HealthDay News — The FDA has approved the first human papillomavirus (HPV) DNA test for women aged 25 years and older that can be used to assess the need for a woman to undergo additional diagnostic testing for cervical cancer.
The cobas HPV Test uses cervical cell samples to specifically identify HPV types 16 and 18, the two types responsible for approximately 70% of cervical cancers, and also detects 12 other types of high-risk HPVs at the same time.
In addition, the test can provide information about a patient’s future risk for developing cervical cancer.
Women who test positive for HPV 16 or 18 should have a colposcopy, and women testing positive for at least one of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy.
Other information should be used by health care professionals in conjunction with the cobas HPV Test results, including the patient’s screening history and risk factors, as well as current professional guidelines.
The cobas HPV Test’s safety and effectiveness were evaluated in a study of more than 40,000 women 25 years and older who underwent routine cervical exams. Women who had a positive Pap test or whose cervical cells screened positive for HPV, as well as a subset of women whose Pap and HPV tests were both negative, underwent a colposcopy and cervical tissue biopsy
The biopsy results were compared to the Pap and cobas HPV Test results. Results from this study, including three-year follow-up data indicated that the cobas HPV Test was safe and effective for use as a primary screening tool for cervical cancer.
The cobas HPV Test is manufactured by Roche Molecular Systems Inc., based in Pleasanton, Calif.