Bio-Rad Receives FDA Approval for New HIV-1/HIV-2 Rapid Test

Bio-Rad Receives FDA Approval for New HIV-1/HIV-2 Rapid Test
First FDA-Approved Single Use Test Available in the U.S. to Differentiate
Between HIV-1 and HIV-2 Antibodies 


HERCULES, Calif., Jan. 4  /PRNewswire-FirstCall/ -- Bio-Rad Laboratories, Inc.
(Amex: BIO; BIOb), a multinational manufacturer and distributor of life science
research products and clinical diagnostics, announced today that it recently
received approval from the U.S. Food and Drug Administration (FDA) for its new
Multispot HIV-1/HIV-2 Rapid Test. This highly sensitive test kit will soon be
available in the United States and will significantly aid in the diagnosis of
HIV-1/HIV-2 (Human Immunodeficiency Virus, Types 1 and 2), the viruses that
cause AIDS (Acquired Immunodeficiency Syndrome).

"This unique rapid test is the only single use assay to be approved by the FDA
for the detection and differentiation of HIV-1 and HIV-2 antibodies," said John
Goetz, Bio-Rad Vice President and Group Manager of Clinical Diagnostics. "We
are pleased to receive FDA approval and look forward to providing the product
to our U.S. customers in January 2005.

The Multispot HIV-1/HIV-2 Rapid Test is an important addition to the company's
HIV product line, which now includes a full range of kits for screening,
confirmation and differentiation of HIV-1 and HIV-2 antibodies. The new single
use qualitative enzyme immunoassay can be used on both fresh and frozen serum
and plasma samples; it is easy to use, producing results in approximately 10
minutes; and it will provide clinical laboratories with a significant
improvement to existing diagnostics for HIV. Clinical studies on a large number
of HIV-1 and HIV-2 antibody positive and negative samples have shown that the
test provides the highest levels of sensitivity (100%) and specificity
(>99.9%). The assay is also suitable for use in multi-test algorithms designed
for statistical validation of rapid HIV test results. The test is moderately
complex and approved for use in CLIA-certified laboratories (Clinical
Laboratory Improvement Amendments of 1988).

The U.S. Centers for Disease Control and Prevention (CDC) recently reported
that there are between 850,000-950,000 people living with HIV/AIDS in the U.S.
alone. Due to the disproportionate number of cases of people who do not know
they are infected (people who are tested, but do not return for results), the
CDC and other World Health Organization (WHO) affiliates are showing increased
support for the implementation of rapid HIV testing programs that will provide
patients with faster test results. According to WHO, testing and counseling is
the key entry point to prevention services in populations at risk for HIV/AIDS
and can lead to the reduction of infections transmitted sexually and/or by
intravenous drug use.

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 more than 70,000
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:  Susan Berg, Corporate Communications, of Bio-Rad Laboratories,

Inc., [phone], or 



Web site:  http://www.bio-rad.com/ 

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