Our sales team actively engages with healthcare providers and their staffsstaff to emphasize the need for colorectal cancer screening, educate them on the value of our Cologuard test, and facilitate their ability to order the test. We focus on specific healthcare providers based on a combination of Cologuard order history and ordering potential.potential data. We also focus on healthcare provider groups and larger regional and national health systems.

We believe that our Oncotype IQprecision oncology tests compete primarily on the basis of the value of the quantitative information they provide, the clinical validation of thetheir utility, of our tests, thetheir level of adoption and reimbursement coverage, for our tests, theand their inclusion of our tests in clinical practice guidelines,guidelines. They are also supported by our ability to commercialize products through our clinical development platform, our ability to expand our sales efforts into new areas of medical practice as we launch new products, our collaborations with clinical study groups, the quality of our clinical laboratory, and the level of customer service we provide. While we believe that our Oncotype IQprecision oncology tests compete favorably with respect to these factors, to continue to do so we must innovate and adopt advanced technology, successfully market, sell and enhance our tests, obtain peer-reviewed publications of our clinical studies in a timely manner, continue to obtain positive reimbursement determinations, continue to expand in countries outside of the U.S., continue to develop our technological and clinical operations, encourage healthcare provider participation in Medicare-required information collection efforts, and successfully expand our reach into additional product markets, including through collaborations with third parties.

We may be subject to substantial penalties for violations of anti-fraud and abuse laws, including denial of payment and refunds or recoupments, suspension of payments from Medicare, Medicaid or other federal healthcare programs, and exclusion from participation in federal and state healthcare programs, as well as civil monetary and criminal penalties and imprisonment. Numerous federal and state agencies enforce the anti-fraud and abuse laws. In addition, private insurers may also bring private actions. In some circumstances, private whistleblowers are authorized to bring fraud suits on behalf of the government against providers and are entitled to receive a portion of any final recovery.

For at leastPrecision Oncology tests and the next 12 months, our ability to generate revenues will depend very substantially on the commercial success of our Cologuard and Oncotype DX breast cancer tests. There can be no assurance that we will develop or commercialize any other products or services that will generate significant revenue. The commercial successsuccessful commercialization of our tests and our ability to generate revenues will depend on a variety of factors, including the following:

Billing for diagnostic and laboratory services is a complex process. Laboratories bill many different payers including patients, private insurance companies, Medicare, Medicaid, and employer groups, all of which have different billing requirements. We are continuing to work with third-party payers to cover and reimburse our tests. If we are unsuccessful, we may not receivedifficulties receiving timely payment for the tests we perform, for patients on a timely basis, if at all, and we may not be able to provide services for patients with certain healthcare plans. We may have to litigate to enforce coverage obligations under Medicare laws and laws that mandate coverage for certain screening or diagnostic tests or to enforce contractual coverage obligations. Such litigation may be costly, may divert management attention from other responsibilities, may cause payers, including those not directly involved in the litigation, to resist contracting with us, and may ultimately prove unsuccessful for a variety of reasons. We may face lawsuits by government or commercial payers if they believe they have overpaid us for our test services

In addition to FDA marketing and promotion restrictions, several other types of state and federal healthcare fraud and abuse laws have been applied in recent years to restrict certain marketing practices in the healthcare product and service industry and to regulate billing practices and financial relationships with healthcare providers, hospitals and other healthcare providers. These laws include a federal law commonly known as the Medicare/Medicaid anti-kickback law, and several similar state laws, which prohibit payments intended to induce healthcare providers or others either to refer patients or to acquire or arrange for or recommend the acquisition of healthcare products or services. While the federal law applies only to referrals, products or services for which payment may be made by a federal healthcare program, state laws often apply regardless of whether federal funds may be involved. These laws constrain the sales, marketing and other promotional activities of manufacturers of medical devices and providers of laboratory services by limiting the kinds of financial arrangements, including sales programs, that may be used with hospitals, healthcare providers, laboratories and other potential purchasers or prescribers of medical devices and laboratory services. Other federal and state laws generally prohibit individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, or are for items or services that were not provided as claimed.

The FCPA prohibits any U.S. individual, business entity or employee of a U.S. business entity from offering or providing, directly or through a third party, including the distributors we rely on in certain markets, anything of value to a foreign government officialcomply with corrupt intent to influence an award or continuation of business or to gain an unfair advantage, whether or not such conduct violates local laws. In addition, it is illegal for a company that reports to the SEC to have false or inaccurate books or records or to fail to maintain a system of internal accounting controls. We are also required to maintain accurate information and control over sales and distributors’ activities that may fall within the purview of the FCPA, its books and records provisions and its anti-bribery provisions.

The HIPAA privacy, security, and breach notificationconsumer protection laws and regulations including the expanded requirements under HITECH, establish comprehensive federal standards with respectcould result in fines, penalties and damage to the usesour reputation and disclosures of protected health information (“PHI”) by health plans, healthcare providers and healthcare clearinghouses, in addition to setting standards to protect the confidentiality, integrity and security of PHI. The regulations establishhave a complex regulatory frameworkmaterial adverse effect on a variety of subjects, including:

As of December 31, 2020, we had federal, state, and foreign net operating loss carryforwards (“NOLs”) of approximately $1.55 billion, $709.2 million, and $4.3 million, respectively. In general, under Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change NOLs to offset future taxable income. An ownership change is generally defined as a greater than 50 percent change in equity ownership by value over a specified time period (generally three years). Given the Code’s broad definition, an ownership change could be the unintended consequence of otherwise normal market trading in our stock that is outside our control. An ownership change under Section 382 of the Code could also be triggered by certain strategic transactions. Additionally, tax law limitations may result in our NOLs expiring before we have the ability to use them. Pursuant to the Tax Cuts and Jobs Act (H.R. 1) of 2017, federal NOLs arising in tax years beginning after December 31, 2017 have an indefinite carryover period and may only be used to offset 80 percent of current year taxable income. For these reasons, even if we attain profitability, our ability to utilize our NOLs may be limited, potentially significantly so.adversely affected.

On October 26, 2020,September 12, 2023, we completed the acquisition of Base Genomics Limited, an epigenetics company working to set a new standard in DNA methylation analysis to detect cancer in its earliest stages. As part of the combination, we acquired all of the outstanding equity interestcapital stock of the company for an aggregate purchase price of $416.5 million in cash.

On March 3, 2020, we completed the acquisition of Paradigm Diagnostics,Resolution Bioscience, Inc. from Agilent Technologies, Inc. Resolution Bioscience develops and Viomics, Inc., two related companies, in transactions that are deemed to be a single business combination under Accounting Standards Codification ("ASC") 805. The acquired entities provide comprehensive genomic-based profiling tests that assist in the diagnosis and therapy recommendations for late-stage cancer. As part of the acquisition, we acquired all of the outstanding equity interests of the companies for an aggregate purchase price of $40.4 million, which consists of $32.2 million payable in shares of our common stock and $8.2 million which was settledcommercializes next-generation sequencing-based precision oncology solutions through a cash payment. Of the $32.2 million to be settled through the issuance of common stock, $28.8 million was issued as of December 31, 2020, and the remaining $3.4 million, which was withheld and may become payable as additional merger consideration, is includedCLIA certified lab based in other current liabilities in the consolidated balance sheet as of December 31, 2020.Kirkland, Washington. The acquisition provides us with a high-quality blood-based therapy selection platform, complementing our comprehensive, tissue-based OncoExTra test.

For the year ended December 31, 2020, our Screeningbilling systems and Precision Oncology laboratory service revenue was impacted by the effects of the COVID-19 outbreak as discussed above. In response to the pandemic, we are conducting COVID-19 testing, which has served as additional source of revenue outside our normal Screeningprocesses, including international contracting and Precision Oncology laboratory testing services.