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Aptima HIV-1 Quant assay gets PMA approval

Jan. 12, 2017—The Food and Drug Administration has granted PMA approval for Hologic’s HIV-1 viral load monitoring assay. The Aptima HIV-1 Quant assay, which runs on the company’s Panther system, is a nucleic acid amplification test for the quantitative detection of RNA from HIV in plasma specimens.

“Clinical laboratories have an increasing need to consolidate testing onto automated instruments,” Tom West, president, Diagnostic Solutions Division at Hologic, said in a company statement. “Adding HIV viral load monitoring to our existing women’s health menu allows customers to maximize use of the widely adopted, reliable, and user-friendly Panther system.”

The Aptima HIV-1 Quant assay is not approved for HIV-1 diagnosis in the United States. Outside the U.S., the Aptima HIV-1 Quant Dx assay is CE-IVD marked for diagnostic and monitoring claims.

The Aptima Quant viral load assays are not part of the recently announced pending sale of Hologic’s blood donor screening business to Grifols, and the assays will continue to be owned by Hologic upon closing of the transaction with Grifols.

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