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Hologic HCV Assay Wins FDA Premarket Approval

NEW YORK (GenomeWeb) – Hologic said Wednesday that the US Food and Drug Administration has given premarket approval for use of its Aptima HCV Quant Dx assay on the automated, sample-to-answer Panther system, to quantify hepatitis C viral load and confirm active HCV infection.

In the US, the Panther menu already includes tests for HIV-1 viral load and sexually-transmitted infections that include chlamydia, gonorrhea, trichomonas, and human papillomavirus.

In Europe, the Aptima HCV and HIV-1 assays are CE-marked for diagnostic and viral load monitoring. The Aptima HBV assay is CE-marked for viral load monitoring, but is not currently approved for sale in the US, the firm said.

Hologic said that its Aptima HCV Quant Dx assay uses real-time transcription-mediated amplification to provide sensitive and specific diagnostic performance, and reliable quantitation for determination of sustained antiviral response across all major genotypes.  

The Panther system "substantially reduces hands-on time with random and continuous access," the firm added.

The approval will help physicians more quickly determine the best treatment options and help improve patient care, Tom West, president of the Diagnostic Solutions Division at Hologic, said in a statement.

"HCV therapeutic options continue to evolve rapidly with highly effective antiviral medications that are transforming treatment of the disease, with cure rates above 90 percent," he added.