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Aptima HBV Quant Assay gets PMA approval

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Jan. 30, 2018Hologic announced the FDA has granted PMA approval for the Aptima HBV Quant Assay for quantitation of hepatitis B viral load on the Panther system.

The Aptima HBV Quant assay is the newest addition to the Panther system’s viral load menu, joining the previously approved Aptima HIV-1 Quant Assay and Aptima HCV Quant Dx Assay. The three assays use the company’s proprietary real-time transcription-mediated amplification, which provides highly sensitive and specific performance. The HBV Quant assay quantitates HBV DNA across all major genotypes A–H.

“This approval represents a milestone for Hologic’s growing virology assay menu,” Tom West, president of Hologic’s diagnostic solutions division, said in a statement. “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 HBV Quant assay offers a dual-target approach that aims to deliver accurate quantitation over a broad linear range and tolerates potential mutations in the HBV genome. The assay’s linear range is from 10 IU/mL to 1 billion IU/mL, which helps ensure precise quantitation for samples with the high viremia often associated with chronic HBV infection.

The Panther system can run viral load assays for HIV-1, HCV, and HBV in parallel or from a single patient sample. The Panther menu also includes tests for sexually transmitted infections including chlamydia, gonorrhea, trichomonas, human papillomavirus, and herpes simplex virus.

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