SUNNYVALE, Calif., Dec. 19 /PRNewswire/ -- Biocircuits Corporation
(Nasdaq: BIOC) today announced it launched its Thyroid Stimulating Hormone
("TSH") assay. The TSH assay will be offered with the Company's IOS(R)
immunodiagnostic system to allow testing in physicians' offices and other
points of patient care.
"Currently, physicians in small- to medium-group settings are having to
incur the inefficiency of sending patient blood samples to outside
laboratories for TSH testing. The product launch of our TSH assay on the
second generation cartridge means physicians are now able to perform TSH
testing in their own offices quickly, conveniently and cost-effectively. We
believe this can increase the quality of care that physicians may offer to
their patients," said John Kaiser, President and Chief Executive Officer of
Biocircuits.
According to IMS, the number of TSH tests performed annually in the United
States has increased from nearly 31 million to approximately 49 million over
the past three years. Approximately 10 million Americans have a
thyroid-related condition that requires ongoing immunodiagnostic monitoring.
Fueling this 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.
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. It 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
used in the IOS system were a combined T4 and T Uptake assay to assess thyroid
function. In September 1996, the Company announced FDA clearance to market a
qualitative serum pregnancy assay, a test designed to allow physicians to
perform this common pregnancy test in their offices during the patient visit
in order to provide more immediate pre-natal care. In December 1996, the
Company announced FDA clearance to market 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 the 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
currently plans to continue developing additional immunodiagnostic assays that
are 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 10-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 Corp.
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