FDA Grants Premarket Approval for Hepatitis C Viral Load Test

The FDA granted premarket approval (PMA) for Hologic, Inc’s Aptima hepatitis C virus (HCV) Quant Dx assay.

The assay uses real-time transcription mediated amplification (TMA) to provide highly sensitive and specific performance for diagnostic use, according to a company press release. Furthermore, it provides a reliable quantitation to determine sustained antiviral response across all major genotypes and wide linear range.

The assay is run on the fully automated Panther system, which provides full sample to answer automation, and substantially reduces hands-on time with random and continuous access, the release stated.

“HCV therapeutic options continue to evolve rapidly with highly effective antiviral medications that are transforming treatment of the disease, with cure rates about 90%,” said Tom West, president of the Diagnostic Solutions Division at Hologic. “The expanded use of Aptima HCV Quant Dx assay to confirm active HCV infection in addition to viral load quantitation will help physicians more quickly determine the best treatment options and help improve patient care.”

The assay is the latest available test on the Panther system in the United States market, adding to the already growing list, according to the release.

“Menu consolidation is increasingly important to clinical laboratories in their efforts to increase efficiency of operations,” West said “Expanding the range of assays that can be run on the Panther system with offerings in virology, in addition to women’s health, will health customers reach their goals.”

The Aptima HCV Quant Dx assay is CE-IVD marked for diagnostic and viral load monitoring in Europe, as is the Aptima HIV-1 Quant Dx assay. The Aptima Quant assay is CE-IVD marked for viral load monitoring, but is not available for sale in the United States.