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FDA Grants PMA Approval for Hologic's Aptima® HIV-1 Quant Assay

January 3, 2017 8:00 AM EST

MARLBOROUGH, Mass., Jan. 3, 2017 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted PMA approval for the Company's HIV-1 viral load monitoring assay. The Aptima® HIV-1 Quant assay is a nucleic acid amplification test for the quantitative detection of RNA from HIV in plasma specimens.

The Aptima HIV-1 Quant assay runs on Hologic's Panther® system, a market-leading, integrated platform that fully automates all aspects of testing, from sample to result. The system substantially reduces hands-on time for laboratories by providing random and... More