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FDA Grants Approval for Hologic Hepatitis B Viral Load Assay

NEW YORK (GenomeWeb) – Hologic said today that the US Food and Drug Administration has granted premarket approval for its Aptima HBV Quant Assay for quantitation of hepatitis B viral load on its fully automated Panther system.

The assay reliably quantitates HBV DNA across genotypes A-H, provides a dual-target approach that delivers accurate quantitation over a broad linear range, and tolerates potential mutations in the HBV genome, Hologic said.

The firm noted that the assay's linear range, from 10 IU/mL to 1 billion IU/mL, helps ensure precise quantitation even for samples with the high viremia often associated with chronic HBV infection.

Tom West, president of the diagnostic solutions division at Hologic, said in a statement that the approval means that the three major viral load assays that most laboratories run for patients are now available on a single system.

With the Panther system, labs can run viral load assays for HIV-1, HCV, and HBV in parallel or from a single patient sample.

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

The assay joins a previously approved Aptima HIV-1 Quant Assay for human immunodeficiency virus and Aptima HCV Quant Dx Assay for hepatitis C virus on the Panther system's viral load menu. All three assays use real-time transcription-mediated amplification, which the firm said provides highly sensitive and specific performance.

Piper Jaffray analyst William Quirk wrote in a research note today that HBV is the lowest volume of the three Hologic viral load assays but critical to the firm gaining share of the approximately $500 million US market. He noted that labs historically are resistant to change vendors without all three approvals. The investment bank believes Hologic "could transform this market much like it has in the domestic HPV and CT/NG markets," he said.

In Europe, the Aptima HBV Quant assay is CE-IVD marked for viral-load monitoring.