OraSure Technologies Submits UPlink Oral Fluid Point-Of-Care Drug Test Data To The FDA
This application was filed in order to provide certain additional data requested by the FDA in response to the Company's June 2001 510(k) submission for the UPlink(TM) reader and five oral fluid drug tests.
The submitted data demonstrate that the UPlink(TM) test for opiates provides performance equivalent to that provided by the Company's laboratory-based test for opiates using its Intercept(R) oral fluid collection device.
The Company is continuing to work on gathering the additional data required by the FDA for the remaining UPlink(TM) oral fluid drug tests - cocaine, amphetamines, PCP and marijuana.
The first commercial sales of the UPlink(TM) point-of-care oral fluid drug system in the United States are expected to be in the non-regulated criminal justice market later this year. After receipt of FDA clearance, the product is expected to be marketed and sold in the workplace, occupational health and drug rehabilitation settings.
The Company has also begun laying the groundwork for the international launch of the product through its development partner, Drager Safety AG & Co. KGaA, which is also expected later this year.
Sam Niedbala, Chief Science Officer, explained, "Our development team has worked very hard to complete this submission and we are very pleased with the results. Now that this data has been submitted, we are poised to complete work on the remaining tests."
Mike Gausling, Chief Executive Officer, added, "We have reached this first important milestone and we must continue to focus on completing the submission for the full drug testing panel. We are anxious to begin selling the UPlink(TM) system in the United States and Europe as soon as possible."
OraSure Technologies currently manufactures and markets Intercept(R), the only FDA-cleared laboratory-based oral fluid drug test, and believes that its Intercept(R) and UPlink(TM) drug testing products will provide a total drug testing solution for its customers.
The size of the domestic market for laboratory-based, drugs of abuse testing is estimated at approximately $1.5 billion, involving more than 42 million specimens per year.
About Up-Converting Phosphor Technology (UPT(TM)) / UPlink(TM)
Up-Converting Phosphor Technology (UPT(TM)) is a proprietary label detection technology developed by OraSure Technologies and research partners, SRI International, Menlo Park, California, and Leiden University, The Netherlands. UPT(TM) uses phosphor particles that convert light from low energy (infrared) to high-energy visible light.
This rare optical process, not found in nature, is expected to make UPT(TM) useful as a reporter label to detect a wide variety of targets including drugs of abuse, infectious diseases, cancer markers, food pathogens, cardiac risk markers, and DNA probes. UPT(TM) particles produce zero background interference, which dramatically increases the potential sensitivity of any test system.
In addition, the many colors of particles allow simultaneous detection of multiple biological markers.
UPlink(TM) is OraSure Technologies' first product platform based on UPT(TM). UPlink(TM) is a point-of-care system comprised of an oral fluid sample collector, test cassette, and a reader developed for detecting drugs of abuse.
UPlink(TM) can deliver instrument-read results in ten minutes and is expected to dramatically improve turnaround time and reduce costs associated with traditional lab-based urine drug testing. The first test menu will target the "NIDA-5" drug test panel - marijuana, cocaine, opiates, amphetamines and PCP.
Additional tests for benzodiazepines, barbiturates, and methadone are expected to be developed.
Important Information
This press release contains certain forward-looking statements including with respect to revenues, sales, markets, products, and regulatory submissions. Actual results could be significantly different.
Factors that could affect results include the 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; ability to sell products internationally; 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; customer inventory practices and consolidations; equipment failures and ability to obtain needed raw materials and components; the impact of terrorism and civil unrest; and general business, political and economic conditions.
These and other factors are discussed more fully in the Securities and Exchange Commission filings of OraSure Technologies, including its Annual Report on Form 10-K for the year ended December 31, 2000, and most recent Quarterly Report on Form 10-Q.
Although forward-looking statements help to provide complete information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.
About OraSure Technologies
OraSure Technologies, Inc. is the market leader for oral fluid diagnostics. The Company develops, manufactures, and markets medical devices and diagnostic products for use by insurance companies, public health agencies, clinical laboratories, physicians' offices, and workplace sites. For more information on the Company, please visit www.orasure.com.
CONTACT: OraSure Technologies, Inc.
Ronald H. Spair, 610/882-1820
Investorinfo@orasure.com
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