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



7/25/2011 8:33:08 AM

HERCULES, CA--(Marketwire - July 25, 2011) - 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 received Premarket Application approval from the U.S. Food and Drug Administration for Bio-Rad's 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, including 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 in high and low risk populations.

According to the most recent information published by the U.S. Centers for Disease Control, "more than one million people are living with HIV in the United States. One in five (21%) of those people living with HIV is unaware of their infection. An estimated 56,300 Americans become infected with HIV each year." Early detection of HIV leads to early treatment and helps prevent new infections of the virus.

"Bio-Rad is pleased to offer its fourth-generation HIV assay in the U.S.," said John Goetz, Bio-Rad Vice President and Group Manager of Clinical Diagnostics. "Detecting HIV antigens and HIV antibodies in the same test provides clinicians with the ability to detect the virus at an earlier stage. This results in faster diagnosis of HIV-infected individuals so they are able to get the treatment they need more quickly. Bio-Rad has a long history of providing laboratories the tools that they need for HIV detection. We will continue to remain in the forefront of this critical area."

About the GS HIV Combo Ag/Ab EIA Assay
The GS HIV Combo Ag/Ab EIA is an enzyme immunoassay kit for the simultaneous qualitative detection of Human Immunodeficiency Virus (HIV) p24 antigen and antibodies to HIV Type 1 (HIV-1 groups M and O) and HIV Type 2 (HIV-2) in human serum or plasma. The kit is intended to be used as an aid in the diagnosis of infection of HIV-1 and/or HIV-2 in adults and children as young as two years of age. The kit can run on Bio-Rad's EVOLIS™ system, a self-contained automated microplate processor, and the kits may also be used with manual testing systems.

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 diagnostic 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 100,000 research and industry customers worldwide through its global network of operations. The Company employs over 6,800 people globally and had revenues exceeding $1.9 billion in 2010. For more information, 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, please contact:
Bio-Rad Laboratories, Inc.
Tina Cuccia
Corporate Communications
510-724-7000
Email Contact


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