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

The FDA has approved Hologic's (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.

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