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Epitope Announces FDA Clearance of Oral Fluid Assay For Cannabanoids (Marijuana)

    BEAVERTON, Ore., Feb. 26 /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 Cannabanoids
Micro-Plate EIA (enzyme immunoassay) for use in the qualitative determination
of cannabanoids in oral fluid collected with the OraSure(R) Oral Specimen
Collection Device manufactured by Epitope, Inc.  This assay is intended to
detect the use of marijuana.  "STC and Epitope continue to develop the full
panel of products to allow drugs-of-abuse testing in oral fluids to become a
near term reality that will benefit a variety of areas where remote collection
and testing are needed," said Sam Niedballa, Ph.D., executive vice president,
research and development of STC.  This clearance related to cannabanoids is in
addition to recently announced clearances for use of OraSure to test for
cocaine and methamphetamine using other STC EIAs.
    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).  "With
each clearance we are a step closer to providing those organizations who test
for drugs a convenient, cost effective, and less embarrassing alternative to
current practices while enhancing control over chain-of-custody," said John
Morgan, president and chief executive officer of Epitope.
    The clearance of the oral fluid tests for cocaine, methamphetamine, and
cannabanoids are the first for the group of drugs that constitute the NIDA-5.
As the final members of the NIDA-5 are cleared, Epitope intends to market
combined drugs-of-abuse panels that will be tailored to specific market needs
using a single OraSure specimen in both the United States and internationally.
Epitope holds exclusive distribution rights for the STC OraSure-based assays
outside of 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
worldwide test volume and sales revenue comes from the United States.  Use of
the OraSure collection device for drug testing offers many advantages over
urine collection.  OraSure specimen collection offers an economic advantage
since it can be performed in any setting, thus avoiding the need for specially
prepared collection sites necessary to prevent the adulteration of urine.
OraSure collection also provides for better chain-of-custody than urine
because the collector, without embarrassment to the subject, can observe the
collection.  An additional benefit of OraSure testing is that the test result
can be conclusively linked to the test subject using DNA testing performed on
the same sample used for drug screening.  This provides an accurate method for
responding to legal challenges that positive drug tests are invalid due to
sample mix-up at the laboratory.
    Epitope believes that drug testing performed on OraSure samples will be
well received in all segments where drug testing is currently performed.  Due
to the advantages listed above, OraSure-based drug testing seems especially
well suited for three testing segments 1) government mandated drug testing,
such as testing of transportation workers (D.O.T.), defense contractors
(D.O.D.), and other governmental contractors; 2) forensic testing, including
applications in the criminal justice system, law enforcement, the courts, and
probation/parole programs, and 3) industrial testing for employment and drug
free workplace programs.
    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 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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