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FDA OKs Hologic HPV Assays

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing Hologic's two assays for human papillomavirus testing, making it the second firm to gain FDA clearance to sell a molecular diagnostic for the condition in the US.

The Bedford, Mass.-based firm received FDA OK for its Cervista HPV HR (high risk) and Cervista HPV 16/18 tests. The HR test is designed to detect the 14 high-risk types of HPV known to cause cervical cancer, while the 16/18 test is the first HPV test approved for genotyping for HPV types 16 and 18, known to be associated with approximately 70% of all cervical cancers in the United States.

Hologic becomes the second company to have regulatory approval to sell an HPV molecular diagnostic test in the US, following Qiagen, which gained the test through its 2007 acquisition of Digene.

Holgic said that the Cervista HPV HR test includes an internal control to verify adequate cellularity for testing, which should reduce the potential for false negative results. The firm also noted that it requires a smaller specimen volume that may minimize inconclusive or indeterminate results, which may lead to fewer patients being called back for repeat testing.

In a research note published this morning, Thomas Weisel Partners analyst Peter Lawson said that he expects the final labeling for the HR test will show comparable performance to Qiagen's test.

"We believe, while competition is increasing, the HPV marketplace is significantly large and underpenetrated, allowing for multiple players to be successful," he wrote. "The US market is around 25 percent penetrated, while penetration in Europe and Asia are in the single digits. The largest driver for the market could occur should the HPV test supplant the Pap as the primary screen, which could occur in smaller European countries in the near future, though widespread adoption is probably years away."

In Friday afternoon trading on the Nasdaq, Hologic's shares were up 11 percent at $11.73, while Qiagen's shares were down 7 percent at $15.08.

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