The Food and Drug Administration has approved Hologic’s HIV-1 viral load monitoring test, the Aptima HIV-1 Quant. This assay is a nucleic acid amplification test that quantitatively detects RNA from HIV in plasma specimens. It runs on Hologic’s automated Panther system that uses a dual target approach against highly conserved regions in the HIV genome in order to cover all HIV-1 groups and subtypes. Published studies have compared the performance of the Aptima HIV-1 Quant assay with other HIV viral load monitoring tests on the market, and have demonstrated that Hologic’s assay provides repeatable, reliable results for consistent quantitation of viral load. However, although the assay is CE-marked for both diagnostic and monitoring claims outside the U.S., it is not approved for HIV-1 diagnosis in the U.S.