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    FDA approves HPV test for first-line screening


    Contemporary OB/GYN editorial board member Ilana Cass, MD, offers perspective on the recent FDA approval of the first-ever alternative to Pap smear cytology cervical screening.

    "The Food and Drug Administration has approved the cobas HPV test as first-line testing for cervical cancer screening in women ages 25 and older. The significance of this approval is that HPV testing would be the first-ever alternative to Pap smear cytology cervical screening.  The endorsement was based upon results from the ATHENA study, which showed that HPV testing was more sensitive in identifying cervical intraepithelial neoplasia-3 (CIN-3) when compared to liquid-based Pap smear cytology. The ATHENA trial is the largest HPV screening trial in the United States with almost 41, 000 women aged 25 or older, although final results of the ATHENA trial have not yet been published. The FDA approval of primary HPV testing means that primary HPV testing is considered a safe and effective option to screen women for cervical cancer, but the FDA approval does not issue guidelines about the use of a test or change current screening recommendations. Organizations such as SGO, ACOG and the ASCCP are currently working to develop interim guidelines to determine how primary HPV testing will be incorporated into cervical cancer screening."

    Susan C. Olmstead
    Ms. Olmstead is the Editorial Director of Contemporary OB/GYN.


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    • MischaKramer
      Thanks a lot for sharing this post. We are very pleased that the FDA has approved this test for first-line use in cervical cancer screening. It is a recognition for the value the cobas HPV Test provides to physicians and women to make more informed decisions that can ultimately prevent cervical cancer development. -Mischa Kramer
      The fact remains that, in 28 years of private practice, I have only seen TWO cases of invasive squamous Cervical Cancer, where neither woman had undergone any type of exam in at least eight years. Given that there is no current method of eradicating the virus once it has taken hold what are we trying to accomplish? The prevention of invasive disease, not early, possibly non-progressive viral changes.
      I disagree heartily withn this recommendation. While HPV HR testing may identify more cases of CIN III it will also lead to far more interventions, given the number of affected women with the virus who have no or minimal dysplastic changes. When these women undergo the requisite colposcopic biopsies what will be their follow-up, given that a healthy proportion will be persistently positive? A pap? A repeat colposcopy at what interval?


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