Massachusetts-based women's healthcare company Hologic said that the U.S. Food and Drug Administration has approved its premarket approval (PMA) applications for both the Cervista HPV HR and the Cervista HPV 16/18 tests.

The company said that Cervista HPV HR (high risk), designed to detect the 14 high-risk types of human papillomavirus (HPV) known to cause cervical cancer, is the first HPV DNA test approved by the FDA in more than 10 years.

Cervista HPV 16/18 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.

The additional approval of Cervista HPV 16/18 marks the first FDA approved HPV genotyping test available in the United States.

The HPV strains identified by this test represent the two most oncogenic and persistent types of HPV, together believed to cause approximately 70% of cervical cancer.