SUNNYVALE, Calif., Jan. 13 /PRNewswire/ -- 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 the 510(k) application with the Food and Drug
Administration at the completion of the evaluation. The test undergoing
evaluation is PSA (Prostatic Specific Antigen), a marker used for the
diagnosis and management of Prostate cancer.
The clinical trial and 510(k) application is intended to support a claim
for the management of previously diagnosed Prostate cancer. Additional trials
and clinical data will be required to submit a PMA for a diagnostic claim.
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.
"Since its introduction, PSA has rapidly become one of the most widely used
cancer tests," stated John Kaiser, President and CEO. "Recent market data
suggests that approximately 13,000,000 requests for the test are generated by
the 36,000 physician office labs," he further stated. 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
PSA cartridge, cartridges for performing Digoxin and Free T4 tests have also
started clinical trials.
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.
SOURCE Biocircuits Corporation
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CONTACT: John Kaiser, President and CEO, 408-752-8706, or James Welch, Vice President and CFO, 408-752-8728, both of Biocircuits Corporation
CNOC: http://www.prnewswire.com or fax, 800-758-5804, ext. 113540
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