FDA OK's new claim for Hologic's HIV assay

2019 02 13 19 24 5396 Fda Logo V2 400

The U.S. Food and Drug Administration (FDA) has approved Hologic's diagnostic claim for its HIV-1 viral load monitoring assay, the Aptima HIV-1 Quant Dx assay.

The Aptima HIV-1 Quant Dx is now the first dual-claim assay for both diagnosis and viral load monitoring in the U.S., Hologic said. First approved in late 2016 for viral load monitoring, the assay is a molecular diagnostic test that runs on the automated, sample-to-result Panther system. It uses a dual target approach against highly conserved regions in the HIV genome designed to deliver results across HIV-1 groups and subtypes, Hologic said.

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