SUNNYVALE, Calif., May 11 /PRNewswire/ -- Biocircuits Corporation
(Nasdaq: BIOC) today announced that it has filed a 510(k) pre-market
notification with the U.S. Food and Drug Administration (FDA) for marketing
clearance of its PSA assay. The PSA assay is designed to be used with the
Company's IOS(R) immunodiagnostic system to allow testing in physicians'
offices and other points of care.
PSA is a frequently used test to diagnose and monitor prostate cancer in
males.
In addition to the submission of the PSA assay, Biocircuits also has a
Digoxin test in clinical trials and recently received FDA clearance of a Free
T4 test.
The IOS system is the first easy-to-use and economical immunodiagnostic
system to be marketed to the approximately 36,000 smaller physician offices
that are currently licensed to do moderately complex testing. The current
menu of tests for use on the system includes three cartridges for diagnosing
and managing Thyroid disease and a cartridge for quantitative measurement of
hCG, used for managing difficult pregnancies.
Actual results may differ materially from the above forward looking
statements due to a number of important factors, and will be dependent upon
successfully manufacturing and marketing the existing and proposed products,
as well as the timely development and regulatory approval of additional
products. Additional risk factors are more fully discussed in the Company's
most recent reports on Form 1O-K for the fiscal year ended December 31, 1997.
SOURCE Biocircuits Corporation
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CONTACT:
John Kaiser, President and CEO, 408-752-8706,
or James Welch, Vice President & CFO, 408-752-8728, both of
Biocircuits Corporation
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