Cancer Treatment Centers of America

FDA approves HPV DNA test for cervical cancer screening

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Last week, the Food and Drug Administration approved an HPV DNA test for women 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, as well as the risk for developing cervical cancer in the future.

My reaction to the announcement was a combination of hope and caution, as up to this point there has not been a reliable, safe and inexpensive alternative to the Pap smear to test for cervical cancer. In addition, this announcement surely will raise many questions in women’s minds about the use of this test.

  1. Does this new DNA test replace my regular Pap smear test?

    No. The Pap smear is still a vital component for cervical cancer prevention. FDA approval simply means that the HPV test has been proven safe and effective. Currently, guidelines are being updated to reflect the optimal use of the HPV test. Until new guidelines are issued, however, the HPV test should be used for women with an inconclusive Pap test or as part of a Pap test (co-testing) in women over age 30. It should be noted that the Pap smear test has a long history of reliability and has played a key role in reducing the rate of cervical cancer by 50 percent over the last 30 years. Get the facts about HPV.

  2. How do I know if this test is appropriate for me?

    Right now, it’s too early to tell how the new application of this test will be used, however we know the HPV DNA test is safe (it was approved for follow up testing in 2011). Currently, the Pap smear test is the most effective diagnostic tool doctors have to identify women at risk of cervical cancer. The new test is for women over age 25 and should be used with other information such as family history and other risk factors, to assess whether a woman is at risk for cervical cancer. As with many new diagnostic tools there is concern that expanded use of the HPV screening test could lead to over-testing, more health care costs and unnecessary tests. HPV: To vaccinate or not to vaccinate?

  3. How much does the new test cost?

    The new DNA test will cost approximately twice as much as a Pap smear, or about $80 to $100.

  4. If I get this new test and it comes up positive, what then?

    Some doctors are looking at this test as sort of a chicken and egg quandary—which test should come first: the Pap or the HPV screening test? A woman who tests positive for HPV 16 or HPV 18 should have a colposcopy, an exam using a device that illuminates and magnifies the cervix so 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, thus the chicken-egg quandary. Essentially, the HPV screening test should be viewed as one of the diagnostic tools available to screen for cervical cancer, not the only tool.

My recommendation is to continue to talk with your healthcare provider during your annual exams to ensure that you are getting properly screened for cervical cancer, because early detection is truly crucial to fighting cervical cancer.

Learn more about diagnostic testing for cervical cancer.

Read another blog post by Dr. Chura about the HPV vaccine.