Women’s healthcare company Hologic received FDA premarket approval for Cervista HPV HR test and the Cervista HPV 16/18 test. The tests are manufactured by Third Wave Technologies. The high-risk Cervista HPV HR test has been approved to screen patients with atypical squamous cells of undetermined significance from cervical cytology results and determine the need for referral to colposcopy. It can also be used adjunctively with cervical cytology to screen women 30 years and older to assess the presence or absence of high-risk HPV types.
The Cervista HPV 16/18 test has been OKed for use 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.
However, the results of this test are not intended to prevent women from proceeding to colposcopy.
“Results from these two tests, when considered with a physician’s assessment of the patient’s history, other risk factors, and professional guidelines, can help physicians better determine risk and could lead to better patient management,” said Daniel G. Schultz, MD, director of the FDA’s Center for Devices and Radiological Health.
HPV is the most common sexually transmitted infection in the U.S., effecting six million people a year.