SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): April 2, 2001
ORASURE TECHNOLOGIES, INC.
--------------------------
(Exact name of issuer as specified in charter)
DELAWARE 1-10492 36-4370966
(State or Other (Commission (I.R.S. Employer
Jurisdiction file Identification
of Incorporation or number) Number)
Organization)
150 WEBSTER STREET
BETHLEHEM, PENNSYLVANIA 18015
(Address of principal executive offices)
(610) 882-1820
(Registrant's telephone number, including area code)
ITEM 5 - OTHER EVENTS.
OraSure Technologies, Inc. (the "Company") is filing a set of "Frequently Asked
Questions" and the answers to these questions. The Frequently Asked Questions
reflect information that experience has demonstrated to be often asked by
analysts and investors.
ORASURE TECHNOLOGIES, INC.
FREQUENTLY ASKED QUESTIONS
SEE "IMPORTANT INFORMATION REGARDING THE ANSWERS TO FREQUENTLY ASKED
QUESTIONS" BELOW (REVISED THROUGH APRIL 2, 2001)
WHAT IS ORASURE TECHNOLOGIES AND HOW LONG HAS IT BEEN IN BUSINESS?
OraSure Technologies is a new company resulting from the merger between Epitope,
Inc. (Nasdaq NM: EPTO) and STC Technologies, a closely held private company,
effective September 29, 2000. Our combined company leverages expertise in oral
fluid testing for infectious disease and drugs-of-abuse in order to extend the
reach of oral fluid testing to the benefit of millions of people. Epitope, Inc.
was incorporated in 1981 and STC Technologies was founded under the name of
SolarCare, Inc. in 1987. Neither of these companies continues to exist as a
separate corporate entity.
WHAT ARE ORASURE'S MAIN PRODUCTS?
OraSure's four platform technologies--OraQuick(R), OraSure(R), UPT(TM) and
UPlink(TM)-- provide the foundation for our growing line of products.
WHAT IS UP-CONVERTING PHOSPHOR TECHNOLOGY (UPT(TM))?
UPT(TM) is a proprietary label that can be applied to the detection of minute
quantities of various substances such as antibodies, antigens, proteins, and
DNA. UPT utilizes phosphorescent particles that up-convert infrared energy to
visible light. When used in conjunction with antibodies or DNA probes, UPT
particles produce virtually no background interference, which dramatically
increases the sensitivity of any test system. In addition to elimination of
interference, these particles are stable in a variety of biological specimens,
allow simultaneous detection of multiple biological markers, and allow for
miniaturization of the test platform.
WHAT IS UPT(TM) EXPECTED TO DO FOR THE COMPANY?
UPT is a major new label technology, improving sensitivity by up to three orders
of magnitude over existing label technologies. It has a broad array of potential
applications, including:
o Human clinical diagnosis for infectious disease, cancer, drugs-of-abuse,
allergies, and cardiac conditions.
o Biological diagnostic systems for food and environmental testing.
o Genomics and pharmacogenomics.
o Veterinary testing.
o Surgical imaging.
WHAT ARE ORASURE'S PRIMARY MARKETS?
OraSure's primary markets today include the infectious disease market, the
drugs-of-abuse testing market and insurance testing market. There are an
estimated 34 million HIV infected people in the world, making it a significant
public health issue - both domestically and internationally. Drugs-of-abuse
testing is a $1.5 billion market in the United States and is expected to grow
approximately 6% per year. OraSure Technologies currently sells oral fluid
diagnostic products to over 170 life insurance companies in the U.S. market.
DO ORASURE'S PRODUCTS HAVE FDA CLEARANCE/APPROVAL?
OraSure Technologies' OraSure HIV-1 is the only FDA approved oral fluid sample
collection device available for use in testing for antibodies to the HIV-1
virus. The OraSure HIV-1 Western Blot is an FDA approved confirmatory test for
use with an OraSure HIV-1 oral fluid sample. Also, Intercept, Q.E.D.,
Histofreezer, and selected MICRO-PLATE and AUTO-LYTE assays have FDA clearance.
FOR WHAT PRODUCTS IS THE COMPANY SEEKING FDA CLEARANCE/APPROVAL?
OraSure Technologies commenced U.S. clinical trials in August 2000 for OraQuick
HIV-1/2, with a goal of a pre-market approval submittal to the FDA in the second
quarter of 2001. Also, the UPlink system was submitted for FDA clearance in the
first quarter of 2001. FDA submission of an OraSure device-based hepatitis
testing service is expected in the first quarter of 2002.
WHO ARE ORASURE'S CUSTOMERS?
OraSure's medical devices and diagnostic products are used by public- and
private-sector clients, clinical laboratories, physicians' offices and in
workplace testing. OraSure is the leading supplier of oral fluid collection
devices and related assays to the life insurance industry and public health
markets for the detection of antibodies to HIV and other conditions. In
addition, OraSure supplies oral fluid testing solutions for drugs-of-abuse
testing and is developing new oral fluid tests for diabetes and Hepatitis C.
OraSure intends to leverage its UPT platform into licensing opportunities in a
variety of markets, such as food testing, environmental testing, and genomics.
WHERE ARE ORASURE'S PRODUCTS CURRENTLY DISTRIBUTED?
OraSure has worldwide coverage for its products
WHO ARE ORASURE'S PRINCIPAL PARTNERS?
OraSure's FDA approved oral fluid Western blot is marketed and distributed under
an exclusive arrangement with Organon Teknika Corporation.
In May 1999, OraSure contracted with LabOne, Inc. to market and provide oral
fluid analysis for the Intercept(TM) Drugs of Abuse product line in North
America for work-site drug testing. LabOne also provides laboratory services for
some of OraSure's public health clients.
In March 2000, OraSure signed a research and development agreement with Drager,
a European manufacturer and supplier of medical products for the purpose of
developing the UPlink system for rapid detection of drugs -of abuse in oral
fluid. Drager will distribute the product worldwide for roadside drug testing
and in select criminal justice applications.
In September 2000, OraSure signed a research and development agreement with
Meridian Bioscience (formerly Meridian Diagnostics). Meridian and OraSure will
work together to develop, manufacture and sell a broad range of point-of-care
tests for the rapid detection of parasites, gastrointestinal, and upper
respiratory diseases using the UPlink system. Meridian will distribute the
products worldwide.
In November 2000, OraSure signed a distribution agreement with Edison Africa for
distribution of the OraQuick product in South Africa and sub-Saharan Africa
through its sub-distributor, UCB, a large pharmaceutical company with key
relationships in the physician's community.
WHAT ARE ORASURE TECHNOLOGIES' PRIORITIES FOR THE REMAINDER OF 2001?
o Submit OraQuick HIV for FDA approval by the end of the second quarter,
2001, expand international distribution, and begin expanding the product
line to include other public health tests.
o Expand the UPlink product line to include other tests, targeting multiple
point-of-care applications.
o Launch Intercept into the criminal justice and drug rehabilitation
markets, and further penetrate the workplace testing market.
o Expand the OraSure product line to include other tests - syphilis,
hepatitis and diabetic markers.
o Complete new joint development agreements in other markets with UPT.
o Grow revenues by 50% in 2001, achieve profitability in the second half
of 2001 and for the year as a whole.
HOW DO I GET MORE INFORMATION?
You can reach OraSure's Investor Relations team via email at
investorinfo@orasure.com or by calling Michelle Sells at 503-641-6115.
IMPORTANT INFORMATION REGARDING THE ANSWERS TO FREQUENTLY ASKED QUESTIONS
The foregoing "Frequently Asked Questions" contain certain "forward-looking
statements," within the meaning of the Federal securities laws. These include
statements about expected revenues, earnings, future product performance or
development, expected regulatory filings and approvals, and views of future
industry or market conditions. Forward-looking statements are not guarantees of
future performance or results. Known and unknown factors could cause actual
performance or results to be materially different from those expressed or
implied in these statements. Some of these factors are: ability to market
products; impact of competitors, competing products and technology changes;
ability to develop, commercialize and market new products; market acceptance of
oral fluid testing products and up-converting phosphor technology products;
ability to fund research and development and other projects and operations;
ability to obtain and timing of obtaining necessary regulatory approvals;
ability to develop product distribution channels; uncertainty relating to patent
protection and potential patent infringement claims; ability to enter into
international manufacturing agreements; obstacles to international marketing and
manufacturing of products; loss or impairment of sources of capital; exposure to
product liability and other types of litigation; changes in international,
federal or state laws and regulations; changes in relationships with strategic
partners and reliance on strategic partners for the performance of critical
activities under collaborative arrangements; changes in accounting practices or
interpretation of accounting requirements; equipment failures and ability to
obtain needed raw materials and components; and general business and economic
conditions. These and other factors that could cause the forward-looking
statements to be materially different are described in greater detail in the
Company's most recent Annual Report on Form 10-K and Quarterly Report on Form
10-Q. Although forward-looking statements help to provide complete information
about future prospects, they may not be reliable.
The forward-looking statements contained in the answers to the "Frequently Asked
Questions" may become outdated over time. The Company does not assume any
responsibility for updating any forward-looking statements. From time-to-time,
statements made by the Company may modify or replace prior statements found in
the "Frequently Asked Questions" or other releases and investors should refer to
the most recently dated material available. Presenting information in the
"Frequently Asked Questions" or updating this information from time to time
should not be deemed an acknowledgement that such information is material or
otherwise required to be disclosed.
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned, hereunto duly authorized.
ORASURE TECHNOLOGIES, INC.
Date: April 2, 2001 By: /s/ Jack E. Jerrett
-------------------
Jack E. Jerrett
Vice President, General Counsel
and Secretary