Hologic announced that the U.S. Food and Drug Administration (FDA) has approved a diagnostic claim for its HIV-1 (human immunodeficiency virus type 1) viral load monitoring assay.
According to Hologic, the Aptima HIV-1 Quant Dx assay is now the first dual-claim assay for both diagnosis and viral load monitoring in the United States.
The AptimaHIV-1 Quant Dx assay, which was approved in late 2016 for viral load monitoring, is a molecular diagnostic test that runs on the fully automated, sample-to-result Panther system. The assay utilizes a dual target approach against highly conserved regions in the HIV genome that is 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.
There are approximately 1.2 million people living in the United States with HIV, with 38,000 new infections in 2018.1
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