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Epitope Announces FDA Clearance of Oral Fluid Assay for Cotinine (Nicotine)

    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.


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