SUNNYVALE, Calif., Dec. 16 /PRNewswire/ -- Biocircuits Corporation
(Nasdaq: BIOC) announced today that clinical evaluation of a new test
cartridge for use in the IOS(R) 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 for Digoxin, a heart drug
that is routinely monitored.
    "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 we hope to have the decisions on the next
tests in 30 to 60 days," 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 cartridge in clinical evaluation, 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 10-K and 10-Q
and the Company's resale Registration Statement No. 333-26079.

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