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Gen-Probe Submits HPV Assay Application to FDA

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Gen-Probe said after the close of the market Monday that it has submitted a Premarket Approval Application with the US Food and Drug Administration for its Aptima human papillomavirus assay.

The San Diego-based molecular diagnostics firm said that the new nucleic acid test can detect high-risk HPV infections that are associated with cervical cancer and precancerous lesions. Specifically, the Aptima HPV assay detects 14 high-risk HPV types that are associated with cervical cancer. It also can detect messenger RNA from two viral oncogenes, E6 and E7, which are more prevalent in the severe cervical lesions likely to progress to cervical cancer, the firm said.

If the test is cleared by FDA, it will run on Gen-Probe's Tigris molecular diagnostics instrument. It would compete with FDA-cleared molecular tests sold by Qiagen and Hologic.

"From a business perspective, this regulatory submission represents the last of five we have completed in the United States this year," Gen-Probe President and CEO Carl Hull said in a statement. "When approved, we expect these new products to start an important new sales growth cycle for the company."

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