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BEAVERTON, Ore., Jan. 15 /PRNewswire/ -- Epitope, Inc. (Nasdaq: EPTO) today announced that its research partner, STC Technologies, Inc., located in Bethlehem, Pennsylvania, has received FDA clearance for the STC Cocaine Metabolite Micro-Plate EIA (enzyme immunoassay) Kit for use in detecting cocaine and cocaine metabolites in oral fluid collected with the OraSure(R)/EpiScreen(R) Oral Specimen Collection Device manufactured by Epitope. "This is the first oral fluid-based immunoassay for drugs of abuse cleared by the U.S. Food and Drug Administration," said Sam Niedbala, Ph.D., executive vice president, research and development of STC. Under an agreement with Epitope, STC has developed OraSure-based tests for cotinine, a metabolite of nicotine, and a group of drugs commonly called the NIDA-5. The NIDA-5 include cocaine, methamphetamines, cannabinoids (THC), opiates, and phencyclidine (PCP). Four oral fluid 510(k) submissions for cocaine, methamphetamine, THC and cotinine have been submitted to the FDA. Two additional 510(k) submissions for oral fluid opiates and PCP are expected during the first quarter of 1998. "This is Epitope's first step to expand our base technology beyond our current applications," said John Morgan, president and chief executive officer of Epitope. The clearance of the oral fluid test for cocaine is the first for any drugs included in the NIDA-5. Upon clearance of tests for other NIDA-5 drugs, Epitope intends to market a combined drugs-of-abuse panel that will detect any of the NIDA-5 drugs using a single OraSure specimen. Epitope holds exclusive distribution rights for the STC OraSure-based drugs-of-abuse assays outside the United States. In 1996, the worldwide market for laboratory-based, drugs-of-abuse testing was approximately $530 million, involving 35 million test panels. Over 60% of the worldwide test volume and sales revenue comes from the United States. Drugs-of-abuse testing generally occurs in one of four basic testing segments: 1) Clinical testing including hospital emergency rooms, laboratories, and drug rehabilitation centers, 2) government mandated testing, such as testing of transportation workers (D.O.T.), defense contractors (D.O.D.), and other governmental contractors, 3) forensic testing, including applications in the criminal justice system, law enforcement, the courts, and probation/parole programs, and 4) industrial testing for employment evaluation and drug-free workplace programs. In each of these segments OraSure testing will provide an alternative for sample collection that can be performed in any setting, is non-invasive, is less embarrassing, and improves the chain of custody. STC Technologies, Inc., is a privately held company that develops and markets proprietary clinical diagnostic tests and medical devices for use in clinical labs, physician's offices, and work-site testing. Since its founding in 1987, STC has twice been named to Inc. magazine's list of the 500 fastest growing, privately held companies in America. Epitope, Inc., is an Oregon based corporation that develops and markets medical diagnostic products. Its principal products, including the OraSure oral specimen collection device, focus on the use of oral fluid to detect HIV infection and other conditions, and are marketed primarily in the life insurance and public health sectors. Source: EPITOPE Inc. Content of this page is copyright and reprinted here for educational and historical information. |
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