Company Snapshot: BIOC  Print This Story  Email This Story  Save this Link View PR Newswire's RSS Feed  Blogs Discussing this News Release  Search Blogs that Mention this News Release  Click this link to view linked Bookmarking Services Click this link to view linked Blogging Services


Biocircuits Submits 510(k) to FDA for Marketing Clearance of Free T4 Assay

    SUNNYVALE, Calif., March 3 /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 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.


SOURCE Biocircuits Corporation




Back to Topback to top

CONTACT:
John Kaiser, President and CEO, 408-752-8706,
or James Welch, Vice President & CFO, 408-752-8728, both of
Biocircuits Corporation
CNOC: http://www.prnewswire.com or fax, 800-758-5804, ext.
113540