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    Is HPV testing ready for ‘prime’ time in cervical cancer detection?


    While current screening guidelines remain unchanged, patients and physicians will now have the ability to choose the cobas HPV test over current screening methods. I believe that this will add confusion to an already complicated screening process, may result in unnecessary procedures in women between ages 25 and 30, and may miss detection of non-HPV cervical cancers.

    These recommendations were largely based on the results of the ATHENA trial that tested 47,000 women and compared HPV testing to cytology as a screening option.2 The trial has several weaknesses. First, CIN2/3 was used as a surrogate for invasive cervical cancer in the trial. Based on different studies, the rate of spontaneous regression of these lesions varies from 6% to 50%. Thus, using CIN2/3 as a surrogate for invasive cervical cancer is likely overestimating the rate of detection. In addition, the quality of the cytology used in the trial varied widely with below-average abnormal cytology rates reported among the patients tested. Sensitivity for >CIN3 was only 58% in the trial,3 whereas the reported rate in our laboratory and others for significant cervical neoplastic disease approaches 93%; this is a quality control issue that was not addressed in the trial. More importantly, about 4% of cervical cancer cases are not HPV-related at all and about 10% of patients with invasive cervical cancer will test negative for HPV.3 These data underscore the importance of using HPV typing as an adjunct and not as a replacement for screening cytology.

    In fact, data from Kaiser Permanente show that 5-year cumulative cervical cancer incidence is lowest with conventional Pap and HPV cotesting as compared to either method used alone.4 Using data from the largest laboratory pathology database in the United States, Quest Diagnostics issued a statement to the FDA that primary screening with HPV testing alone could miss 13.5% of cervical cancers that would normally be identified with cotesting. Finally, the FDA approval allows HPV testing in women ages 25 to 30, a group not covered under current screening guidelines. There are currently no data to support routine HPV testing in women in this age group, given their high rate of spontaneous clearance of the virus.


    Sarah Feldman, MD, MPH
    Dr. Feldman is Associate Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School, Director of Ambulatory ...
    Aparna Kamat, MD
    Dr. Kamat is the Director of Gynecologic Oncology in the Department of Obstetrics and Gynecology at the Methodist Hospital, Houston, Texas.


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