On April 24, 2014 the FDA approved the cobas HPV test as the first HPV DNA-based test for primary cervical cancer screening. The test, manufactured by Roche Molecular Systems of Pleasanton, CA is the same HPV test (cobas HPV Test) given FDA approval in 2011. The FDA approval granted in 2011 was for use in conjunction with or as a follow-up to a Pap test. The new FDA approval now expands the use of the cobas HPV test to include use as either a co-test or as a primary cervical cancer screening test.The expanded use of the HPV test does not at this time change the current medical practice guidelines presented by the various professional organizations.
In the FDA application for the test, supporting data was included on the use of the cobas HPV test as a primary screening test for cervical cancer. The data included a study of more than 40,000 women 25 years and older undergoing 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. All biopsy results were compared to the Pap and cobas HPV Test results. Data from this study, which included three years of follow-up on women who went on to colposcopy, showed that the cobas HPV Test is safe and effective for the new indicated use.
The expanded FDA approval allows for the test to be used instead of the Pap test to screen for cervical cancer in women 25 years old and older. According to the approval, women who test positive for HPV 16 or 18 should have a colposcopy, while women who test positive for one of the other high-risk HPV types should have a Pap test to determine if a colposcopy is needed.
The expanded approval that allows for the test to be used instead of the Pap test to screen for cervical cancer does conflict with current professional practice guidelines, which call for the HPV test as a follow-up test for patients aged 21 and older with abnormal cervical cytology and as an adjunct test to Pap in women 30 years and older. Moreover, professional organizations' opinions are somewhat divided about the use of the HPV test as a primary screening test. Although the HPV test has greater sensitivity than the Pap test (approximately 90 percent versus 50 percent), Pap testing is still widely used in clinical practice and is considered the largest volume of testing in the anatomic pathology sector.