FDA approval for Hologic’s Aptima

MARLBOROUGH, Mass.—Late January brought news from Hologic Inc. that the U.S. Food and Drug Administration had granted pre-market approval (PMA) for the Aptima HBV Quant Assay for quantitation of hepatitis B viral load on the fully automated Panther system.

The Aptima HBV Quant assay represents the newest addition to the Panther system’s viral load menu, joining the previously approved Aptima HIV-1 Quant Assay (for human immunodeficiency virus) and Aptima HCV Quant Dx Assay (for hepatitis C virus). All three new assays use Hologic’s proprietary real-time transcription-mediated amplification, which provides highly sensitive and specific performance. The HBV Quant assay is said to reliably quantitate HBV DNA across all major genotypes A-H.

“This approval represents a milestone for Hologic’s growing virology assay menu,” said Tom West, president of the Diagnostic Solutions division at Hologic. “We now have available on a single system the three major viral load assays that most laboratories are asked to run for patients.”

The Aptima assays run on the Panther system, which provides full, sample-to-result automation and substantially reduces hands-on time with random and continuous access. With the Panther system, laboratorians can now run viral load assays for HIV-1, HCV and HBV in parallel, or even from a single patient sample.

According to the company, the Aptima HBV Quant assay offers “a unique, dual-target approach that delivers accurate quantitation over a broad linear range and tolerates potential mutations in the HBV genome. The Aptima HBV Quant assay’s linear range is one of the broadest on the market (from 10 IU/mL to 1 billion IU/mL). This helps ensure precise quantitation even for samples with the high viremia often associated with chronic HBV infection.”

The HBV assay joins a growing menu of tests available on the Panther system in the U.S. market. In addition to the three viral load assays, the Panther menu includes tests for sexually transmitted infections including chlamydia, gonorrhea, trichomonas, human papillomavirus and herpes simplex virus.

“We hear repeatedly from clinical laboratory customers that menu consolidation is a top priority,” said West. “Offering a robust virology and women’s health menu on a single automated platform will enable them to reach their efficiency goals.”