Biocircuits Submits 510(k) to FDA for Marketing Clearance of Free T4 Assay|
SUNNYVALE, Calif. -- 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 Free T4 assay. The Free T4 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.
Free T4 is a hormone that is measured to aid in the diagnosis of thyroid disease. While use of the test is gaining popularity in the U.S., it is widely used outside of the U.S. and is important for any launch of the IOS system in Europe. When cleared, the Free T4 cartridge will complete the Thyroid disease diagnosis panel and will bring the total number of cartridges available for use on the system to five.
In addition to the submission of the Free T4 assay, Biocircuits also has cartridges for Digoxin, a cardiac drug, and PSA, a test for prostate cancer, in clinical trials.
"We are pleased with the product development progress because expansion of the test menu is very important to making the IOS system attractive to physicians," stated John Kaiser, President and CEO.
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. In October of 1997, Biocircuits signed an agreement granting exclusive worldwide sales and marketing rights, as well as instrument manufacturing rights, to Becton Dickinson and Company. Becton Dickinson sells a broad range of medical supplies and devices for use by health care professionals, medical research institutions and the general public.
Actual results may differ materially from the above forward looking statements due to a number of important factors, and will be dependent on Becton Dickinson successfully manufacturing the IOS instrument 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 Forms 10-K and 10-Q and the Company's resale Registration Statement No. 333-26079.
/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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