/REPEATING TO CORRECT GARBLE/
SUNNYVALE, Calif., Nov. 26 /PRNewswire/ -- Biocircuits Corporation
(Nasdaq: BIOC) today announced it has received clearance from the U.S. Food
& Drug Administration ("FDA") to market its Thyroid Stimulating Hormone
("TSH") assay. The TSH assay will be offered with the Company's IOS(TM)
immunodiagnostic system to allow testing in physicians' offices and other
points of patient care.
Over the past three years, the number of TSH tests performed annually in
the United States has increased from nearly 31 million to approximately
49 million. Approximately 10 million Americans have a thyroid-related
condition that requires ongoing immunodiagnostic monitoring.
Fueling the increased demand for TSH testing is mounting interest and
support within the medical community. A recent study in The Journal of the
American Medical Association proposes routine TSH screening for men and women
35 and older. Using a cost-effectiveness model, the study concludes that
screening for mild thyroid failure with a TSH test is as cost-effective as
screening for more commonly tested medical conditions such as high cholesterol
or high blood pressure.
"We believe an expanded menu of tests is critical to market penetration.
Since the market launch of the IOS system, TSH has been the most frequently
requested test by physicians," said John Kaiser, President and Chief Executive
Officer of Biocircuits.
"The Company has developed a second generation cartridge. The Company
currently expects the new cartridge to be available in December, at which time
it plans to launch the TSH assay," continued John Kaiser.
"In the last twelve months, we have received FDA clearances on four tests
and have filed a 510(k) pre-market notification with the FDA for a fifth test
in September," said John Kaiser. "With these tests and our ongoing
development efforts, we believe we are well positioned to address the
physicians' office immunodiagnostic market."
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 the physicians' office and other point-of-care sites. The initial
tests for IOS were a combined T4 and T Uptake assay to assess thyroid
function. In September 1996, the Company announced the FDA clearance to
market a qualitative serum pregnancy assay, a test designed to allow
physicians to perform this common pregnancy test in their office during the
patient visit where they can provide more immediate pre-natal care to
patients. Also in September 1996, the Company filed a 510(k) pre-market
notification with the FDA for a Quantitative hCG assay, a test to track the
progress of early pregnancies. The second generation cartridge will be
required for the market launch of all new assays. In addition, existing
assays will be converted to the new cartridge in the near future.
Biocircuits is currently developing three additional assays: a PSA test
for management of prostate 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 and proposed 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 reports on Forms
10-K and 1O-Q and the Company's Resale Registration Statement No. 333-13673.
SOURCE Biocircuits Corp.
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CONTACT: John Kaiser, Chief Executive Officer, 408-752-8706, or Donald Hawthorne, Chief Financial Officer, 408-752-8705, both of Biocircuits Corporation
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