Goodbye Pap Smear? Hello HPV Test
A new HPV test could now be considered the first step in detecting cervical cancer, per the recommendations of an FDA advisory committee, and can be used before or instead of a Pap test.
In three separate votes, the FDA’s Medical Devices Advisory Committee Microbiology Panel unanimously concluded that the cobas HPV (Roche Molecular Diagnostics) test is safe and effective as a stand-alone screening for cervical cancer risk in women aged 25 or older. Note: The FDA is not required to follow the recommendations of the advisory panel.
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Roche was looking to the FDA to approve cobas HPV as a first-line diagnostic tool. The test works by detecting DNA of human papillomavirus—which is the cause for almost all cases of cervical cancer.
Currently, the cobas HPV test is approved for use in women aged 21 or older as a follow-up screening after an abnormal Pap test. It is also used as a co-test, in addition to the Pap test, to screen for the high-risk HPV16 and 18 strains in women aged 30 to 65.
According to Roche, the cobas HPV test can screen for a variety of high-risk strains of HPV and determine whether a colposcopy is needed.
- Women who test positive for HPV16 or 18 will then need a colposcopy.
- Women who test negative for HPV16 or 18 but positive for other high-risk strains will need a Pap test to determine need for a colposcopy.
- Women who test completely negative will follow their physician’s recommendations.
Current US guidelines recommend that women aged 21-29 undergo Pap testing every 3 years and women aged 30-65 under go Pap testing every 3 years or both the Pap test and the HPV test every 5 years.
FDA panel recommends HPV test as a replacement for Pap smear. 2014 Mar 13. MedlinePlus. Available at: http://www.nlm.nih.gov/medlineplus/news/fullstory_145075.html. Accessed March 14, 2014.