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Hologic Gains CE Mark for Aptima HCV Assay

NEW YORK (GenomeWeb) – Hologic today announced it has earned CE-IVD certification for its Aptima hepatitis C virus (HCV) Quant Dx assay.

The transcription-mediated amplification-based assay, which runs on the Panther system, is certified both to confirm active infection in patients with a positive antibody result and to monitor viral load. The firm said in a statement that the assay's limit of detection is 4.3 IU/mL in plasma and 3.9 IU/mL in serum, and its lower limit of quantitation is 10 IU/mL.

In December 2014, Hologic's Aptima HIV-1 assay received the CE Mark. The firm noted that its Aptima HCV and HIV-1 assays are not approved for use in the US.