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FDA Approves First HPV Test for Primary Cervical Cancer Screening
The FDA has given the green light to the first agency-approved human papillomavirus (HPV) DNA test for women 25 years of age and older that can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can provide information about the patient’s risk of developing cervical cancer in the future.
Using a sample of cervical cells, the cobas HPV test (Roche Molecular Systems, Inc.) 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.
Women who test positive for HPV 16 or HPV 18 should have a colposcopy — an exam using a device that illuminates and magnifies the cervix so that a physician can directly observe the cervical cells. 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. Health care professionals should use the cobas HPV test results together with other information, such as the patient screening history and risk factors, and current professional guidelines, the FDA says.
The FDA originally approved the cobas HPV test in 2011 for use in conjunction with or as a follow-up to a Pap test (cell cytology), which examines cervical cells for changes that might become cervical cancer.
The new approval expands the test’s indication to include use as either a co-test or a primary cervical cancer screening test; however, it does not change current medical 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. According to the Centers for Disease Control and Prevention (CDC), they 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 resolves on its own and does not cause any health problems. However, about 10% of women infected with a high-risk HPV develop a persistent infection, which may put them at risk of developing cancer. Virtually all cervical cancers are caused by HPV infections. However, just two types — HPV 16 and HPV 18 — are responsible for approximately 70% of these 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 25 years of age and older undergoing routine cervical examinations. 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 with the Pap and cobas HPV test results. Data from this study, which included 3 years of follow-up in women who underwent colposcopy, showed that the cobas HPV test is safe and effective for its new indication.
Source: FDA; April 24, 2014.