Aptima HCV assay gets PMA approval
March 2, 2017—Hologic announced that the FDA has granted PMA approval for the company’s hepatitis C virus assay for quantitation of HCV viral load and confirming active HCV infection on the fully automated Panther system.
The Aptima HCV Quant Dx assay uses real-time transcription-mediated amplification as well as reliable quantitation for determination of sustained antiviral response across all major genotypes and a wide linear range. The assay runs on the Panther system, which provides full sample to answer automation and reduces hands-on time with random and continuous access.
In Europe, the Aptima HCV Quant Dx assay is CE-IVD marked for diagnostic and viral load monitoring.