Abbott Submits New HIV Test to FDA for Expedited Review

An assay to aid in the early detection of HIV infection may soon be available in the United States. Abbott announced today it has submitted a Premarket Approval application for the ARCHITECT HIV Ag/Ab Combo assay to the U.S. Food and Drug Administration (FDA) for expedited review. Upon approval, the assay is expected to be the first test available in the United States to simultaneously detect the combined presence of HIV antigens (proteins produced by the HIV virus) and antibodies (proteins produced by the body to fight HIV antigens), which would allow for the early detection and ongoing monitoring of the virus.

Source: Abbott