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Hologic Gets CE Mark for HIV Viral Load Assay

NEW YORK (GenomeWeb) – Hologic today said that it has received the CE mark for its Aptima HIV-1 Quant Dx assay for use on its Panther molecular diagnostics system.

The new assay uses Hologic's real-time transcription-mediated amplification technology, and its launch in Europe marks the firm's entry into the viral load market. According to the company, the Aptima HIV-1 Quant Dx assay is the first viral load assay with a dual claim for diagnosis and treatment monitoring.

"The availability of this new assay on the Panther system eases the burden of laborious manual sample preparation, frees laboratories from batching restrictions required by older systems, and helps low- to high-volume laboratories streamline workflow," Tom West, division president, diagnostics division of Hologic, said in a statement. "The Aptima HIV-1 Quant Dx assay sets a new benchmark for manufacturers of viral load assays and is the first in a line of viral load offerings that the company expects to introduce including assays for hepatitis C and hepatitis B."

Hologic noted that the Aptima HIV-1 Quant Dx assay is not yet approved for use in the US.