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Bio-Rad Laboratories, Inc. (BIO) Submits Premarket Approval Application to the FDA for Its Fourth-Generation HIV Assay



7/26/2010 9:18:54 AM

HERCULES, CA--(Marketwire - July 26, 2010) - Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, today announced that it has submitted a Premarket Approval application to the U.S. Food and Drug Administration for its fourth-generation HIV assay, the GS HIV Combo Ag/Ab EIA (enzyme immunoassay).

The GS HIV Combo Ag/Ab EIA detects HIV antigens (proteins that are part of the HIV virus) and HIV antibodies (proteins that are produced by the body to fight the HIV infection), offering early detection of HIV infections as well as acute HIV infections. Clinical studies were performed at five major institutions in the United States on a large sample population including adult and pediatric patients with HIV infections, individuals in high and low risk groups, and pregnant women.

"The rate of acute HIV infections continues to increase in the United States and around the world," said John Goetz, Bio-Rad Vice President and Group Manager Clinical Diagnostics. "We look forward to being able to offer this assay in the U.S. as it is able to detect a significant number of additional cases of acute HIV infections compared to HIV antibody testing alone."

About GS HIV Combo Ag/Ab EIA Assay
The GS HIV Combo Ag/Ab EIA is an enzyme immunoassay used for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma. The assay is intended to be used as an aid in the diagnosis of infection with HIV-1 and HIV-2.

About Bio-Rad
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B) has remained at the center of scientific discovery for more than 50 years, manufacturing and distributing a broad range of products for the life science research and clinical diagnostics markets. The company is renowned worldwide among hospitals, universities, major research institutions, as well as biotechnology and pharmaceutical companies for its commitment to quality and customer service. Founded in 1952, Bio-Rad is headquartered in Hercules, California, and serves more than 85,000 research and industry customers worldwide through its global network of operations. The company employs over 6,900 people globally and had revenues of nearly $1.8 billion in 2009. For more information, please visit www.bio-rad.com.

This release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally can be identified by the use of forward-looking terminology such as, "believe," "expect," "may," "will," "intend," "estimate," "continue," or similar expressions or the negative of those terms or expressions. Such statements involve risks and uncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. For further information regarding the Company's risks and uncertainties, please refer to the "Risk Factors" in the Company's public reports filed with the Securities and Exchange Commission, including the Company's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company cautions you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. Bio-Rad Laboratories, Inc., disclaims any obligation to update these forward-looking statements.


For more information, contact:
Bio-Rad Laboratories, Inc.
Tina Cuccia
Corporate Communications
510-724-7000
Email Contact


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