Bio-Rad Receives FDA Clearance for Novel Interpretive Software Used for Autoimmune Testing
16 Novembro 2005 - 11:00AM
PR Newswire (US)
Medical Decision Support Software to be Used With BioPlex(R) 2200
ANA Screen Kit HERCULES, Calif., Nov. 16 /PRNewswire-FirstCall/ --
Bio-Rad Laboratories, Inc. (Amex: BIO; BIOb) announced today that
it has received marketing clearance from the U.S. Food and Drug
Administration (FDA) for its Medical Decision Support Software
(MDSS) designed for use with the company's FDA cleared BioPlex 2200
ANA Screen and BioPlex 2200 System. This interpretive
algorithm-based software is the first product of its kind to be
FDA-cleared for the purpose of correlating patient antibody results
with specific autoimmune diseases. Using the MDSS with the BioPlex
2200 ANA Screen, autoimmune laboratories will now be able to
provide physicians with valuable information on possible disease
associations for patient antibody profiles -- information that has
never before been available through a clinical diagnostic system.
"We have been working very closely with the FDA and we are
extremely pleased to receive clearance for the BioPlex 2200 ANA
Screen and MDSS," said John Goetz, Vice President of Bio-Rad's
Clinical Diagnostics Group. "This unique collection of products
will help clinical laboratories improve their autoimmune testing
processes and further enhance the quality of service they provide
to doctors and patients." Bio-Rad's BioPlex 2200 System is the
first and only fully-automated, random access multiplex testing
system available today, providing clinical laboratories with the
technology to rapidly process, or "multiplex" multiple individual
tests, traditionally processed separately, using a single small
volume patient sample. The system is capable of generating up to
1200 autoimmune test results per hour. Also in development are
additional panels for autoimmune and infectious disease, cardiac
disease and diabetes. Bio-Rad Laboratories, Inc.
(http://www.bio-rad.com/) is a multinational manufacturer and
distributor of life science research products and clinical
diagnostics. It is based in Hercules, California, and serves
thousands of research and industry customers worldwide through a
network of more than 30 wholly owned subsidiary offices. Various
statements made within this press release may constitute
"forward-looking statements" for purposes of the Securities and
Exchange Commission's "safe harbor" provisions under the Private
Securities Litigation Reform Act of 1995 and Rule 3b-6 under the
Securities Exchange Act of 1934. The forward-looking statements
contained herein involve risks and uncertainties that could cause
results to differ materially from the Company's expectations.
DATASOURCE: Bio-Rad Laboratories, Inc. CONTACT: Ron Hutton,
Treasurer of Bio-Rad Laboratories, Inc., +1-510-724-7000, or Web
site: http://www.bio-rad.com/
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