A Medical Device Daily
Hologic (Bedford, Massachusetts) said the FDA has approved the company's premarket approval (PMA) applications for both the Cervista HPV HR (high risk) and the Cervista HPV 16/18 tests. Cervista HPV HR is designed to detect the 14 high-risk types of human papillomavirus (HPV) known to cause cervical cancer. The Cervista HPV 16/18 is used in genotyping for HPV types 16 and 18.
The Cervista HPV HR test has been approved for two uses: To screen patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy; and to be used adjunctively with cervical cytology to screen women 30 and older to assess the presence or absence of high-risk HPV types.
The Cervista HPV 16/18 test also has been approved for two uses: In women 30 years and older the test may be used adjunctively with the Cervista HPV HR test in combination with cervical cytology to assess the presence or absence of specific high-risk HPV types; and to be used adjunctively with the Cervista HPV HR test in patients with ASC-US cervical cytology results, to assess the presence or absence of specific high-risk HPV types. The results of this test are not intended to prevent women from proceeding to colposcopy.
Hologic makes diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women.