cash The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the statements of cash flows: December 31, 2018 December 31, 2017 December 31, 2016 Cash and cash equivalents $ 4,572,487 $ 1,847,171 $ 4,117,324 Restricted cash 164,720 243,380 243,380 Total cash, cash equivalents and restricted cash in the consolidated statements of cash flows $ 4,737,207 $ 2,090,551 $ 4,360,704 Accounting pronouncements not yet adopted In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) Leases (Topic 842) Targeted Improvements The new standard provides a number of optional practical expedients in transition. The Company expects to elect: (1) the ‘package of practical expedients’, which permits it not to reassess under the new standard its prior conclusions about lease identification, lease classification, and initial direct costs; (2) the use-of-hindsight; and (3) the practical expedient pertaining to land easements. In addition, the new standard provides practical expedients for an entity’s ongoing accounting that the Company anticipates making, such as the (1) the election for certain classes of underlying asset to not separate non-lease components from lease components and (2) the election for short-term lease recognition exemption for all leases that qualify. The Company will adopt ASC 842 as of January 1, 2019, using the alternative modified transition method. In preparation of adopting ASC 842, the Company is implementing additional internal controls to enable future preparation of financial information in accordance with ASC 842. The Company has also substantially completed its evaluation of the impact on the Company’s lease portfolio. The Company believes the largest impact will be on the consolidated balance sheets for the accounting of facilities-related leases, which represents a majority of its operating leases it has entered into as a lessee. These leases will be recognized under the new standard as ROU assets and operating lease liabilities. The Company will also be required to provide expanded disclosures for its leasing arrangements. As of December 31, 2018, the Company had $2.8 million of undiscounted future minimum operating lease commitments that are not recognized on its consolidated balance sheets as determined under the current standard. For a lessor, the results of operations are not expected to significantly change after adoption of the new standard. While substantially complete, the Company is still in the process of finalizing its evaluation of the effect of ASC 842 on the Company’s consolidated financial statements and disclosures. The Company will finalize its accounting assessment and quantitative impact of the adoption during the first quarter of fiscal year 2019. As the Company completes its evaluation of this new standard, new information may arise that could change the Company’s current understanding of the impact to leases. Additionally, the Company will continue to monitor industry activities and any additional guidance provided by regulators, standards setters, or the accounting profession, and adjust the Company’s assessment and implementation plans accordingly. In June 2018, the FASB issued ASU 2018-07: Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows. |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 12 Months Ended |
Dec. 31, 2018 | |
Revenue From Contract With Customer [Abstract] | |
Revenue from Contracts with Customers | Note 4 - Revenue from Contracts with Customers Disaggregated Revenue The Company provides diagnostic test products, laboratory services to hospitals, clinical laboratories and other healthcare provider customers, and enters into collaboration agreements with government agencies and healthcare providers December 31, 2018 2017 Product sales $ 2,395,626 $ 2,771,869 Laboratory services 34,665 41,960 Collaboration revenue 516,016 397,178 Total revenue $ 2,946,307 $ 3,211,007 Deferred Revenue Changes in deferred revenue for the period were as follows: Balance at December 31, 2017 $ 24,442 Revenue recognized in the current period from the amounts in the beginning balance (14,450 ) New deferrals, net of amounts recognized in the current period 5,832 Balance at December 31, 2018 $ 15,824 Contract Assets The Company had no contract assets as of December 31, 2018, which are generated when contractual billing schedules differ from revenue recognition timing. Contract assets represent a conditional right to consideration for satisfied performance obligations that becomes a billed receivable when the conditions are satisfied. Unsatisfied Performance Obligations The Company had no unsatisfied performance obligations related to its contracts with customers at December 31, 2018. |
MGHIF Financing
MGHIF Financing | 12 Months Ended |
Dec. 31, 2018 | |
Common Stock And Note Purchase Agreement [Abstract] | |
MGHIF Financing | Note 5 - MGHIF Financing In July 2015, in connection with the Merger, the Company entered into a Purchase Agreement with MGHIF, pursuant to which MGHIF purchased 45,454 shares of common stock of the Company at $110.00 per share for gross proceeds of $5.0 million. Pursuant to the Purchase Agreement, the Company also issued to MGHIF an 8% Senior Secured Promissory Note (the “MGHIF Note”) in the principal amount of $1.0 million with a two-year maturity date from the date of issuance. Also in July 2015, the Company entered into a Registration Rights Agreement with MGHIF and certain stockholders, which will require the Company to register for resale by such holders in the future, such shares of Company common stock that cannot be sold under an exemption from such registration. The Company’s obligations under the MGHIF Note are secured by a lien on all of the Company’s assets. On June 28, 2017, the MGHIF Note was amended and restated, and the maturity date of the MGHIF Note was extended by one year to July 14, 2018. As consideration for the agreement to extend the maturity date, the Company issued an amended and restated secured promissory note to MGHIF that (1) increased the interest rate to ten percent (10%) per annum and (2) provided for the issuance of common stock warrants to purchase 13,120 shares of its common stock to MGHIF. On June 11, 2018, the Company executed an Allonge to the MGHIF Note. The Allonge provided that accrued and unpaid interest of $285,512 due as of July 14, 2018, the original maturity date, be paid through the issuance of shares of OpGen’s common stock in a private placement transaction. In addition, the Allonge revised and extended the maturity date for payment of the Note to six semi-annual payments of $166,667 plus accrued and unpaid interest beginning on January 2, 2019 and ending on July 1, 2021. On July 30, 2018, the The Allonge to the MGHIF Note was treated as a debt modification and as such the unamortized issuance costs of approximately $7,000 as of June 11, 2018 is deferred and amortized as incremental expense over the term of the MGHIF Note. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Debt | Note 6 - Debt As of December 31, 2018, the Company’s outstanding short-term debt consisted of approximately $333,000 due under the MGHIF Note, as well as, the f with a final payment scheduled for April 2019. The Company’s outstanding long-term debt as of December 31, 2018 consisted of approximately $660,000 due under the MGHIF Note, net of discounts and financing costs (see Note 5 “MGHIF Financing”). . The Company did not have any long-term debt as of December 31, 2017. 333 The Company drew down on two of three Bridge Financing Notes (see discussion in Note 2 "Going Concern and Management’s Plans”) during June and July of 2017. The outstanding Bridge Financing Notes were repaid in full subsequent to the closing of the July 2017 Public Offering. The Company accounted for the embedded conversion option granted to jVen Capital in the Bridge Financing Notes as a mark-to-market derivative financial instrument carried at fair value. Changes in fair value of the embedded conversion option were reflected in earnings during the period of change. The embedded conversion option was expensed along with the remaining unamortized discount at the date of the Bridge Financing Notes repayment. The warrants issued to jVen Capital and MGHIF are classified as mark-to-market liabilities under ASC 480 due to certain put features that allow the holder to put the warrant back to the Company for cash equal to the Black-Scholes value of the warrant upon a change of control or fundamental transaction. Total interest expense (including amortization of debt discounts and financing fees) on all debt instruments was $191,195 and $233,505 for the years ended December 31, 2018 and 2017, respectively. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders Equity Note [Abstract] | |
Stockholders' Equity | Note 7 - Stockholders’ Equity As of December 31, 2018, the Company has 50,000,000 shares of authorized common shares and 8,645,720 shares issued and outstanding, and 10,000,000 of authorized preferred shares, of which none were issued or outstanding. In September 2016, the Company entered into the Sales Agreement with Cowen pursuant to which the Company may offer and sell from time to time, up to an aggregate of $25 million of shares of its common stock through Cowen, as sales agent, with initial sales limited to an aggregate of $11.5 million. Pursuant to the Sales Agreement, Cowen may sell the shares of common stock by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act, including, without limitation, sales made by means of ordinary brokers’ transactions on The Nasdaq Capital Market or otherwise at market prices prevailing at the time of sale, in block transactions, or as otherwise directed by the Company. The Company pays Cowen compensation equal to % of the gross proceeds from the sales of common stock pursuant to the terms of the Sales Agreement. As of December 31, 2018, the Company has sold an aggregate of 690,247 shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $8.8 million, and gross proceeds of $9.4 million. During the year ended December 31, 2018, the Company sold 318,236 shares of its common stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $0.6 million, and gross proceeds of $0.6 million. In connection with the October 2018 Public Offering, the Company terminated the at the market offering. In the July 2017 Public Offering, the Company issued 18,164,195 units at $0.40 per unit, and 6,835,805 pre-funded units at $0.39 per pre-funded unit, raising gross proceeds of approximately $10 million and net proceeds of approximately $8.8 million. jVen Capital was one of the investors participating in the offering. Each unit included one twenty-fifth of a share of common stock and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. Each pre-funded unit included one pre-funded warrant to purchase one twenty-fifth of a share of common stock for an exercise price of $0.25 per share, and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. At closing, the outstanding Bridge Financing Notes issued to jVen Capital, were repaid in the principal amount of $1 million plus accrued interest of $6,438. All pre-funded warrants issued in the July 2017 Public Offering were exercised during the year ended December 31, 2017. In connection with the July 2017 Public Offering, the Company issued to its placement agent warrants to purchase 50,000 shares of common stock. The warrants issued to the Placement Agent have an exercise price of $12.50 per share and are exercisable for five years. In September 2017, the Company issued 15,843 shares of its common stock with an aggregate value of $110,000 to settle a dispute related to pre-Merger AdvanDx activities. In October 2017, the Company issued 2,898 shares of its common stock with an aggregate value of $23,245 to a vendor in exchange for consulting services. Following receipt of approval from stockholders at a special meeting of stockholders held on January 17, 2018, the Company filed an amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of common stock, at a ratio of one share for twenty-five shares, and to reduce the authorized shares of common stock from 200,000,000 to 50,000,000 shares. All share amounts and per share prices in this Annual Report have been adjusted to reflect the reverse stock split. In the February 2018 Public Offering, the Company issued 2,841,152 units at $3.25 per unit, and 851,155 pre-funded units at $3.24 per pre-funded unit, raising gross proceeds of approximately $12 million and net proceeds of approximately $10.7 million. Each unit included one share of common stock and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance. All 851,155 pre-funded warrants issued in the February 2018 Public Offering were exercised during the year ended December 31, 2018. In connection with the February 2018 Public Offering, the Company issued to its placement agent warrants to purchase 184,615 shares of common stock. The warrants issued to the Placement Agent have an exercise price of $4.0625 per share and are exercisable for five years. On October 22, 2018, the Company closed the October 2018 Public Offering of 2,220,000 shares of its common stock at a public offering price of $1.45 per share. The offering raised gross proceeds of approximately $3.2 million and net proceeds of approximately $2.8 million. Stock options In 2008, the Board adopted, and the stockholders approved, the 2008 Stock Option and Restricted Stock Plan (the “2008 Plan”), pursuant to which the Company’s Board of Directors may grant either incentive or non-qualified stock options or shares of restricted stock to directors, key employees, consultants and advisors. In April 2015, the Board adopted, and the Company’s stockholders approved, the 2015 Equity Incentive Plan (the “2015 Plan”); the 2015 Plan became effective upon the execution and delivery of the underwriting agreement for the Company’s IPO. Following the effectiveness of the 2015 Plan, no further grants have been made under the 2008 Plan. The 2015 Plan provides for the granting of incentive stock options within the meaning of Section 422 of the Code to employees and the granting of non-qualified stock options to employees, non-employee directors and consultants. The 2015 Plan also provides for the grants of restricted stock, restricted stock units, stock appreciation rights, dividend equivalents and stock payments to employees, non-employee directors and consultants. Under the 2015 Plan, the aggregate number of shares of the common stock authorized for issuance may not exceed (1) 54,200 plus (2) the sum of the number of shares subject to outstanding awards under the 2008 Plan as of the 2015 Plan’s effective date, that are subsequently forfeited or terminated for any reason before being exercised or settled, plus (3) the number of shares subject to vesting restrictions under the 2008 Plan as of the 2015 Plan’s effective date that are subsequently forfeited. In addition, the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. Shares subject to awards granted under the 2015 Plan that are forfeited or terminated before being exercised or settled, or are not delivered to the participant because such award is settled in cash, will again become available for issuance under the 2015 Plan. However, shares that have actually been issued shall not again become available unless forfeited. As of December 31, 2018, 50,863 shares remain available for issuance under the 2015 Plan. For the years ended December 31, 2018 and 2017, the Company recognized stock compensation expense as follows: Year Ended December 31, 2018 2017 Cost of services $ 964 $ 13,776 Research and development 241,122 237,103 General and administrative 574,244 603,787 Sales and marketing 45,951 56,732 $ 862,281 $ 911,398 No income tax benefit for stock-based compensation arrangements was recognized in the consolidated statements of operations due to the Company’s net loss position. As of December 31, 2018, the Company had unrecognized expense related to its stock options of $0.5 million, which will be recognized over a weighted average period of 7.6 years. A summary of the status of options granted is presented below as of and for the years ended December 31, 2018 and 2017: Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Outstanding at January 1, 2017 119,106 $ 44.00 8.6 $ 663,298 Granted 58,324 $ 17.58 Exercised (1,167 ) $ 7.01 $ 11,256 Forfeited (24,538 ) $ 36.31 Expired (12,330 ) $ 83.49 Outstanding at December 31, 2017 139,395 $ 31.16 8.3 $ 37,339 Granted 95,800 $ 3.84 Exercised — — Forfeited (18,812 ) $ 11.98 Expired (4,824 ) $ 56.12 Outstanding at December 31, 2018 211,559 $ 20.58 7.6 $ 522 Vested and expected to vest 211,559 $ 20.58 7.6 $ 522 Exercisable at December 31, 2018 10,445 $ 1.25 5.3 $ 522 The total fair value of options vested in the years ended December 31, 2018 and 2017 was $930,921 and $2,086,843, respectively. The fair value of each option grant was estimated at the date of grant using the Black-Scholes option pricing model based on the assumptions below: Year Ended December 31, 2018 2017 Annual dividend — — Expected life (in years) 5.25 - 6.25 5.25 - 6.25 Risk free interest rate 2.5 - 2.9% 1.8 - 2.3% Expected volatility 46.0 - 49.6% 44.2 - 53.0% Restricted stock units A summary of the status of restricted stock units granted is presented below as of and for the years ended December 31, 2018 and 2017: Number of Options Weighted- Average Grant Date Fair Value Unvested at January 1, 2017 750 $ 42.50 Granted 11,175 $ 6.93 Vested (6,025 ) $ 8.01 Forfeited — — Unvested at December 31, 2017 5,900 $ 31.16 Granted — — Vested (5,650 ) $ 8.93 Forfeited — — Unvested at December 31, 2018 250 $ 42.50 As of December 31, 2018, there was approximately $9,000 of unrecognized compensation cost related to restricted stock units, which is expected to be recognized over a weighted average period of 0.92 years. Stock purchase warrants At December 31, 2018 and 2017, the following warrants to purchase shares of common stock were outstanding: Outstanding at December 31, Issuance Exercise Price Expiration 2018 (1) 2017 (1) March 2008 $ 19,763.50 March 2018 — 2 November 2009 $ 197.75 November 2019 270 270 January 2010 $ 197.75 January 2020 270 270 March 2010 $ 197.75 March 2020 55 55 November 2011 $ 197.75 November 2021 212 212 December 2011 $ 197.75 December 2021 27 27 March 2012 $ 2,747.50 March 2019 165 165 February 2015 $ 165.00 February 2025 9,001 9,001 May 2015 $ 165.00 May 2020 138,310 138,310 May 2016 $ 32.81 May 2021 189,577 189,577 June 2016 $ 32.81 May 2021 82,035 82,035 June 2017 $ 19.50 June 2022 18,754 18,754 July 2017 $ 17.25 July 2022 6,350 6,350 July 2017 $ 12.50 July 2022 50,000 50,000 July 2017 $ 10.625 July 2022 1,000,003 1,000,003 February 2018 $ 4.06 February 2023 184,615 — February 2018 $ 3.25 February 2023 1,846,153 — 3,525,797 1,495,031 The warrants listed above were issued in connection with various equity, debt, preferred stock or development contract agreements. (1) Warrants to purchase fractional shares of common stock resulting from the reverse stock split on January 17, 2018 were rounded up to the next whole share of common stock on a holder by holder basis. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 8 - Income Taxes At December 31, 2018 and 2017, the Company had net deferred tax assets of $52,348,036 and $49,251,408, respectively, primarily consisting of NOL carryforwards, research and experimental (“R&E”) credits, and differences between depreciation and amortization recorded for financial statement and tax purposes. The Company’s net deferred tax assets at December 31, 2018 and 2017 have been offset by a valuation allowance of $52,348,036 and $49,251,408, respectively. The valuation allowance has been recorded due to the uncertainty of realization of the deferred tax assets. The Company’s deferred tax assets and liabilities as of December 31, 2018 and 2017 are as follows: December 31, 2018 2017 Deferred tax assets: NOL carryforward $ 49,480,731 $ 46,326,407 R&E credit carryforward 2,559,479 2,559,479 Share-based compensation 329,796 345,088 Inventory reserve 19,068 45,338 Depreciation — 71,756 Interest expense 51,152 — Accruals and other 284,662 247,093 Total deferred tax assets 52,724,888 49,595,161 Valuation allowance (52,348,036 ) (49,251,408 ) Deferred tax liabilities: Intangible assets (256,011 ) (343,753 ) Depreciation (120,841 ) — Net $ — $ — The difference between the Company’s expected income tax provision (benefit) from applying federal statutory tax rates to the pre-tax loss and actual income tax provision (benefit) relates to the effect of the following: 2018 2017 Federal income tax benefit at statutory rates 21.0 % 34.0 % Permanent adjustment (1.4 )% — Provision to return adjustment (0.2 )% — State income tax benefit, net of Federal benefit (6.4 )% 6.8 % Tax reform impact — (134.5 )% Change in valuation allowance (13.0 )% 93.0 % Change in state tax rates and other — 0.7 % 0.0 % 0.0 % The Company has federal NOL carryforwards of $178,163,456 and $165,981,195 at December 31, 2018 and 2017, respectively. The NOL carryforwards incurred prior to 2018 begin to expire in 2022. Under the Tax Cuts and Jobs Act (the Tax Act), the amount of post 2017 NOLs that we are permitted to deduct in any taxable year is limited to 80% of our taxable income in such year, where taxable income is determined without regard to the NOL deduction itself. In addition, the Tax Act generally eliminates the ability to carry back any NOL to prior taxable years, while allowing post 2017 unused NOLs to be carried forward indefinitely. Utilization of the NOL carryforward may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code. There can be no assurance that the NOL carryforward will ever be fully utilized. To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Internal Revenue Code of 1986, as amended. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized. In December 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the "Tax Act"), most of the provisions of which took effect starting in 2018. The Tax Act made broad and complex changes to the U.S. tax code, including, but not limited to: (i) reducing the U.S. federal corporate tax rate from 35 percent to 21 percent; (ii) eliminating the corporate alternative minimum tax (AMT) and changing how existing AMT credits can be realized; (iii) creating a new limitation on deductible interest expense; and (iv) changing rules related to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017; and (v) changing the U.S. federal taxation of earnings of foreign subsidiaries. The U.S. change in federal taxation for foreign subsidiary earnings included a one-time toll charge on deemed repatriated earnings of foreign subsidiaries as of December 31, 2017. As a result of the accumulated losses in the Company’s foreign subsidiary, the Company had no toll tax liability for the tax year ended December 31, 2017. For 2018, the Company considered in its estimated annual effective tax rate additional provisions of Tax Reform including changes to the deduction for interest expense pursuant to IRC Section 163(j) interest limitation. As a result, the most significant impact on the Company’s consolidated financial statements was the reduction of approximately $14.6 million of the deferred tax assets related to net operating losses and other deferred tax assets. Such reduction is offset by a change in the Company’s valuation allowance. Additionally, the Company has foreign subsidiaries. At December 31, 2017 and November 2, 2017, the cumulative earnings and profits of these entities were negative. Accordingly, the Company was not liable for the transition tax on foreign earnings enacted under the Tax Act. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | Note 9 - Commitments Operating leases The Company leases a facility in Gaithersburg, Maryland under an operating lease that expires Rent expense under the Company’s facility operating leases for the year ended December 31, 2018 and 2017 was $984,639 and $949,244, respectively. Capital leases The Company leases lab equipment, office furniture, and computer equipment under various capital leases. The leases expire at various dates through 2021. The leases require monthly principal and interest payments. Following is a schedule by year of the estimated future minimum payments under all operating and capital leases as of December 31, 2018: Year ending December 31, Capital Leases Operating Leases Total 2019 $ 508,114 $ 1,107,565 $ 1,615,679 2020 408,264 1,125,940 1,534,204 2021 104,579 535,250 639,829 2022 — 40,080 40,080 2023 and thereafter — — — Total 1,020,957 $ 2,808,835 $ 3,829,792 Less: amount representing interest (96,251 ) Less: amount representing service costs (88,172 ) Net present value of future minimum lease payments 836,534 Current maturities (399,345 ) Long-term maturities $ 437,189 Assets under capital leases were included in the following balance sheet categories as of December 31: 2018 2017 Laboratory and manufacturing equipment $ 1,563,346 $ 850,792 Office furniture and equipment 64,790 64,790 Computers and network equipment 24,350 24,350 Less accumulated amortization (749,480 ) (454,471 ) Capital lease assets, net $ 903,006 $ 485,461 Amortization expense associated with equipment under capital leases for the years ended December 31, 2018 and 2017 was $295,009 and $161,606, respectively, and is included within depreciation and amortization expense in the consolidated statements of operations. Registration and other stockholder rights In connection with the various investment transactions, the Company entered into registration rights agreements with stockholders, pursuant to which the investors were granted certain demand registration rights and/or piggyback and/or resale registration rights in connection with subsequent registered offerings of the Company’s common stock. Restructuring In early June 2017, the Company commenced a restructuring of its operations to improve efficiency and reduce its cost structure. There were approximately $121,000 of one-time termination benefits that were recognized during the year ended December 31, 2017 related to the restructuring. The Company does not anticipate any further one-time termination benefits related to the restructuring plan. Retention agreements were issued to certain employees in which retention bonuses are earned and paid upon the completion of a designated service period. The service periods ended in December 2017. The Company incurred total retention expense of approximately $68,000 during the year ended December 31, 2017. The future minimum lease payments for the Woburn facility were approximately $1.4 million as of December 31, 2018. A liability for costs that will continue to be incurred under a contract for its remaining term without economic benefit to the entity shall be recognized at the cease-use date. If the contract is an operating lease the fair value of the liability at the cease-use date shall be determined based on the remaining lease rentals, adjusted for the effects of any prepaid or deferred items recognized under the lease, and reduced by estimated sublease rentals that could be reasonably obtained for the property. The Company expects the cease-use date for the Woburn facility to be in the first quarter of 2019. We do not believe there will be significant additional costs related to restructuring outside of what is described herein. Supply In June 2017, the Company entered into an agreement with Life Technologies Corporation, a subsidiary of Thermo Fisher Scientific (“LTC”) to supply the Company with Thermo Fisher Scientific’s QuantStudio 5 Real-Time PCR Systems (“QuantStudio 5”) to be used to run OpGen’s Acuitas AMR Gene Panel tests. Under the terms of the agreement the Company must notify LTC of the number of QuantStudio 5s that it commits to purchase in the following quarter. As of December 31, 2018 the Company has acquired fifteen QuantStudio 5s including eleven in the twelve months ended December 31, 2018. As of December 31, 2018 the Company has committed to acquiring an additional three QuantStudio 5s at a total cost of approximately $135,000 in the next three months. |
License Agreements, Research Co
License Agreements, Research Collaborations and Development Agreements | 12 Months Ended |
Dec. 31, 2018 | |
License Agreements Research Collaborations And Development Agreements [Abstract] | |
License Agreements, Research Collaborations and Development Agreements | Note 10 - License Agreements, Research Collaborations and Development Agreements The Company is a party to one license agreement to acquire certain patent rights and technologies related to its FISH product line. Royalties are incurred upon the sale of a product or service which utilizes the licensed technology. Certain of the agreements require the Company to pay minimum royalties or license maintenance fees. The Company recognized net royalty expense of $250,000 and $257,186 for the years ended December 31, 2018 and 2017, respectively. Annual future minimum royalty fees are $250,000 under these agreements. In September 2017, the Company was awarded a contract from the Centers for Disease Control and Prevention (“CDC”) to develop smartphone-based clinical decision support solutions for antimicrobial stewardship, or AMS, and infection control in low- and middle-income countries. The one-year $860,000 award began September 30, 2017 and funds development and evaluation of cloud-based mobile software. The Company worked with subcontractors Ilúm, LLC, an affiliate of Merck, and Universidad El Bosque (“UEB”) of Bogota, Colombia under this CDC contract. During the years ended December 31, 2018 and 2017, In June 2016, the Company entered into a license agreement with Hitachi, pursuant to which it resolved various matters with respect to previously delivered milestones under the technology development agreement and provided a development license and commercial products license to certain technology. The license agreement contains non-contingent multiple elements (the licenses) that the Company determined did not have stand alone value, and a contingent substantive milestone. The licenses are treated as a single unit of accounting and the Company will recognize the revenue associated with that unit of accounting over the applicable license period. During the years ended December 31, 2018 and 2017, the Company recognized $12,397 and $25,000 of revenue related to the license agreement, respectively. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 11 - Related Party Transactions In October 2016, the Company entered into an agreement with Merck Sharp & Dohme, a wholly-owned subsidiary of Merck Co. & Inc. (“Merck”), an affiliate of MGHIF, a principal stockholder of the Company and a related party to the Company. Under the agreement, Merck provided access to its archive of over 200,000 bacterial pathogens. The Company is initially performing molecular analyses on up to 10,000 pathogens to identify markers of resistance to support rapid decision making using the Acuitas Lighthouse, and to speed development of its rapid diagnostic products. Merck gains access to the high-resolution genotype data for the isolates as well as access to the Acuitas Lighthouse informatics to support internal research and development programs. The Company is required to expend up to $175,000 for the procurement of materials related to the activities contemplated by the agreement. Contract life-to-date, the Company has incurred $171,646 of procurement costs which have been recognized as research and development expense, including $22,603 and $146,177 during the years ended December 31, 2018 and 2017. In December 2017, we entered into a subcontractor agreement with ILÚM Health Solutions, LLC, an entity created by Merck’s Healthcare Services and Solutions division, whereby ILÚM Health Solutions provided services to the Company in the performance of the Company’s CDC contract to deploy ILÚM’s commercially-available cloud- and mobile-based software platform for infectious disease management in up to three medical sites in Colombia with the aim of improving antibiotic use in resource-limited settings. During the years ended December 31, 2018 and 2017, |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Note 12 - Fair Value Measurements The Company classifies its financial instruments using a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: • Level 1 - defined as observable inputs such as quoted prices in active markets; • Level 2 - defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and • Level 3 - defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions such as expected revenue growth and discount factors applied to cash flow projections. Financial assets and liabilities measured at fair value on a recurring basis The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the hierarchy. As part of the Company’s bridge financing and amendment to the MGHIF Note, the Company issued stock purchase warrants that the Company considers to be mark-to-market liabilities due to certain put features that allow the holder to put the warrant back to the Company for cash equal to the Black-Scholes value of the warrant upon a change of control or fundamental transaction. The Company determines the fair value of the warrant liabilities using the Black-Scholes option pricing model. Using this model, level 3 unobservable inputs include the estimated volatility of the Company’s common stock, estimated terms of the instruments, and estimated risk-free interest rates. The Company originally accounted for the conversion option embedded in the Bridge Financing Notes as a mark-to-market derivative financial instrument. The Company determined the fair value of the embedded conversion option liability using a probability-weighted expected return method. Using this method, level 3 unobservable inputs include the probability of default, the probability of a qualified financing, the probability of conversion, the estimated volatility of the Company’s common stock, estimated terms of the instruments, and estimated risk-free interest rates, among other inputs. The fair value of the conversion option was expensed at the time of repayment of the Bridge Financing Notes. The following table sets forth a summary of changes in the fair value of level 3 liabilities measured at fair value on a recurring basis for the year ended December 31, 2018: Description Balance at December 31, 2017 Change in Fair Value Balance at December 2018 Warrant liability $ 8,453 $ (8,386 ) $ 67 Financial assets and liabilities carried at fair value on a non-recurring basis The Company does not have any financial assets and liabilities measured at fair value on a non-recurring basis. Non-financial assets and liabilities carried at fair value on a recurring basis The Company does not have any non-financial assets and liabilities measured at fair value on a recurring basis. Non-financial assets and liabilities carried at fair value on a non-recurring basis The Company measures its long-lived assets, including property and equipment and intangible assets (including goodwill), at fair value on a non-recurring basis when they are deemed to be impaired. No such fair value impairment was recognized in the year ended December 31, 2018. |
Subsequent events
Subsequent events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent events |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The consolidated financial statements consolidate the operations of all controlled subsidiaries; all intercompany activity is eliminated. |
Foreign Currency | Foreign Currency The Company has subsidiaries located in Copenhagen, Denmark, and Bogota, Colombia, both of which use currencies other than the U.S. dollar as their functional currency. As a result, all assets and liabilities are translated into U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailing during the reporting period. Translation adjustments are reported in accumulated other comprehensive (loss)/income, a component of stockholders’ equity. Foreign currency translation adjustments are the sole component of accumulated other comprehensive (loss)/income at December 31, 2018 and 2017. Foreign currency transaction gains and losses, excluding gains and losses on intercompany balances where there is no current intent to settle such amounts in the foreseeable future, are included in the determination of net loss. Unless otherwise noted, all references to “$” or “dollar” refer to the United States dollar. |
Use of Estimates | Use of Estimates In preparing financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying consolidated financial statements, estimates are used for, but not limited to, liquidity assumptions, revenue recognition, share-based compensation, allowances for doubtful accounts and inventory obsolescence, and valuation of derivative financial instruments measured at fair value on a recurring basis, deferred tax assets and liabilities and related valuation allowance, depreciation and amortization and estimated useful lives of long-lived assets. Actual results could differ from those estimates. |
Fair value of financial instruments | Fair value of financial instruments Financial instruments classified as current assets and liabilities (including cash and cash equivalent, receivables, accounts payable, deferred revenue and short-term notes) are carried at cost, which approximates fair value, because of the short-term maturities of those instruments. For additional fair value disclosures, see Note 12. |
Cash and cash equivalents and restricted cash | Cash and cash equivalents and restricted cash The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the federal government agency (FDIC) insured limits of $250,000. The Company has not experienced any losses in such accounts, and management believes it is not exposed to any significant credit risk. As of December 31, 2018 and 2017, the Company had funds totaling $164,720 and $243,380, respectively, which are required as collateral for letters of credit benefiting its landlords and for credit card processors. These funds are reflected in other noncurrent assets on the accompanying consolidated balance sheets. |
Accounts Receivable | Accounts Receivable The Company’s accounts receivable result from revenues earned but not collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 to 60 days and are stated at amounts due from customers. The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, the Company’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operations when that determination is made. The allowance for doubtful accounts was $18,332 and $31,278 as of December 31, 2018 and 2017, respectively. At December 31, 2018, the Company had accounts receivable from one customer which individually represented 12% of total accounts receivable. At December 31, 2017, the Company had accounts receivable from one customer which individually represented 41% of total accounts receivable. For the year ended December 31, 2018, revenue earned from one customer represented 17% of total revenues. For the year ended December 31, 2017, revenue earned from one customer represented 11% of total revenues. |
Inventory | Inventory Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following: December 31, 2018 2017 Raw materials and supplies $ 368,438 $ 360,134 Work-in process 58,402 51,233 Finished goods 116,907 122,058 Total $ 543,747 $ 533,425 Inventory includes reagents and components for QuickFISH and PNA FISH kit products, and reagents and supplies used for the Company’s laboratory services. Inventory reserves for obsolescence and expirations were $71,270 and $155,507 at December 31, 2018 and 2017, respectively. |
Property and equipment | Property and equipment Property and equipment is stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets. The estimated service lives approximate three to five years. Depreciation expense was $463,068 and $401,272 for the years ended December 31, 2018 and 2017, respectively. Property and equipment consisted of the following at December 31, 2018 and 2017: December 31, 2018 2017 Laboratory and manufacturing equipment $ 4,829,323 $ 4,109,367 Office furniture and equipment 700,299 700,299 Computers and network equipment 1,520,713 1,505,651 Leasehold improvements 745,800 729,504 7,796,135 7,044,821 Less accumulated depreciation (6,574,308 ) (6,209,284 ) Property and equipment, net $ 1,221,827 $ 835,537 Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the years ended December 31, 2018 and 2017, the Company determined that its property and equipment was not impaired. |
Intangible assets and goodwill | Intangible assets and goodwill Intangible assets and goodwill as of December 31, 2018 and 2017 were acquired as part of a July 2015 merger transaction in which the Company acquired AdvanDx, Inc. and its subsidiary (the “Merger”) Finite-lived intangible assets Finite-lived intangible assets include trademarks, developed technology and customer relationships, and consisted of the following as of December 31, 2018 and 2017: December 31, 2018 December 31, 2017 Cost Accumulated Amortization Net Balance Accumulated Amortization Net Balance Trademarks and tradenames $ 461,000 $ (159,783 ) $ 301,217 $ (113,679 ) $ 347,321 Developed technology 458,000 (226,746 ) 231,254 (161,322 ) 296,678 Customer relationships 1,094,000 (541,105 ) 552,895 (384,817 ) 709,183 $ 2,013,000 $ (927,634 ) $ 1,085,366 $ (659,818 ) $ 1,353,182 Finite-lived intangible assets are amortized over their estimated useful lives. The estimated useful life of trademarks is 10 years, developed technology is 7 years, and customer relationships is 7 years. The Company reviews the useful lives of intangible assets when events or changes in circumstances occur which may potentially impact the estimated useful life of the intangible assets. Total amortization expense of intangible assets was $267,816 and $267,816 for the years ended December 31, 2018 and 2017, respectively. Expected amortization of intangible assets for each of the next five fiscal years is as follows Year Ending December 31, 2019 $ 267,816 2020 267,816 2021 267,816 2022 165,117 2023 46,104 Thereafter 70,697 Total $ 1,085,366 Finite-lived intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i.e., the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. During the years ended December 31, 2018 and 2017, the Company determined that its finite-lived intangible assets were not impaired. In accordance with ASC 360-10, the Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that long-lived assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets. During 2018, events and circumstances indicated the Company’s intangible assets might be impaired. However, management’s estimate of undiscounted cash flows indicated that such carrying amounts were expected to be recovered. Nonetheless, it is reasonably possible that the estimate of undiscounted cash flows may change in the near term, resulting in the need to write down those assets to fair value. Goodwill Goodwill represents the excess of the purchase price for AdvanDx, Inc. and subsidiary (collectively, “AdvanDx”) over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is not tax deductible in any relevant jurisdictions. The Company conducts an impairment test of goodwill on an annual basis as of October 1 of each year, and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value. As of December 31, 2018, the Company determined that its goodwill was not impaired. |
Deferred rent | Deferred rent Deferred rent is recorded and amortized to the extent the total minimum rental payments allocated to the current period on a straight-line basis exceed or are less than the cash payments required. |
Revenue recognition | Revenue recognition Subsequent to the Adoption of Accounting Standards Codification Revenue from Contracts with Customers (“ASC 606”) on January 1, 2018 The Company derives revenues from (i) the sale of QuickFISH and PNA FISH diagnostic test products and Acuitas AMR Gene Panel (RUO) test products, (ii) providing laboratory services, and (iii) providing collaboration services including funded software arrangements, and license arrangements. The Company analyzes contracts to determine the appropriate revenue recognition using the following steps: (i) identification of contracts with customers, (ii) identification of distinct performance obligations in the contract, (iii) determination of contract transaction price, (iv) allocation of contract transaction price to the performance obligations and (v) determination of revenue recognition based on timing of satisfaction of the performance obligation. The Company recognizes revenues upon the satisfaction of its performance obligation (upon transfer of control of promised goods or services to our customers) in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services. The Company defers incremental costs of obtaining a customer contract and amortizes the deferred costs over the period that the goods and services are transferred to the customer. The Company had no material incremental costs to obtain customer contracts in any period presented. Deferred revenue results from amounts billed in advance to customers or cash received from customers in advance of services being provided. For details about the Company’s revenue recognition policy prior to the adoption of ASC 606, refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2017. |
Research and development costs | Research and development costs Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and related expenses for personnel, other resources, laboratory supplies, fees paid to consultants and outside service partners. |
Share-based compensation | Share-based compensation Share-based compensation expense is recognized at fair value. The fair value of share-based compensation to employees and directors is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. A discussion of management’s methodology for developing each of the assumptions used in the Black-Scholes model is as follows: Fair value of common stock For periods prior to the Company’s IPO in May 2015, given the lack of an active public market for the common stock, the Company’s board of directors determined the fair value of the common stock. In the absence of a public market, and as an emerging company with no significant revenues, the Company believed that it was appropriate to consider a range of factors to determine the fair market value of the common stock at each grant date. The factors included: (1) the achievement of clinical and operational milestones by the Company; (2) the status of strategic relationships with collaborators; (3) the significant risks associated with the Company’s stage of development; (4) capital market conditions for life science and medical diagnostic companies, particularly similarly situated, privately held, early stage companies; (5) the Company’s available cash, financial condition and results of operations; (6) the most recent sales of the Company’s preferred stock; and (7) the preferential rights of the outstanding preferred stock. Since the IPO, the Company uses the quoted market price of its common stock as its fair value. Expected volatility Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Until a significant trading history for its common stock develops, the Company has identified several public entities of similar size, complexity and stage of development; accordingly, historical volatility has been calculated using the volatility of this peer group. Expected dividend yield The Company has never declared or paid dividends on its common stock and has no plans to do so in the foreseeable future. Risk-free interest rate This is the U.S. Treasury rate for the day of each option grant during the year, having a term that most closely resembles the expected term of the option. Expected term This is the period of time that the options granted are expected to remain unexercised. Options granted have a maximum term of 10 years. The Company estimates the expected term of the option to be 6.25 years for options with a standard four-year vesting period, using the simplified method. Over time, management will track actual terms of the options and adjust their estimate accordingly so that estimates will approximate actual behavior for similar options. |
Income taxes | Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized. Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority, assuming full knowledge of the position and all relevant facts. The Company had federal net operating loss (“NOL”) carryforwards of $178,163,456 and $165,981,195 at December 31, 2018 and 2017, respectively. Despite the NOL carryforwards, which begin to expire in 2022, the Company may have future tax liability due to alternative minimum tax or state tax requirements. Also, use of the NOL carryforwards may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”). To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Code. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever be fully utilized. |
Loss per share | Loss per share Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) stock purchase warrants, and (iii) restricted stock units representing the right to acquire shares of common stock which have been excluded from the computation of diluted loss per share, was 3.7 million shares and 1.6 million shares as of December 31, 2018 and 2017, respectively |
Accounting pronouncements adopted and not yet adopted | Adopted accounting pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) and International Accounting Standards Board (“IASB”) jointly issued a new revenue recognition standard, Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers On January 1, 2018, the Company adopted ASC 606, using the modified retrospective method. Results for reporting periods beginning subsequent to December 31, 2017 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with the Company’s historical accounting policies prior to adoption. In adopting the guidance, the Company applied the guidance to all contracts and used available practical expedients including assessing contracts with similar terms and conditions on a “portfolio” basis. The adoption of this new guidance did not have a material impact on the Company’s condensed consolidated financial statements. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows: Restricted Cash The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the statements of cash flows: December 31, 2018 December 31, 2017 December 31, 2016 Cash and cash equivalents $ 4,572,487 $ 1,847,171 $ 4,117,324 Restricted cash 164,720 243,380 243,380 Total cash, cash equivalents and restricted cash in the consolidated statements of cash flows $ 4,737,207 $ 2,090,551 $ 4,360,704 Accounting pronouncements not yet adopted In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) Leases (Topic 842) Targeted Improvements The new standard provides a number of optional practical expedients in transition. The Company expects to elect: (1) the ‘package of practical expedients’, which permits it not to reassess under the new standard its prior conclusions about lease identification, lease classification, and initial direct costs; (2) the use-of-hindsight; and (3) the practical expedient pertaining to land easements. In addition, the new standard provides practical expedients for an entity’s ongoing accounting that the Company anticipates making, such as the (1) the election for certain classes of underlying asset to not separate non-lease components from lease components and (2) the election for short-term lease recognition exemption for all leases that qualify. The Company will adopt ASC 842 as of January 1, 2019, using the alternative modified transition method. In preparation of adopting ASC 842, the Company is implementing additional internal controls to enable future preparation of financial information in accordance with ASC 842. The Company has also substantially completed its evaluation of the impact on the Company’s lease portfolio. The Company believes the largest impact will be on the consolidated balance sheets for the accounting of facilities-related leases, which represents a majority of its operating leases it has entered into as a lessee. These leases will be recognized under the new standard as ROU assets and operating lease liabilities. The Company will also be required to provide expanded disclosures for its leasing arrangements. As of December 31, 2018, the Company had $2.8 million of undiscounted future minimum operating lease commitments that are not recognized on its consolidated balance sheets as determined under the current standard. For a lessor, the results of operations are not expected to significantly change after adoption of the new standard. While substantially complete, the Company is still in the process of finalizing its evaluation of the effect of ASC 842 on the Company’s consolidated financial statements and disclosures. The Company will finalize its accounting assessment and quantitative impact of the adoption during the first quarter of fiscal year 2019. As the Company completes its evaluation of this new standard, new information may arise that could change the Company’s current understanding of the impact to leases. Additionally, the Company will continue to monitor industry activities and any additional guidance provided by regulators, standards setters, or the accounting profession, and adjust the Company’s assessment and implementation plans accordingly. In June 2018, the FASB issued ASU 2018-07: Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Inventories | Inventories are valued using the first-in, first-out method and stated at the lower of cost or net realizable value and consist of the following: December 31, 2018 2017 Raw materials and supplies $ 368,438 $ 360,134 Work-in process 58,402 51,233 Finished goods 116,907 122,058 Total $ 543,747 $ 533,425 |
Property, Plant and Equipment | Property and equipment consisted of the following at December 31, 2018 and 2017: December 31, 2018 2017 Laboratory and manufacturing equipment $ 4,829,323 $ 4,109,367 Office furniture and equipment 700,299 700,299 Computers and network equipment 1,520,713 1,505,651 Leasehold improvements 745,800 729,504 7,796,135 7,044,821 Less accumulated depreciation (6,574,308 ) (6,209,284 ) Property and equipment, net $ 1,221,827 $ 835,537 |
Schedule of Finite-Lived Intangible Assets | Finite-lived intangible assets include trademarks, developed technology and customer relationships, and consisted of the following as of December 31, 2018 and 2017: December 31, 2018 December 31, 2017 Cost Accumulated Amortization Net Balance Accumulated Amortization Net Balance Trademarks and tradenames $ 461,000 $ (159,783 ) $ 301,217 $ (113,679 ) $ 347,321 Developed technology 458,000 (226,746 ) 231,254 (161,322 ) 296,678 Customer relationships 1,094,000 (541,105 ) 552,895 (384,817 ) 709,183 $ 2,013,000 $ (927,634 ) $ 1,085,366 $ (659,818 ) $ 1,353,182 |
Schedule of Expected Amortization of Intangible Assets | Expected amortization of intangible assets for each of the next five fiscal years is as follows Year Ending December 31, 2019 $ 267,816 2020 267,816 2021 267,816 2022 165,117 2023 46,104 Thereafter 70,697 Total $ 1,085,366 |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the statements of cash flows: December 31, 2018 December 31, 2017 December 31, 2016 Cash and cash equivalents $ 4,572,487 $ 1,847,171 $ 4,117,324 Restricted cash 164,720 243,380 243,380 Total cash, cash equivalents and restricted cash in the consolidated statements of cash flows $ 4,737,207 $ 2,090,551 $ 4,360,704 |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Revenue From Contract With Customer [Abstract] | |
Schedule of Revenues by Type of Service | The Company provides diagnostic test products, laboratory services to hospitals, clinical laboratories and other healthcare provider customers, and enters into collaboration agreements with government agencies and healthcare providers December 31, 2018 2017 Product sales $ 2,395,626 $ 2,771,869 Laboratory services 34,665 41,960 Collaboration revenue 516,016 397,178 Total revenue $ 2,946,307 $ 3,211,007 |
Summary of Changes in Deferred Revenue | Changes in deferred revenue for the period were as follows: Balance at December 31, 2017 $ 24,442 Revenue recognized in the current period from the amounts in the beginning balance (14,450 ) New deferrals, net of amounts recognized in the current period 5,832 Balance at December 31, 2018 $ 15,824 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders Equity Note [Abstract] | |
Schedule of Company Recognized Stock Compensation Expense | For the years ended December 31, 2018 and 2017, the Company recognized stock compensation expense as follows: Year Ended December 31, 2018 2017 Cost of services $ 964 $ 13,776 Research and development 241,122 237,103 General and administrative 574,244 603,787 Sales and marketing 45,951 56,732 $ 862,281 $ 911,398 |
Summary of Status of Options Granted | A summary of the status of options granted is presented below as of and for the years ended December 31, 2018 and 2017: Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Outstanding at January 1, 2017 119,106 $ 44.00 8.6 $ 663,298 Granted 58,324 $ 17.58 Exercised (1,167 ) $ 7.01 $ 11,256 Forfeited (24,538 ) $ 36.31 Expired (12,330 ) $ 83.49 Outstanding at December 31, 2017 139,395 $ 31.16 8.3 $ 37,339 Granted 95,800 $ 3.84 Exercised — — Forfeited (18,812 ) $ 11.98 Expired (4,824 ) $ 56.12 Outstanding at December 31, 2018 211,559 $ 20.58 7.6 $ 522 Vested and expected to vest 211,559 $ 20.58 7.6 $ 522 Exercisable at December 31, 2018 10,445 $ 1.25 5.3 $ 522 |
Schedule of Fair Value of Option Grant Estimated Using Black-Scholes Option Pricing Model | The fair value of each option grant was estimated at the date of grant using the Black-Scholes option pricing model based on the assumptions below: Year Ended December 31, 2018 2017 Annual dividend — — Expected life (in years) 5.25 - 6.25 5.25 - 6.25 Risk free interest rate 2.5 - 2.9% 1.8 - 2.3% Expected volatility 46.0 - 49.6% 44.2 - 53.0% |
Summary of Status of Restricted Stock Unit Granted | A summary of the status of restricted stock units granted is presented below as of and for the years ended December 31, 2018 and 2017: Number of Options Weighted- Average Grant Date Fair Value Unvested at January 1, 2017 750 $ 42.50 Granted 11,175 $ 6.93 Vested (6,025 ) $ 8.01 Forfeited — — Unvested at December 31, 2017 5,900 $ 31.16 Granted — — Vested (5,650 ) $ 8.93 Forfeited — — Unvested at December 31, 2018 250 $ 42.50 |
Schedule of Warrants to Purchase Shares of Common Stock | At December 31, 2018 and 2017, the following warrants to purchase shares of common stock were outstanding: Outstanding at December 31, Issuance Exercise Price Expiration 2018 (1) 2017 (1) March 2008 $ 19,763.50 March 2018 — 2 November 2009 $ 197.75 November 2019 270 270 January 2010 $ 197.75 January 2020 270 270 March 2010 $ 197.75 March 2020 55 55 November 2011 $ 197.75 November 2021 212 212 December 2011 $ 197.75 December 2021 27 27 March 2012 $ 2,747.50 March 2019 165 165 February 2015 $ 165.00 February 2025 9,001 9,001 May 2015 $ 165.00 May 2020 138,310 138,310 May 2016 $ 32.81 May 2021 189,577 189,577 June 2016 $ 32.81 May 2021 82,035 82,035 June 2017 $ 19.50 June 2022 18,754 18,754 July 2017 $ 17.25 July 2022 6,350 6,350 July 2017 $ 12.50 July 2022 50,000 50,000 July 2017 $ 10.625 July 2022 1,000,003 1,000,003 February 2018 $ 4.06 February 2023 184,615 — February 2018 $ 3.25 February 2023 1,846,153 — 3,525,797 1,495,031 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Deferred Tax Assets and Liabilities | The Company’s deferred tax assets and liabilities as of December 31, 2018 and 2017 are as follows: December 31, 2018 2017 Deferred tax assets: NOL carryforward $ 49,480,731 $ 46,326,407 R&E credit carryforward 2,559,479 2,559,479 Share-based compensation 329,796 345,088 Inventory reserve 19,068 45,338 Depreciation — 71,756 Interest expense 51,152 — Accruals and other 284,662 247,093 Total deferred tax assets 52,724,888 49,595,161 Valuation allowance (52,348,036 ) (49,251,408 ) Deferred tax liabilities: Intangible assets (256,011 ) (343,753 ) Depreciation (120,841 ) — Net $ — $ — |
Expected Income Tax Provision (Benefit) from Applying Federal Statutory Tax Rates to the Pre-Tax Loss and Actual Income Tax Provision (Benefit) | The difference between the Company’s expected income tax provision (benefit) from applying federal statutory tax rates to the pre-tax loss and actual income tax provision (benefit) relates to the effect of the following: 2018 2017 Federal income tax benefit at statutory rates 21.0 % 34.0 % Permanent adjustment (1.4 )% — Provision to return adjustment (0.2 )% — State income tax benefit, net of Federal benefit (6.4 )% 6.8 % Tax reform impact — (134.5 )% Change in valuation allowance (13.0 )% 93.0 % Change in state tax rates and other — 0.7 % 0.0 % 0.0 % |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments For Capital Leases | Following is a schedule by year of the estimated future minimum payments under all operating and capital leases as of December 31, 2018: Year ending December 31, Capital Leases Operating Leases Total 2019 $ 508,114 $ 1,107,565 $ 1,615,679 2020 408,264 1,125,940 1,534,204 2021 104,579 535,250 639,829 2022 — 40,080 40,080 2023 and thereafter — — — Total 1,020,957 $ 2,808,835 $ 3,829,792 Less: amount representing interest (96,251 ) Less: amount representing service costs (88,172 ) Net present value of future minimum lease payments 836,534 Current maturities (399,345 ) Long-term maturities $ 437,189 |
Schedule of Capital Leased Assets | Assets under capital leases were included in the following balance sheet categories as of December 31: 2018 2017 Laboratory and manufacturing equipment $ 1,563,346 $ 850,792 Office furniture and equipment 64,790 64,790 Computers and network equipment 24,350 24,350 Less accumulated amortization (749,480 ) (454,471 ) Capital lease assets, net $ 903,006 $ 485,461 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following table sets forth a summary of changes in the fair value of level 3 liabilities measured at fair value on a recurring basis for the year ended December 31, 2018: Description Balance at December 31, 2017 Change in Fair Value Balance at December 2018 Warrant liability $ 8,453 $ (8,386 ) $ 67 |
Organization - Additional Infor
Organization - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2018Segment | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of operating business segment | 1 |
Going Concern and Management'_2
Going Concern and Management's Plans - Additional Information (Details) - USD ($) | Oct. 22, 2018 | Jul. 30, 2018 | Jul. 14, 2018 | Jun. 11, 2018 | Apr. 19, 2018 | Feb. 06, 2018 | Jul. 18, 2017 | Sep. 13, 2016 | Jul. 31, 2017 | Jul. 31, 2015 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2018 | Jun. 30, 2017 | May 31, 2017 |
Conversion Of Stock [Line Items] | |||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 597,743 | $ 3,808,836 | |||||||||||||
Net proceeds from sale of common stock and warrants | $ 13,530,401 | 8,754,882 | |||||||||||||
Bridge Financing Notes [Member] | Note Purchase Agreement [Member] | Maximum [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Aggregate principal amount | $ 1,500,000 | ||||||||||||||
Bridge Financing Note One [Member] | Note Purchase Agreement [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Aggregate principal amount | 500,000 | ||||||||||||||
Bridge Financing Note Two [Member] | Note Purchase Agreement [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Aggregate principal amount | 500,000 | ||||||||||||||
Bridge Financing Note Three [Member] | Note Purchase Agreement [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Aggregate principal amount | $ 500,000 | ||||||||||||||
MGHIF Financing Agreement [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 45,454 | ||||||||||||||
Shares issued, price per share | $ 110 | ||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 5,000,000 | ||||||||||||||
Aggregate principal amount | $ 1,000,000 | ||||||||||||||
MGHIF Financing Agreement [Member] | The Allonge [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Aggregate principal amount | $ 1,000,000 | ||||||||||||||
Accrued and unpaid interest | $ 285,512 | ||||||||||||||
Revised and extended maturity date for payment, terms | Six semi-annual payments | ||||||||||||||
Principal payments includes accrued and unpaid interest | $ 166,667 | ||||||||||||||
Beginning date of debt maturity | Jan. 2, 2019 | ||||||||||||||
Ending date of debt maturity | Jul. 1, 2021 | ||||||||||||||
Stock Purchase Warrants [Member] | Bridge Financing Notes [Member] | Note Purchase Agreement [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 19.50 | ||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 5,634 | ||||||||||||||
Warrants [Member] | Bridge Financing Notes [Member] | Note Purchase Agreement [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 17.25 | ||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 6,350 | ||||||||||||||
October 2018 Public Offering [Member] | Common Stock [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 2,220,000 | ||||||||||||||
Shares issued, price per share | $ 1.45 | ||||||||||||||
Gross proceeds from sale of common stock | $ 3,200,000 | ||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 2,800,000 | ||||||||||||||
Private Placement [Member] | Common Stock [Member] | MGHIF Financing Agreement [Member] | The Allonge [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 144,238 | ||||||||||||||
Accrued and unpaid interest | $ 285,512 | ||||||||||||||
Accrued and unpaid interest due date | Jul. 14, 2018 | ||||||||||||||
February 2018 Public Offering [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 2,841,152 | ||||||||||||||
Shares issued, price per share | $ 3.25 | ||||||||||||||
Gross proceeds from sale of common stock and warrants | $ 12,000,000 | ||||||||||||||
Net proceeds from sale of common stock and warrants | $ 10,700,000 | ||||||||||||||
Sale of stock, description of transaction | Each unit included one share of common stock and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. | ||||||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.5 | ||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 3.25 | ||||||||||||||
Warrants exercisable period | 5 years | ||||||||||||||
February 2018 Public Offering [Member] | Pre-funded Units [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 851,155 | ||||||||||||||
Shares issued, price per share | $ 3.24 | ||||||||||||||
February 2018 Public Offering [Member] | Pre-funded Warrants [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.01 | ||||||||||||||
Warrants exercised | 851,155 | 851,155 | |||||||||||||
July 2017 Public Offering [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 18,164,195 | ||||||||||||||
Shares issued, price per share | $ 0.40 | ||||||||||||||
Gross proceeds from sale of common stock and warrants | $ 10,000,000 | ||||||||||||||
Net proceeds from sale of common stock and warrants | $ 8,800,000 | ||||||||||||||
Sale of stock, description of transaction | Each unit included one twenty-fifth of a share of common stock and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. Each pre-funded unit included one pre-funded warrant to purchase one twenty-fifth of a share of common stock for an exercise price of $0.25 per share, and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. | ||||||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.04 | ||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 10.625 | ||||||||||||||
Warrants exercisable period | 5 years | ||||||||||||||
July 2017 Public Offering [Member] | Bridge Financing Notes [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Repayment of outstanding debt | $ 1,000,000 | $ 1,000,000 | |||||||||||||
July 2017 Public Offering [Member] | Pre-funded Units [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 6,835,805 | ||||||||||||||
Shares issued, price per share | $ 0.39 | ||||||||||||||
July 2017 Public Offering [Member] | Pre-funded Warrants [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Class of warrant or right, number of securities called by each warrant or right | 0.04 | ||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.25 | ||||||||||||||
At the Market Offering [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Stock issued during period, value, new issues | $ 597,743 | $ 3,808,836 | |||||||||||||
At the Market Offering [Member] | Sales Agreement [Member] | Cowen and Company, LLC [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Gross proceeds from sale of common stock | 600,000 | ||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | 600,000 | ||||||||||||||
Aggregate gross proceeds from issuance of common stock | 9,400,000 | $ 9,400,000 | |||||||||||||
Stock issued during period, value, new issues | $ 11,500,000 | ||||||||||||||
Aggregate net proceeds from sale of common stock | $ 8,800,000 | $ 8,800,000 | |||||||||||||
At the Market Offering [Member] | Sales Agreement [Member] | Maximum [Member] | Cowen and Company, LLC [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Aggregate gross proceeds from issuance of common stock | $ 25,000,000 | ||||||||||||||
At the Market Offering [Member] | Common Stock [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 318,236 | 227,216 | |||||||||||||
Stock issued during period, value, new issues | $ 3,182 | $ 2,272 | |||||||||||||
At the Market Offering [Member] | Common Stock [Member] | Sales Agreement [Member] | Cowen and Company, LLC [Member] | |||||||||||||||
Conversion Of Stock [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 318,236 | 690,247 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) shares in Millions | 12 Months Ended | |
Dec. 31, 2018USD ($)Customershares | Dec. 31, 2017USD ($)Customershares | |
Significant Accounting Policies [Line Items] | ||
FDIC limit of insurable cash | $ 250,000 | |
Letters of credit outstanding, amount | 164,720 | $ 243,380 |
Allowance for doubtful accounts receivable | $ 18,332 | $ 31,278 |
Number of individual customers accounting for more than 10% of accounts receivable | Customer | 1 | 1 |
Number of individual customers accounting for more than 10% of revenue | Customer | 1 | 1 |
Inventory valuation reserves | $ 71,270 | $ 155,507 |
Depreciation expense | 463,068 | 401,272 |
Amortization of intangible assets | 267,816 | 267,816 |
Impairment of finite-lived intangible assets | 0 | $ 0 |
Impairment of goodwill | $ 0 | |
Share-based compensation arrangement by share-based payment award, award vesting period | 4 years | |
Antidilutive securities excluded from computation of earnings per share, amount | shares | 3.7 | 1.6 |
ASU 2016-02 [Member] | ||
Significant Accounting Policies [Line Items] | ||
Undiscounted future minimum operating lease commitments | $ 2,800,000 | |
Domestic Country [Member] | ||
Significant Accounting Policies [Line Items] | ||
Operating loss carryforwards | $ 178,163,456 | $ 165,981,195 |
Operating loss carryforwards, expiration terms | begin to expire in 2022 | |
Trademarks and Trade Names [Member] | ||
Significant Accounting Policies [Line Items] | ||
Finite-lived intangible asset, useful life | 10 years | |
Developed Technology [Member] | ||
Significant Accounting Policies [Line Items] | ||
Finite-lived intangible asset, useful life | 7 years | |
Customer Relationships [Member] | ||
Significant Accounting Policies [Line Items] | ||
Finite-lived intangible asset, useful life | 7 years | |
Accounts Receivable [Member] | Customer One [Member] | Customer Concentration Risk [Member] | ||
Significant Accounting Policies [Line Items] | ||
Concentration risk, percentage | 12.00% | 41.00% |
Sales Revenue, Net [Member] | Customer One [Member] | Customer Concentration Risk [Member] | ||
Significant Accounting Policies [Line Items] | ||
Concentration risk, percentage | 17.00% | 11.00% |
Minimum [Member] | ||
Significant Accounting Policies [Line Items] | ||
Accounts receivable period due | 30 days | |
Estimated useful lives of related assets | 3 years | |
Fair value assumptions, expected term | 5 years 3 months | 5 years 3 months |
Minimum [Member] | Options [Member] | ||
Significant Accounting Policies [Line Items] | ||
Fair value assumptions, expected term | 6 years 3 months | |
Maximum [Member] | ||
Significant Accounting Policies [Line Items] | ||
Accounts receivable period due | 60 days | |
Estimated useful lives of related assets | 5 years | |
Fair value assumptions, expected term | 6 years 3 months | 6 years 3 months |
Maximum [Member] | Options [Member] | ||
Significant Accounting Policies [Line Items] | ||
Fair value assumptions, expected term | 10 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Inventories (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Inventories | ||
Raw materials and supplies | $ 368,438 | $ 360,134 |
Work-in process | 58,402 | 51,233 |
Finished goods | 116,907 | 122,058 |
Total | $ 543,747 | $ 533,425 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Property and Equipment (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | $ 7,796,135 | $ 7,044,821 |
Less accumulated depreciation | (6,574,308) | (6,209,284) |
Property and equipment, net | 1,221,827 | 835,537 |
Laboratory and Manufacturing Equipment [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | 4,829,323 | 4,109,367 |
Office Furniture and Equipment [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | 700,299 | 700,299 |
Computer Equipment [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | 1,520,713 | 1,505,651 |
Leasehold Improvements [Member] | ||
Significant Accounting Policies [Line Items] | ||
Property and equipment, Gross | $ 745,800 | $ 729,504 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Finite-Lived Intangible Assets (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Finite-Lived Intangible Assets [Line Items] | ||
Cost | $ 2,013,000 | $ 2,013,000 |
Accumulated Amortization | (927,634) | (659,818) |
Net Balance | 1,085,366 | 1,353,182 |
Trademarks and Tradenames [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 461,000 | 461,000 |
Accumulated Amortization | (159,783) | (113,679) |
Net Balance | 301,217 | 347,321 |
Developed Technology [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 458,000 | 458,000 |
Accumulated Amortization | (226,746) | (161,322) |
Net Balance | 231,254 | 296,678 |
Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Cost | 1,094,000 | 1,094,000 |
Accumulated Amortization | (541,105) | (384,817) |
Net Balance | $ 552,895 | $ 709,183 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Schedule of Expected Amortization of Intangible Assets (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Accounting Policies [Abstract] | ||
2,019 | $ 267,816 | |
2,020 | 267,816 | |
2,021 | 267,816 | |
2,022 | 165,117 | |
2,023 | 46,104 | |
Thereafter | 70,697 | |
Net Balance | $ 1,085,366 | $ 1,353,182 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Schedule of Reconciliation of Cash Cash Equivalents and Restricted Cash (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 4,572,487 | $ 1,847,171 | $ 4,117,324 |
Restricted cash | 164,720 | 243,380 | 243,380 |
Total cash, cash equivalents and restricted cash in the consolidated statements of cash flows | $ 4,737,207 | $ 2,090,551 | $ 4,360,704 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers - Schedule of Revenues by Type of Service (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Disaggregation Of Revenue [Line Items] | ||
Total revenue | $ 2,946,307 | $ 3,211,007 |
Product [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 2,395,626 | 2,771,869 |
Laboratory Services [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 34,665 | 41,960 |
Collaboration Revenue [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | $ 516,016 | $ 397,178 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Summary of Changes in Deferred Revenue (Details) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Revenue Recognition And Deferred Revenue [Abstract] | |
Balance at December 31, 2017 | $ 24,442 |
Revenue recognized in the current period from the amounts in the beginning balance | (14,450) |
New deferrals, net of amounts recognized in the current period | 5,832 |
Balance at December 31, 2018 | $ 15,824 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Additional Information (Details) | Dec. 31, 2018USD ($) |
Revenue From Contract With Customer [Abstract] | |
Contract with customers, asset | $ 0 |
Unsatisfied performance obligations related to contracts with customers | $ 0 |
MGHIF Financing - Additional In
MGHIF Financing - Additional Information (Details) - USD ($) | Jul. 30, 2018 | Jul. 14, 2018 | Jun. 11, 2018 | Jun. 28, 2017 | Jul. 31, 2015 | Dec. 31, 2018 | Dec. 31, 2017 |
Common Stock and Note Purchase Agreement [Line Items] | |||||||
Proceeds from issuance of common stock, net of issuance costs | $ 597,743 | $ 3,808,836 | |||||
MGHIF Financing Agreement [Member] | |||||||
Common Stock and Note Purchase Agreement [Line Items] | |||||||
Stock issued during period, shares, new issues | 45,454 | ||||||
Shares issued, price per share | $ 110 | ||||||
Proceeds from issuance of common stock, net of issuance costs | $ 5,000,000 | ||||||
Debt instrument, interest rate, stated percentage | 8.00% | ||||||
Debt instrument, face amount | $ 1,000,000 | ||||||
Unamortized debt issuance costs | $ 7,000 | ||||||
MGHIF Financing Agreement [Member] | The Allonge [Member] | |||||||
Common Stock and Note Purchase Agreement [Line Items] | |||||||
Debt instrument, face amount | $ 1,000,000 | ||||||
Accrued and unpaid interest | $ 285,512 | ||||||
Revised and extended the maturity date, payment terms | Six semi-annual payments | ||||||
Annual payments plus accrued and unpaid interest | $ 166,667 | ||||||
Beginning date of debt maturity | Jan. 2, 2019 | ||||||
Ending date of debt maturity | Jul. 1, 2021 | ||||||
MGHIF Financing Agreement [Member] | The Allonge [Member] | Common Stock [Member] | Private Placement [Member] | |||||||
Common Stock and Note Purchase Agreement [Line Items] | |||||||
Stock issued during period, shares, new issues | 144,238 | ||||||
Accrued and unpaid interest | $ 285,512 | ||||||
Stock issued during period, accrued and unpaid interest due | $ 285,512 | ||||||
Accrued and unpaid interest due date | Jul. 14, 2018 | ||||||
Amended and Restated MGHIF Financing Agreement [Member] | |||||||
Common Stock and Note Purchase Agreement [Line Items] | |||||||
Debt instrument, interest rate, stated percentage | 10.00% | ||||||
Debt instrument, extended maturity date | Jul. 14, 2018 | ||||||
Issuance of common stock warrants to purchase | 13,120 |
Debt - Additional Information (
Debt - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2018USD ($)Note | Dec. 31, 2017USD ($) | |
Debt Instrument [Line Items] | ||
Short-term debt | $ 398,595 | $ 1,010,961 |
Interest expense, debt | 191,195 | 233,505 |
Due in 2019 [Member] | ||
Debt Instrument [Line Items] | ||
Debt instrument, annual principal payment | 333,000 | |
Due in 2020 [Member] | ||
Debt Instrument [Line Items] | ||
Debt instrument, annual principal payment | 333,000 | |
Due in 2021 [Member] | ||
Debt Instrument [Line Items] | ||
Debt instrument, annual principal payment | 333,000 | |
MGHIF Financing Agreement [Member] | ||
Debt Instrument [Line Items] | ||
Short-term debt | 333,000 | 1,000,000 |
Long-term debt, outstanding | 660,000 | |
Notes Payable, Other Payables [Member] | ||
Debt Instrument [Line Items] | ||
Short-term debt | $ 65,000 | $ 56,000 |
Bridge Financing Notes [Member] | ||
Debt Instrument [Line Items] | ||
Number of notes | Note | 3 | |
Number of notes drew down | Note | 2 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) | Oct. 22, 2018USD ($)$ / sharesshares | Apr. 19, 2018shares | Feb. 06, 2018USD ($)$ / sharesshares | Jan. 17, 2018shares | Jul. 18, 2017USD ($)$ / sharesshares | Sep. 13, 2016USD ($) | Oct. 31, 2017USD ($)shares | Sep. 30, 2017USD ($)shares | Jul. 31, 2017USD ($) | Dec. 31, 2018USD ($)shares | Dec. 31, 2017USD ($)shares | Dec. 31, 2018USD ($)shares | Jan. 16, 2018shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Common stock, shares authorized | shares | 50,000,000 | 50,000,000 | 50,000,000 | 50,000,000 | 200,000,000 | ||||||||
Common stock, shares issued | shares | 8,645,720 | 2,265,320 | 8,645,720 | ||||||||||
Common stock, shares outstanding | shares | 8,645,720 | 2,265,320 | 8,645,720 | ||||||||||
Preferred stock, shares authorized | shares | 10,000,000 | 10,000,000 | 10,000,000 | ||||||||||
Preferred stock, shares issued | shares | 0 | 0 | 0 | ||||||||||
Preferred stock, shares outstanding | shares | 0 | 0 | 0 | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 597,743 | $ 3,808,836 | |||||||||||
Net proceeds from sale of common stock and warrants | $ 13,530,401 | 8,754,882 | |||||||||||
Stock split | On January 17, 2018, the Company filed an amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of common stock, at a ratio of one share for twenty-five shares, and to reduce the authorized shares of common stock from 200,000,000 to 50,000,000 shares. All share amounts and per share prices in this Annual Report have been adjusted to reflect the reverse stock split. | ||||||||||||
Reverse stock split conversion ratio | 0.04 | ||||||||||||
Share-based compensation, tax benefit from compensation expense | $ 0 | ||||||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, total | $ 500,000 | $ 500,000 | |||||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, period for recognition | 7 years 7 months 6 days | ||||||||||||
Share-based compensation arrangement by share-based payment award, options, vested in period, fair value | $ 930,921 | 2,086,843 | |||||||||||
Restricted Stock Units [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, period for recognition | 11 months 1 day | ||||||||||||
Employee service share-based compensation, non-vested awards, compensation cost not yet recognized, total | $ 9,000 | $ 9,000 | |||||||||||
2015 Plan [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | shares | 54,200 | 54,200 | |||||||||||
Share-based compensation arrangement by share-based payment award, description | the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’s Board of Directors. | ||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares available for grant | shares | 50,863 | 50,863 | |||||||||||
Share-based compensation arrangement by share-based payment award, common stock percentage | 4.00% | ||||||||||||
Common Stock [Member] | Pre-Merger Dispute Settlement [Member] | AdvanDx [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock issued during period, value, new issues | $ 110,000 | ||||||||||||
Stock issued during period, shares, new issues | shares | 15,843 | ||||||||||||
Common Stock [Member] | Vendor Consulting Services [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock issued during period, value, new issues | $ 23,245 | ||||||||||||
Stock issued during period, shares, new issues | shares | 2,898 | ||||||||||||
At the Market Offering [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock issued during period, value, new issues | $ 597,743 | 3,808,836 | |||||||||||
At the Market Offering [Member] | Sales Agreement [Member] | Cowen and Company, LLC [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Aggregate gross proceeds from issuance of common stock | 9,400,000 | $ 9,400,000 | |||||||||||
Stock issued during period, value, new issues | $ 11,500,000 | ||||||||||||
Maximum commission percentage on gross proceeds | 3.00% | ||||||||||||
Aggregate net proceeds from issuance of common stock | 8,800,000 | $ 8,800,000 | |||||||||||
Proceeds from issuance of common stock, net of issuance costs | 600,000 | ||||||||||||
Gross proceeds from sale of common stock | 600,000 | ||||||||||||
At the Market Offering [Member] | Sales Agreement [Member] | Maximum [Member] | Cowen and Company, LLC [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Aggregate gross proceeds from issuance of common stock | $ 25,000,000 | ||||||||||||
At the Market Offering [Member] | Common Stock [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock issued during period, value, new issues | $ 3,182 | $ 2,272 | |||||||||||
Stock issued during period, shares, new issues | shares | 318,236 | 227,216 | |||||||||||
At the Market Offering [Member] | Common Stock [Member] | Sales Agreement [Member] | Cowen and Company, LLC [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock issued during period, shares, new issues | shares | 318,236 | 690,247 | |||||||||||
July 2017 Public Offering [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock issued during period, shares, new issues | shares | 18,164,195 | ||||||||||||
Shares issued, price per share | $ / shares | $ 0.40 | ||||||||||||
Gross proceeds from sale of common stock and warrants | $ 10,000,000 | ||||||||||||
Net proceeds from sale of common stock and warrants | $ 8,800,000 | ||||||||||||
Sale of stock, description of transaction | Each unit included one twenty-fifth of a share of common stock and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. Each pre-funded unit included one pre-funded warrant to purchase one twenty-fifth of a share of common stock for an exercise price of $0.25 per share, and one common warrant to purchase one twenty-fifth of a share of common stock at an exercise price of $10.625 per share. | ||||||||||||
Class of warrant or right, number of securities called by each warrant or right | shares | 0.04 | ||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 10.625 | ||||||||||||
Warrants exercisable period | 5 years | ||||||||||||
July 2017 Public Offering [Member] | Placement Agent [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 12.50 | ||||||||||||
Warrants exercisable period | 5 years | ||||||||||||
July 2017 Public Offering [Member] | Bridge Financing Notes [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Repayment of principal amount of outstanding debt | $ 1,000,000 | $ 1,000,000 | |||||||||||
Repayments of accrued interest on outstanding debt | $ 6,438 | ||||||||||||
July 2017 Public Offering [Member] | Common Stock [Member] | Placement Agent [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Class of warrant or right, number of securities called by warrants or rights | shares | 50,000 | ||||||||||||
July 2017 Public Offering [Member] | Pre-funded Units [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock issued during period, shares, new issues | shares | 6,835,805 | ||||||||||||
Shares issued, price per share | $ / shares | $ 0.39 | ||||||||||||
July 2017 Public Offering [Member] | Pre-funded Warrants [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Class of warrant or right, number of securities called by each warrant or right | shares | 0.04 | ||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 0.25 | ||||||||||||
February 2018 Public Offering [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock issued during period, shares, new issues | shares | 2,841,152 | ||||||||||||
Shares issued, price per share | $ / shares | $ 3.25 | ||||||||||||
Gross proceeds from sale of common stock and warrants | $ 12,000,000 | ||||||||||||
Net proceeds from sale of common stock and warrants | $ 10,700,000 | ||||||||||||
Sale of stock, description of transaction | Each unit included one share of common stock and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. Each pre-funded unit included one pre-funded warrant to purchase one share of common stock for an exercise price of $0.01 per share, and one common warrant to purchase 0.5 share of common stock at an exercise price of $3.25 per share. | ||||||||||||
Class of warrant or right, number of securities called by each warrant or right | shares | 0.5 | ||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 3.25 | ||||||||||||
Warrants exercisable period | 5 years | ||||||||||||
February 2018 Public Offering [Member] | Placement Agent [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 4.0625 | ||||||||||||
Warrants exercisable period | 5 years | ||||||||||||
February 2018 Public Offering [Member] | Common Stock [Member] | Placement Agent [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Class of warrant or right, number of securities called by warrants or rights | shares | 184,615 | ||||||||||||
February 2018 Public Offering [Member] | Pre-funded Units [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock issued during period, shares, new issues | shares | 851,155 | ||||||||||||
Shares issued, price per share | $ / shares | $ 3.24 | ||||||||||||
February 2018 Public Offering [Member] | Pre-funded Warrants [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 0.01 | ||||||||||||
Warrants exercised | shares | 851,155 | 851,155 | |||||||||||
October 2018 Public Offering [Member] | Common Stock [Member] | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||
Stock issued during period, shares, new issues | shares | 2,220,000 | ||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 2,800,000 | ||||||||||||
Gross proceeds from sale of common stock | $ 3,200,000 | ||||||||||||
Shares issued, price per share | $ / shares | $ 1.45 |
Stockholders' Equity - Company
Stockholders' Equity - Company Recognized Stock Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | $ 862,281 | $ 911,398 |
Cost of Services [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 964 | 13,776 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 241,122 | 237,103 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | 574,244 | 603,787 |
Sales and Marketing [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allocated share-based compensation expense | $ 45,951 | $ 56,732 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Status of Options Granted (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stockholders Equity Note [Abstract] | |||
Number of Options, Outstanding Balance | 139,395 | 119,106 | |
Number of Options, Granted | 95,800 | 58,324 | |
Number of Options, Exercised | 0 | (1,167) | |
Number of Options, Forfeited | (18,812) | (24,538) | |
Number of Options, Expired | (4,824) | (12,330) | |
Number of Options, Outstanding Balance | 211,559 | 139,395 | 119,106 |
Number of Options, Vested and expected to vest | 211,559 | ||
Number of Options, Exercisable | 10,445 | ||
Weighted Average Exercise Price, Outstanding Balance | $ 31.16 | $ 44 | |
Weighted Average Exercise Price, Granted | 3.84 | 17.58 | |
Weighted Average Exercise Price, Exercised | 0 | 7.01 | |
Weighted Average Exercise Price, Forfeited | 11.98 | 36.31 | |
Weighted Average Exercise Price, Expired | 56.12 | 83.49 | |
Weighted Average Exercise Price, Outstanding Balance | 20.58 | $ 31.16 | $ 44 |
Weighted Average Exercise Price, Vested and expected to vest | 20.58 | ||
Weighted Average Exercise Price, Exercisable | $ 1.25 | ||
Weighted-Average Remaining Contractual Life, Outstanding (in years) | 7 years 7 months 6 days | 8 years 3 months 18 days | 8 years 7 months 6 days |
Weighted-Average Remaining Contractual Life, Vested and expected to vest (in years) | 7 years 7 months 6 days | ||
Weighted-Average Remaining Contractual Life, Exercisable (in years) | 5 years 3 months 18 days | ||
Aggregate Intrinsic Value, Outstanding | $ 37,339 | $ 663,298 | |
Aggregate Intrinsic Value, Exercised | 0 | 11,256 | |
Aggregate Intrinsic Value, Outstanding | 522 | $ 37,339 | $ 663,298 |
Aggregate Intrinsic Value, Vested and expected to vest | 522 | ||
Aggregate Intrinsic Value, Exercisable | $ 522 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Fair Value of Option Grant Estimated Using Black-Scholes Option Pricing Model (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Annual dividend | 0.00% | 0.00% |
Risk free interest rate, minimum | 2.50% | 1.80% |
Risk free interest rate, maximum | 2.90% | 2.30% |
Expected volatility, minimum | 46.00% | 44.20% |
Expected volatility, maximum | 49.60% | 53.00% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (in years) | 5 years 3 months | 5 years 3 months |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (in years) | 6 years 3 months | 6 years 3 months |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Status of Restricted Stock Unit Granted (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Stockholders Equity Note [Abstract] | ||
Number of Options, Outstanding Balance | 5,900 | 750 |
Number of Options, Granted | 0 | 11,175 |
Number of Options, Vested | (5,650) | (6,025) |
Number of Options, Forfeited | 0 | 0 |
Number of Options, Outstanding Balance | 250 | 5,900 |
Weighted Average Grant Date Fair Value, Outstanding Balance | $ 31.16 | $ 42.50 |
Weighted Average Grant Date Fair Value, Granted | 0 | 6.93 |
Weighted Average Grant Date Fair Value, Vested | 8.93 | 8.01 |
Weighted Average Grant Date Fair Value, Forfeited | 0 | 0 |
Weighted Average Grant Date Fair Value, Outstanding Balance | $ 42.50 | $ 31.16 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants to Purchase Shares of Common Stock (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of Common Stock Subject to Warrants | 3,525,797 | 1,495,031 |
March 2008 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 19,763.50 | |
Expiration | 2018-03 | |
Shares of Common Stock Subject to Warrants | 2 | |
November 2009 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2019-11 | |
Shares of Common Stock Subject to Warrants | 270 | 270 |
January 2010 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2020-01 | |
Shares of Common Stock Subject to Warrants | 270 | 270 |
March 2010 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2020-03 | |
Shares of Common Stock Subject to Warrants | 55 | 55 |
November 2011 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2021-11 | |
Shares of Common Stock Subject to Warrants | 212 | 212 |
December 2011 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 197.75 | |
Expiration | 2021-12 | |
Shares of Common Stock Subject to Warrants | 27 | 27 |
March 2012 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 2,747.50 | |
Expiration | 2019-03 | |
Shares of Common Stock Subject to Warrants | 165 | 165 |
February 2015 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 165 | |
Expiration | 2025-02 | |
Shares of Common Stock Subject to Warrants | 9,001 | 9,001 |
May 2015 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 165 | |
Expiration | 2020-05 | |
Shares of Common Stock Subject to Warrants | 138,310 | 138,310 |
May 2016 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 32.81 | |
Expiration | 2021-05 | |
Shares of Common Stock Subject to Warrants | 189,577 | 189,577 |
June 2016 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 32.81 | |
Expiration | 2021-05 | |
Shares of Common Stock Subject to Warrants | 82,035 | 82,035 |
June 2017 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 19.50 | |
Expiration | 2022-06 | |
Shares of Common Stock Subject to Warrants | 18,754 | 18,754 |
July 2017 [Member] | Exercise Price 17.25 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 17.25 | |
Expiration | 2022-07 | |
Shares of Common Stock Subject to Warrants | 6,350 | 6,350 |
July 2017 [Member] | Exercise Price 12.50 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 12.50 | |
Expiration | 2022-07 | |
Shares of Common Stock Subject to Warrants | 50,000 | 50,000 |
July 2017 [Member] | Exercise Price 10.625 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 10.625 | |
Expiration | 2022-07 | |
Shares of Common Stock Subject to Warrants | 1,000,003 | 1,000,003 |
February 2018 [Member] | Exercise Price 4.06 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 4.06 | |
Expiration | 2023-02 | |
Shares of Common Stock Subject to Warrants | 184,615 | |
February 2018 [Member] | Exercise Price 3.25 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise Price | $ 3.25 | |
Expiration | 2023-02 | |
Shares of Common Stock Subject to Warrants | 1,846,153 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax [Line Items] | ||
Deferred tax assets, net of valuation allowance, total | $ 52,348,036 | $ 49,251,408 |
Deferred tax assets, valuation allowance | $ 52,348,036 | $ 49,251,408 |
Maximum percentage of taxable income in which NOLs permitted to deduct | 80.00% | |
U.S. federal corporate tax rate | 21.00% | 34.00% |
Toll tax liability | $ 0 | |
Reduction of deferred tax assets | $ 14,600,000 | |
Maximum [Member] | ||
Income Tax [Line Items] | ||
U.S. federal corporate tax rate | 35.00% | |
Domestic Country [Member] | ||
Income Tax [Line Items] | ||
Operating loss carryforwards | $ 178,163,456 | $ 165,981,195 |
Operating loss carryforwards incurred prior to 2018, expiration terms | begin to expire in 2022 |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets: | ||
NOL carryforward | $ 49,480,731 | $ 46,326,407 |
R&E credit carryforward | 2,559,479 | 2,559,479 |
Share-based compensation | 329,796 | 345,088 |
Inventory reserve | 19,068 | 45,338 |
Depreciation | 0 | 71,756 |
Interest expense | 51,152 | 0 |
Accruals and other | 284,662 | 247,093 |
Total deferred tax assets | 52,724,888 | 49,595,161 |
Valuation allowance | (52,348,036) | (49,251,408) |
Deferred tax liabilities: | ||
Intangible assets | (256,011) | (343,753) |
Depreciation | (120,841) | 0 |
Net | $ 0 | $ 0 |
Income Taxes - Expected Income
Income Taxes - Expected Income Tax Provision (Benefit) from Applying Federal Statutory Tax Rates to the Pre-Tax Loss and Actual Income Tax Provision (Benefit) (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Federal income tax benefit at statutory rates | 21.00% | 34.00% |
Permanent adjustment | (1.40%) | |
Provision to return adjustment | (0.20%) | |
State income tax benefit, net of Federal benefit | (6.40%) | 6.80% |
Tax reform impact | (134.50%) | |
Change in valuation allowance | (13.00%) | 93.00% |
Change in state tax rates and other | 0.70% | |
Total | 0.00% | 0.00% |
Commitments - Additional Inform
Commitments - Additional Information (Details) | Dec. 31, 2018USD ($)Product | Dec. 31, 2018USD ($)Product | Dec. 31, 2017USD ($) |
Other Commitments [Line Items] | |||
Operating lease description | The Company leases a facility in Gaithersburg, Maryland under an operating lease that expires January 31, 2021, with one additional five-year renewal at the Company’s election. The Company also leases a facility in Woburn, Massachusetts under an operating lease that expires January 30, 2022. Additionally, the Company leases office space in Denmark; this lease is currently on a month-to-month basis. | ||
Operating leases, rent expense, net, total | $ 984,639 | $ 949,244 | |
Capital leases description | The Company leases lab equipment, office furniture, and computer equipment under various capital leases. The leases expire at various dates through 2021. The leases require monthly principal and interest payments. | ||
Capital leases expiration date description | The leases expire at various dates through 2021. | ||
Restructuring benefits recognized | 121,000 | ||
Retention expense incurred | 68,000 | ||
Future minimum operating lease payments | $ 2,808,835 | $ 2,808,835 | |
Designated service period of employees, description | The service periods ended in December 2017 | ||
QuantStudio 5 Real-Time PCR Systems [Member] | Life Technologies Corporation Supply Agreement [Member] | |||
Other Commitments [Line Items] | |||
Number of products acquired | Product | 15 | 11 | |
Committed to acquire total cost of additional products in next three months | $ 135,000 | $ 135,000 | |
Number of products committed to be acquired | Product | 3 | ||
Capital Lease Obligations [Member] | |||
Other Commitments [Line Items] | |||
Capital leases, income statement, amortization expense | $ 295,009 | $ 161,606 | |
Facility in Woburn, Massachusetts [Member] | |||
Other Commitments [Line Items] | |||
Future minimum operating lease payments | $ 1,400,000 | $ 1,400,000 | |
Facility in Woburn, Massachusetts [Member] | AdvanDx [Member] | |||
Other Commitments [Line Items] | |||
Operating leases expiration date | Jan. 30, 2022 | ||
Gaithersburg, Maryland Office Lease [Member] | |||
Other Commitments [Line Items] | |||
Operating leases expiration date | Jan. 31, 2021 | ||
Operating leases additional term | 5 years | 5 years |
Commitments - Schedule of Futur
Commitments - Schedule of Future Minimum Lease Payments For Capital Leases (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Capital Leases | ||
2,019 | $ 508,114 | |
2,020 | 408,264 | |
2,021 | 104,579 | |
Total | 1,020,957 | |
Less: amount representing interest | (96,251) | |
Less: amount representing service costs | (88,172) | |
Net present value of future minimum lease payments | 836,534 | |
Current maturities | (399,345) | $ (154,839) |
Long-term maturities | 437,189 | |
Operating Leases | ||
2,019 | 1,107,565 | |
2,020 | 1,125,940 | |
2,021 | 535,250 | |
2,022 | 40,080 | |
Total | 2,808,835 | |
Total | ||
2,019 | 1,615,679 | |
2,020 | 1,534,204 | |
2,021 | 639,829 | |
2,022 | 40,080 | |
Total | $ 3,829,792 |
Commitments - Schedule of Capit
Commitments - Schedule of Capital Leased Assets (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Loss Contingencies [Line Items] | ||
Less accumulated amortization | $ (749,480) | $ (454,471) |
Capital lease assets, net | 903,006 | 485,461 |
Laboratory and Manufacturing Equipment [Member] | ||
Loss Contingencies [Line Items] | ||
Capital leased assets gross | 1,563,346 | 850,792 |
Office Furniture and Equipment [Member] | ||
Loss Contingencies [Line Items] | ||
Capital leased assets gross | 64,790 | 64,790 |
Computers and Network Equipment [Member] | ||
Loss Contingencies [Line Items] | ||
Capital leased assets gross | $ 24,350 | $ 24,350 |
License Agreements, Research _2
License Agreements, Research Collaborations and Development Agreements - Additional Information (Details) | 1 Months Ended | 12 Months Ended | |
Sep. 30, 2017USD ($) | Dec. 31, 2018USD ($)Agreement | Dec. 31, 2017USD ($) | |
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Royalty expense | $ 250,000 | $ 257,186 | |
Annual future minimum royalty payments due | 250,000 | ||
Revenue | 2,946,307 | 3,211,007 | |
CDC [Member] | |||
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Number of contract awarded year | 1 year | ||
Revenue | $ 503,881 | 357,178 | |
CDC [Member] | Cloud-Based Mobile Software [Member] | |||
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Contract awarded value for funds development and evaluation of software | $ 860,000 | ||
FISH Product Line [Member] | |||
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Number of license agreements | Agreement | 1 | ||
Collaborations Revenue [Member] | |||
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Revenue | $ 516,016 | 397,178 | |
Collaborations Revenue [Member] | License Agreement with Hitachi [Member] | |||
License Agreements Research Collaborations And Development Agreements [Line Items] | |||
Revenue | $ 12,397 | $ 25,000 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) | 12 Months Ended | 26 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2018 | Oct. 31, 2016 | |
Service [Member] | ||||
Related Party Transaction [Line Items] | ||||
Cost of services | $ 625,516 | $ 520,338 | ||
Merck Sharp & Dohme Corp [Member] | ||||
Related Party Transaction [Line Items] | ||||
Research and development agreement description | Under the agreement, Merck provided access to its archive of over 200,000 bacterial pathogens. The Company is initially performing molecular analyses on up to 10,000 pathogens to identify markers of resistance to support rapid decision making using the Acuitas Lighthouse, and to speed development of its rapid diagnostic products. Merck gains access to the high-resolution genotype data for the isolates as well as access to the Acuitas Lighthouse informatics to support internal research and development programs. | |||
Maximum required amount to expend for procurement of materials | $ 175,000 | |||
Merck Sharp & Dohme Corp [Member] | Research and Development Expense [Member] | ||||
Related Party Transaction [Line Items] | ||||
Procurement costs recognized | $ 22,603 | 146,177 | $ 171,646 | |
ILÚM Health Solutions, LLC [Member] | Subcontractor Agreement | Service [Member] | ||||
Related Party Transaction [Line Items] | ||||
Cost of services | $ 329,162 | $ 210,180 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - Warrant Liability [Member] | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Changes in the fair value of Level 3 liabilities measured at fair value on recurring basis | |
Balance at the beginning of the period | $ 8,453 |
Change in Fair Value | (8,386) |
Balance at the end of the period | $ 67 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Fair Value on Non-Recurring Basis [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Financial assets measured at fair value | $ 0 |
Financial liabilities measured at fair value | 0 |
Impairment of non-financial assets and liabilities at fair value | 0 |
Fair Value on Recurring Basis [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Non-financial assets measured at fair value | 0 |
Non-financial liabilities measured at fair value | $ 0 |