Bio-Rad Receives FDA Premarket Application Approval for Its Fourth-Generation HIV Assay

Bio-Rad Laboratories, Inc. BIO and 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. 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.