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 2014 FDA approval expanded the use of the cobas HPV test to include use as either a co-test or as a primary cervical cancer screening test. In April 2020, the FDA expanded its approval of the cobas HPV test for use on the fully automated high-throughput cobas 6800/8800 systems.
The cobas HPV test is approved to be used alone for primary cervical cancer screening in women aged 25 years or older. 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 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.
Although the cobas 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.
Note: The expanded use of the HPV test is now in accord with the recent change in the medical practice guidelines presented by the USPSTF and other professional organizations. (See updated guidelines described in a later section of this course).