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FDA approves two new HPV tests

Category: Sexually Transmitted Diseases

The Food and Drug Administration has given premarket approval to two new human papillomavirus (HPV) tests manufactured by Hologic, the company announced.

Cervista HPV HR (high risk) is the first pre-market approved DNA test intended to detect the 14 high-risk strains of the virus known to cause cervical cancer. The Cervista HPV 16/18 tests are designed to detect types 16 and 18 of the virus, which are thought to be responsible for 70 percent of cervical cancers.

Both tests were granted premarket approval by the government drug oversight agency for screening women over 30 years of age to detect the presence or absence of high-risk HPV strains.

Hologic said test results, along with a physician's assessment of cytology history and other risk factors may be used to guide patient treatment.

"We are extremely excited to enter this market with such a unique and strong portfolio of FDA approved molecular tests for HPV DNA," said Jack Cumming, chairman and chief executive officer of Hologic. "Our state-of-the-art Cervista HPV tests individually and in combination are designed to provide significant advantages over the existing technology and should help solidify our leadership in cervical cancer screening."

Both tests are approved for use with samples from the ThinPrep Pap Test, offering additional convenience, the company said.

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