The Food and Drug Administration for the first time has approved a DNA test for women ages 25 and older that can be used alone to help a healthcare professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer.
The test also can provide information about the patients risk for developing cervical cancer in the future, according to an FDA news release.
Using a sample of cervical cells, the cobas HPV Test detects DNA from 14 high-risk HPV types. The test specifically identifies HPV 16 and HPV 18, while concurrently detecting 12 other types of high-risk HPVs.
Based on results of the cobas HPV Test, women who test positive for HPV 16 or HPV 18 should have a colposcopy, according to the FDA. Women testing positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy. Healthcare professionals should use the cobas HPV Test results together with other information, such as the patient’s screening history and risk factors, and current professional guidelines.
Todays approval offers women and physicians a new option for cervical cancer screening, Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDAs Center for Devices and Radiological Health, said in the news release. Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer.
The FDA first approved the cobas HPV Test in 2011 for use in conjunction with or as a follow-up to a Pap test. The most recent approval expands the use of the test to include use as either a co-test or as a primary cervical cancer screening test. However, it does not change current practice guidelines for cervical cancer screening. These guidelines are developed, reviewed and modified by groups other than the FDA.
Genital HPVs are a group of more than 40 related viruses and, according to the CDC, are the most common sexually transmitted infections. Approximately 14 high-risk HPV types are associated with cervical cancer.
In most cases, a high-risk HPV infection goes away on its own and does not cause any health problems. However, about 10% of women infected with high-risk HPV develop a persistent infection that may put them at risk of cancer. Virtually all cervical cancers are caused by HPV infections, with two types, HPV 16 and HPV 18, responsible for approximately 70% of cervical cancers.
Data supporting the use of the cobas HPV Test as a primary screening test for cervical cancer included a study of more than 40,000 women ages 25 and older who were 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 to colposcopy, showed the cobas HPV Test is safe and effective for the new indication for use, according to the FDA.
The cobas HPV Test is manufactured by Roche Molecular Systems, Inc., Pleasanton, Calif.