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FDA Approves Hologic's Automated System for HPV Test

NEW YORK (GenomeWeb News) – Hologic announced after the close of the market on Thursday that it has received regulatory approval in the US of its automated system for use with the company's human papillomavirus test.

The approval from the US Food and Drug Administration is for the Cervista HTA high-throughput automation system to be used with Hologic's Cervista HPV HR test, which was approved by the agency in 2009.

The test uses Hologic's Invader technology to detect 14 high-risk types of HPV that are associated with cervical cancer and precancerous lesions.

The Cervista HTA platform automates DNA extraction and detection steps of the Cervista HPV HR test. Users can now load the instrument, walk away, and then return the next morning to see the test results, Hologic said.

Rohan Hastie, vice president and general manager of Hologic Molecular Diagnostics, said that more than 200 laboratories in the US currently run the Cervista HPV HR test, and FDA approval of the Cervista HTA system "quite simply makes us even more competitive."

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