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BEAVERTON, Ore., May 20 /PRNewswire/ -- Epitope, Inc. (Nasdaq: EPTO) today announced that its research partner, STC Technologies, Inc. (STC), located in Bethlehem, Pennsylvania, has received FDA clearance for the STC Cotinine Micro-Plate EIA (enzyme immunoassay) for use in the qualitative determination of cotinine in oral fluid collected with the OraSure(R) Oral Specimen Collection Device manufactured by Epitope, Inc. The Food and Drug Administration does not now regulate tests for the use of cotinine; if the FDA should classify cotinine as a drug requiring future regulation, Epitope will be positioned to continue OraSure sales for this area of testing. Under an agreement with Epitope, STC has developed OraSure based tests for a group of drugs and their metabolites commonly called the NIDA-5. The NIDA-5 includes cocaine, methamphetamine, cannabanoids (marijuana), opiates, and phencyclidine (PCP). Clearance has been received for cocaine, methamphetamine and marijuana (MC). Opiates and phencyclidine (PCP) have been submitted to the FDA and clearance is expected in the next few months. "The clearance of cotinine and the submissions of opiates and PCP have us on track to offer the market a new and exciting method for drug testing and continues to demonstrate the broad applicability of the OraSure collection platform to many diagnostic applications. Epitope and STC are diligently preparing for the launch of these products into carefully selected markets when FDA clearance has been received for the NIDA-5. A market study has been underway for the last month, and the level of interest in this new approach to drugs-of-abuse testing has been very high," said John W. Morgan, president and chief executive officer. Upon clearance of the remaining tests, Epitope intends to market a combined drugs-of-abuse panel that will detect any of the NIDA-5 drugs or their metabolites using a single OraSure specimen. Epitope holds exclusive distribution rights for the STC OraSure-based, drugs-of-abuse testing outside the United States. STC Technologies, Inc. is a privately held company that develops and markets proprietary clinical diagnostic tests and medical devices for use in clinical labs, physicians' 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 current focus is on products that use oral fluid in the detection of HIV infection, with emphasis in the life insurance and public health markets. Statements in this press release about future events or performance are forward-looking statements. The company's actual results could be quite different. Factors that could affect results include the extent of future use of oral testing and OraSure in the insurance industry; ability of the company to develop product distribution channels; development of competing products; changes in federal or state law or regulations; and loss of key personnel. Although forward-looking statements help to provide complete information about the company, readers should keep in mind that forward-looking statements are much less reliable than historical information. Source: EPITOPE Inc. Content of this page is copyright and reprinted here for educational and historical information. |
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