EU awards CE mark certification to Aptima HCV Quant Dx assay for hepatitis C virus- Hologic

Hologic has been awarded EU CE Mark certification for its Aptima HCV (hepatitis C virus) Quant Dx assay on the fully automated Panther system, certified for both confirmation of active infection in patients with a positive HCV antibody result, and for viral load monitoring. The assay complements the previously certified Aptima HIV-1 Quant Dx assay, as well as women's health assays that run on the Panther system in Europe. The Aptima HCV Quant Dx assay and the Aptima HIV-1 Quant Dx assay are not yet approved for use in the US.

The Aptima HCV Quant Dx assay uses real-time transcription-mediated amplification (TMA) to test plasma or serum samples. The assay's design provides three levels of protection against mutations, and offers excellent performance across all major genotypes, with high sensitivity and precision across a wide linear range.