FDA grants premarket approval to HBV assay
Hologic Inc. announced today that the FDA has granted premarket approval to the company’s Aptima HBV Quant Assay.
The assay is designed to measure hepatitis B virus DNA across all major genotypes, according to a press release. It uses a dual-target approach for accurate quantification over a broad linear range (from 10 IC/mL to 1 billion IU/mL) and can tolerate various mutations in the HBV genome.
The Aptima HBV Quant Assay is the newest viral load assay that runs on the Panther system, which provides sample-to-result automation, the release said. It can be used in parallel with the Aptima HCV Quant Dx Assay for hepatitis C virus and the Aptima HIV-1 Quant Assay, which recently received WHO prequalification status.
“This approval represents a milestone for Hologic’s growing virology assay menu,” Tom West, president of the Diagnostic Solutions Division at Hologic Inc., said in the release. “We now have available on a single system the three major viral load assays that most laboratories are asked to run for patients.”
Other assays that run on the Panther system can test for chlamydia, gonorrhea, trichomonas, HPV and herpes simplex virus.
“We hear repeatedly from clinical laboratory customers that menu consolidation is a top priority,” West said in the release. “Offering a robust virology and women’s health menu on a single automated platform will enable them to reach their efficacy goals.”
Disclosure: West is an employee of Hologic Inc.