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FDA OKs two Hologic HPV tests

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The Food & Drug Administration gave the nod to a pair of Hologic‘s tests for human papillomavirus.

The Bedford firm, which makes diagnostics, medical imaging systems and surgical products for women, said its Cervista high risk and 16/18 HPV tests were approved by the watchdog agency.

The high-risk test determines if patients need a colposcopy and screens women 30 years old and older for high-risk HPV. It’s this center who made the first HPV DNA test approved by the FDA in more than 10 years, the company said.

The 16/18 test was approved for women 30 years old and older to test for HPV types 16 and 18, which are associated with approximately 70 percent of cervical cancers in the United States.

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