Assay for Quantitation of Hepatitis B Viral Load Receives PMA Approval by FDA

The US Food and Drug Administration (FDA) has approved a premarket approval application (PMA) for Hologic’s Aptima HBV Quant Assay for the quantitation of hepatitis B viral load on the company’s Panther system.

The World Health Organization estimates that a staggering 257 million individuals living with hepatitis B virus; in 2015, there were 887,000 deaths associated with the virus, mostly due to cirrhosis and hepatocellular carcinoma.

The new assay offers accurate quantitation over a broad linear range—from 10 IU/mL to 1 billion IU/mL—and “tolerates potential mutations in the HBV genome,” according to the press release.

“The approval represents a milestone for Hologic’s growing virology assay menu,” Tom West, president of Hologic’s Diagnostic Solutions division, said in the press release. The other 2 assays that have been previously approved are the Aptima HIV-1 Quant Assay and the Aptima HCV Quant Assay.

All the assays use “proprietary real-time transcription-mediated amplification which provides highly sensitive and specific performance.” The newest addition, the HBV Quant Assay, quantitates HBV DNA across all major genotypes A-H.

The assays run on the company’s Panther system, which is a fully-automated platform that provides “sample-to-result automation and substantially reduces hands-on time with random and continuous access.” With the system, those working in the laboratory are able to run viral load assays for HIV-1, hepatitis C, and hepatitis B using a single patient sample or in parallel.

“We now have available on a single system the 3 major load assays that most laboratories are asked to run for patients,” West said in the press release.

These are not the only tests that are available on the Panther System for infectious diseases. Chlamydia, gonorrhea, trichomonas, human papillomavirus, and herpes simplex virus, are all on the menu.