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Gen-Probe Submits PMA to FDA for HPV Assay

NEW YORK (GenomeWeb News) – Gen-Probe has submitted an application with the US Food and Drug Administration for regulatory approval of a genotyping assay for human papillomavirus.

A spokesman for the San Diego-based company today confirmed the PMA submission. The assay will run on the Tigris system and will detect for type 16 alone and type 18/45 together. The spokesman declined to comment about when a decision from FDA is expected.

FDA cleared Gen-Probe's Aptima HPV assay in the fall for the detection of 14 high-risk HPV types associated with cervical cancer and precancerous lesions.

Brian Weinstein, an analyst at investment bank William Blair, said in a research note today that the assay will be an important addition to Gen-Probe's product line as buzz about genotyping grows.