FDA OK's Hologic's Aptima HIV-1 Quant Dx assay for HIV diagnosis

 

• The FDA has approved Hologic's (NASDAQ:HOLX) diagnostic claim for its HIV-1 (human immunodeficiency virus type 1) viral load monitoring assay.
• The Aptima HIV-1 Quant Dx assay, a molecular diagnostic test that runs on the fully automated, sample-to-result Panther system is now the first dual-claim assay for both diagnosis and viral load monitoring in U.S.
• The assay utilizes a dual target approach against highly conserved regions in the HIV genome, designed to deliver reliable, consistent qualitative and quantitative results across HIV-1 groups and subtypes.
• The Aptima HIV-1 Quant Dx assay is also CE IVD-marked for both diagnostic and viral load monitoring claims.
• https://seekingalpha.com/news/3638333-fda-oks-hologics-aptima-hivminus-1-quant-dx-assay-for-hiv-diagnosis