FDA Approves Hologic’s HIV Viral Load Monitoring Assay

FDA granted premarket approval to a HIV-1 viral load monitoring assay developed by Hologic.

The Aptima HIV-1 Quant assay is a nucleic acid amplification test for the quantitative detection of RNA from HIV in plasma specimens, which runs on Hologic's Panther system.

The assay is not approved for HIV-1 diagnosis in the U.S. Outside the U.S., the Aptima HIV-1 Quant Dx assay is CE-IVD marked for both diagnostic and monitoring claims.

According to Hologic, the Aptima Quant viral load assays are not part of the recently announced pending sale of Hologic’s blood donor screening business to Grifols, and will continue to be owned by Hologic upon closing of the transaction.