There may be some changes coming to your routine gyno visits. Yesterday, the FDA approved a new HPV DNA test for women 25 and older, which can be used alone (without a Pap smear) to test for cervical cancer.
Last month, this testÃ¢â‚¬”called the cobas HPV TestÃ¢â‚¬”was unanimously recommended by the FDA Microbiology Devices Panel of the Medical Devices Advisory Committee. They found that the test was safe and effective at detecting high-risk types of HPV that are more likely to lead to (or indicate) cervical cancer. The test uses a sample of cervical cells to identify 14 high-risk types of HPVÃ¢â‚¬”specifically HPV 16 and HPV 18. If it detects either of these two types, it is recommended that the patient get a colposcopyÃ¢â‚¬”a more detailed exam of the cervical cells. If the test detects any of the other types of HPV, it's then recommended that you get a Pap test to see if you need a colposcopy.
So does that mean this is replacing Pap smears forever? Not exactly. In fact, this FDA approval does not change the guidelines or recommendations for Pap smears, it merely provides a third option for health care providers and patients to consider, says FDA spokeswoman Susan Laine. If you're over 25 and would prefer to use this screening method instead of your usual Pap smear, now you can.
Current guidelines recommend that women age 21-65 receive a Pap smear every three years. If the Pap test is abnormal, then you would get an HPV test. Otherwise, you wouldn't get the HPV test until age 30, at which point you can choose to get both tests at the same time every five years (rather than just the Pap test every three years). "These tests have been available for years," says Mary Jane Minkin, M.D., clinical professor of obstetrics and gynecology at Yale University School of Medicine. "They're just saying this test is now licensed to use as a stand-alone test without a Pap smear [for women 25 and older]." Essentially, you can still rely on your usual Pap test if you'd prefer.
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So why is the test now approved for women 25 and older? Previously, HPV testing was only recommended for women 30 years and older, as HPV is so prevalent and the majority of cases resolve on their own, says Minkin. After all, who wants to freak out over positive test results if they don't actually mean your health is in danger? Although several panel members did express concerns about overtreatment in the 25-29 age group, ultimately they agreed that the benefits outweigh the risks, says Laine, since patients between 25-29 years old have the highest prevalence of cervical precancer.
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That said, Minkin does worry about the impact of over-screening and the emotional or relationship stress that may come with finding out you have a type of HPVÃ¢â‚¬”especially since the vast majority of cases resolve on their own. Other experts, like Diana Zuckerman, Ph.D., president of the Cancer Prevention and Treatment Fund, share this opinion. Ultimately, it's important to speak with your physician about your options to find out which screening method is best for you. And at this point, the FDA does not have information regarding the cost of this test or how often it will be covered by insurance. "I don't think there is a right or wrong answer to say which is better," says Minkin. "But I still will not change my practice."
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