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Epitope Announces FDA Clearance of Oral Fluid Assay for Methamphetamine

    BEAVERTON, Ore., Feb. 9, /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
Methamphetamine Micro-Plate EIA (enzyme immunoassay) for use in the
qualitative determination of methamphetamine in oral fluid collected with the
OraSure(R) Oral Specimen Collection Device manufactured by Epitope, Inc.
"This clearance demonstrates the utility of the OraSure device as well as
validates STC's product development strength, especially in the area of
alternative fluids," said Sam Niedballa, Ph.D., executive vice president,
research and development of STC.  This clearance related to methamphetamine is
in addition to a recently announced approval for use of OraSure to test for
cocaine using another STC EIA.
    Under an agreement with Epitope, STC Technologies, Inc., has developed
OraSure based tests for cotinine, a metabolite of nicotine, and a group of
drugs commonly called the NIDA-5.  The NIDA-5 includes cocaine,
methamphetamine, cannabanoids (THC), opiates, and phencyclidine (PCP).  "We
are pleased with the speed at which we received our second clearance and we
are optimistic that we will have a complete set of oral fluid-based assays to
bring to market in the near future," said John Morgan, president and chief
executive officer of Epitope.
    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 outside the United States.
    In 1996, the worldwide market for laboratory-based drugs of abuse screens
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,
and 4) industrial testing for employment evaluation and drug free workplace
programs.  In each of those 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 legal 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 worksite 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 market.

Source: EPITOPE Inc.


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