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Epitope Announces Publication of Study Regarding its OraSure Oral HIV Antibody Testing System; New York State Approval of OraSure System

    BEAVERTON, Ore., Jan. 14 /PRNewswire/ -- Epitope, Inc. (Nasdaq: EPTO) said
its marketing partner, SmithKline Beecham Consumer Healthcare (NYSE: SBH) has
announced two important developments with respect to Epitope's OraSure(R)
HIV-1 antibody testing system.  Today's edition of the Journal of the American
Medical Association (JAMA) includes a study that shows OraSure is a highly
accurate alternative to blood testing.  Separately, the State of New York
recently cleared OraSure for use by physicians in that state.

          JAMA Study Underscores Accuracy of Oral HIV Antibody Test
Study Shows OraSure System to Be a Simple, Highly Accurate HIV Testing Option
                         No Blood or Needles Required

    The study published today in JAMA shows that the OraSure HIV-1 Antibody
Testing System, the first oral HIV antibody test, is a highly accurate
alternative to blood testing.  The study results are considered significant
because of the many advantages associated with a non-invasive method of
specimen collection for HIV testing.  All other HIV testing systems rely on
blood samples that require the use of needles or lancets.
    The OraSure HIV-1 System was cleared by the Food and Drug Administration
(FDA) last June.  The System is being marketed to health professionals by
SmithKline Beecham Consumer Healthcare (SBCH).  Epitope, Inc. developed the
OraSure System and manufactures both the OraSure specimen collection device
and the OraSure Western Blot Test Kit which is used to confirm positive
screening results.  Organon Teknika, a division of Akzo Nobel, manufactures
the Vironostika HIV-1 ELISA screening test which it distributes to
laboratories together with the OraSure Western Blot confirmatory test for use
in the OraSure HIV-1 System.
    Though we have known for ten yews that antibodies against HIV-1 can be
detected in the oral fluid of HIV-positive subjects, this is the first
reliable method for gathering and testing oral samples," said
John Fitchen, M.D., chief operating officer of Epitope Medical Products, who
was a lead investigator and co-author of the JAMA article.  "Our study
demonstrates definitively that test results using oral samples obtained with
OraSure are highly accurate, and that the OraSure system can be used in place
of blood testing."
    The OraSure technology uses a sample called oral mucosal transudate (OMT),
not saliva.  OMT is obtained using a specially treated pad that is placed
between the patient's gum and lower cheek for two minutes.  The pad is then
placed in a preservative and sent to a clinical laboratory, where it is tested
for the presence of HIV antibodies, the same way blood samples are tested.  A

single sample is sufficient for the initial screening test and for
confirmatory testing, if indicated.
    The study used specimens from 3,570 subjects collected at
11 geographically dispersed sites, including general medical and public health
clinics, blood banks, and clinics for HIV and other sexually transmitted
diseases.  Subjects ranged in age from 13 to 80.  The study measured the
accuracy of the OraSure System by comparing results with true HIV-1 antibody
status.  The results showed that the OraSure system provided the correct
result or would trigger appropriate follow-up testing in more than 99.9% of
the cases (3569/3570).  The study was a basis for FDA clearance of the OraSure
Western Blot Test Kit in June 1996.
    "While the OraSure System is currently approved by the FDA for
administration by a trained healthcare professional under the supervision of a
physician, this technology may prove to be well suited for use as a home test
in the future," said Dr. Fitchen.  Because it does not rely on a fingerstick
or other means to obtain a blood sample, OraSure should increase access To HIV
testing and therefore to counseling and early therapeutic intervention.
    "The availability of this noninvasive alternative to blood testing has a
number of important public health implications," said Donna Sturgess, director
of diagnostic products, SBCH.  "First, a system without needles or blood is
inherently safer for healthcare workers than a test involving blood
collection.  Second, many people reluctant to undergo a blood test for HIV
testing are willing to give an oral sample for this purpose.  And, third,
OraSure, which is portable and simple to use, requires minimal training, which
means it can reduce health personnel costs."

           OraSure Oral HIV-1 Test Now Available in New York State
     Opportunity for Physicians to Expand HIV Testing with New Technology

    OraSure HIV-1 Antibody Testing System is now available to physicians in
New York State, SBCH announced recently.  The OraSure technology -- which does
not require blood or needles -- provides a simple, highly accurate HIV testing
option and represents the first major breakthrough with the potential to
expand HIV testing in more than ten years.
    "New York leads America in AIDS-related deaths and illnesses.  New York
City has more than 15% of all cases, surpassing San Francisco, Miami,
Philadelphia and Los Angeles combined," stated Richard Sadovsky, M.D.,
Associate Professor of Family Medicine, State University of New York Health
Science Center at Brooklyn, and Past President, New York State Chapter,
American Academy of Family Physicians.  "Greater access to testing will help
more New Yorkers learn their HIV status and enable them to take proactive
steps to stay healthier longer."
    SmithKline Beecham Consumer Healthcare is a division of SmithKline
Beecham, one of the world's leading healthcare companies that discovers,
develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter
medicines, health-related consumer products and healthcare services including
clinical laboratory testing, disease management and pharmaceutical benefit
management.
    Organon Teknika, a division of Akzo Nobel, N.V. is active in hemostatis,
bacteriology, and immunodiagnostics in more than 100 countries.  An extensive
range of healthcare products and automated test systems are provided to
hospitals, blood banks, clinical, scientific and food-screening laboratories.
    Epitope is a biotechnology company that develops and markets medical
diagnostic products through its Epitope Medical Products group and superior
plants and related products through its Agritope group.
    Consumers and health professionals can receive detailed information about
OraSure by calling toll-free, 888-ORASURE (672-7873), ext. 400.  Information
is also available through OraSure's home page at "www.orasure.com."

Source: EPITOPE Inc.


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