Bio-Rad Submits Premarket Approval Application To The FDA For Its Fourth-Generation HIV Assay

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 27 Jul 2010 - 0:00 PDT

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Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, 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.

Source:
Bio-Rad Laboratories, Inc.

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