FDA Approves Two Hologic HPV Tests

Hologic received approval for two tests to detect human papillomavirus (HPV), the Cervista HPV HR (high risk) and Cervista HPV 16/18 tests. The Cervista HPV HR — intended to detect the 14 high-risk types of HPV known to cause cervical cancer — is the first HPV DNA test approved by the FDA in more than 10 years, according to Hologic. The Cervista HPV 16/18 is the first HPV test approved for HPV types 16 and 18, which have been associated with about 70 percent of cervical cancers in the U.S., the company added.