SUNNYVALE, Calif., Sept. 5 /PRNewswire/ -- Biocircuits Corporation
(Nasdaq: BIOC) today announced it has received clearance from the U.S.
Food & Drug Administration (FDA) to market its Qualitative Serum Pregnancy
assay.  The Serum Pregnancy assay will be offered with the Company's IOS(TM)
immunodiagnostic system to allow testing in physicians' offices and other
points of patient care.
    Currently, nearly six million Serum Pregnancy assays are ordered by U.S.
office-based physicians, approximately two-thirds of which are performed by a
facility outside physicians' offices.
    "This assay has the potential to expand further the testing capabilities
of our IOS system," said John Kaiser, President and Chief Executive Officer of
Biocircuits.  "The assay is designed to allow physicians to perform this
common pregnancy test in their office during the patient visit, where they can
provide rapid test results and more immediate pre-natal care to patients."
    The Company is in the process of developing an improved second generation
cartridge for new assays as well as the existing assays.  The Company
currently expects the improved cartridge to be available in the fourth
quarter, at which time it plans to launch the Serum Pregnancy assay.
    In March 1996, Biocircuits began selling its IOS immunodiagnostic system
and initial tests in the United States.  The IOS system incorporates a
low-cost, compact instrument and patented, disposable test cartridges and is
the first cost-effective, easy-to-use immunodiagnostic system available for
use in physicians' offices and other point-of-care sites.  The initial tests
for IOS were a combined T4 and T Uptake assay to assess thyroid function.  In
April 1996, the Company filed a 510(k) pre-market notification with the FDA
for a Thyroid Stimulating Hormone (TSH) assay, its third thyroid function
assay.
    Biocircuits is currently developing four additional assays: a Quantitative
hCG test to track the progress of early pregnancies, a PSA test for management
of prostrate cancer patients, a Digoxin test for monitoring the therapeutic
usage of this drug in the treatment of heart disease and a Free T4 test for
diagnosing true clinical thyroid status.  The Company plans to continue to
develop additional immunodiagnostic assays commonly requested by office-based
physicians.
    Biocircuits is targeting the approximately 41,000 small to medium-sized
physician office practices and free-standing alternate site laboratories which
are licensed under CLIA for high or moderate complexity testing.  Most of
these sites do not currently have an immunodiagnostic testing capability.  The
IOS system is approved for moderately complex testing.
    Biocircuits Corporation, based in Sunnyvale, California, is focused on the
development and commercialization of innovative and cost-effective
immunodiagnostic products.
    Actual results may differ materially from the above forward-looking
statements due to a number of important factors, and will be dependent upon
the Company's ability, directly or through third parties, to successfully
manufacture and market its existing products, as well as the timely
development and regulatory approval of additional products.  These factors are
more fully discussed in the Company's most recent Forms 10-K and 10-Q.

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