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Biocircuits Begins Clinical Evaluation for Free T4 Test Cartridge
SUNNYVALE, Calif. -- Biocircuits Corporation (Nasdaq: BIOC) announced today that clinical evaluation of a new test cartridge for use in the IOS(R) immunoassay system has begun with the anticipation of filing a 510(k) application with the Food and Drug Administration following completion of the evaluation. The cartridge undergoing evaluation determines the concentration of Free T4, a hormone produced by the Thyroid gland, and is used as an aid to diagnose thyroid disease.
"The internal and external clinical evaluation normally takes approximately 45 days," stated Mr. John Kaiser, President and CEO. He further stated that, "Filing of the 510(k) occurs within two or three weeks of completion of the evaluation and recent data indicates that the FDA is clearing in vitro diagnostic 510(k) applications in 90 to 180 days."
As is required by the recently signed exclusive worldwide marketing agreement with Becton Dickinson, selection of the next test cartridges to begin development for the IOS system will be done jointly by Becton Dickinson and Biocircuits. "Biocircuits currently plans to have two or three new tests in development at any given time and the decisions on next tests will be made following a January meeting with Becton Dickinson," stated Mr. Kaiser.
The IOS system is the first easy to use and economical system for performing immunoassays in the physician's office. Although approximately 36,000 sites currently have the requisite moderately complex license for performing such tests, most send the testing out to large laboratories since an appropriate system for performing such tests has not been available. Currently four cartridges are available for use on the system, a T4/T Uptake combination, TSH, T4/TSH combination and a Quantitative hCG cartridge. In addition to the Free T4 cartridge, a Digoxin cartridge is also in clinical evaluation and a PSA test is in late development stages.
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 1O-K and 1O-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 and CFO of Biocircuits Corporation, 408-752-8728, both of
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