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USPSTF Cervical Cancer Screening Recommendations Strike Compromise on Cotesting

NEW YORK (GenomeWeb) – The US Preventive Services Task Force today updated its cervical cancer screening recommendations to advise that women aged 30 to 65 may choose to get screened every three years with cervical cytology alone, every five years with high-risk HPV testing alone, or every five years with hrHPV testing in combination with cytology, also known as cotesting.

The task force also recommends that women aged 21 to 29 should get screened every three years with cervical cytology alone, also known as a Pap smear. USPSTF recommends against screening women over age 65 who have had adequate prior screening and are not otherwise at high risk for cervical cancer, or women who have had a hysterectomy with removal of the cervix and do not have a history of high-grade precancerous lesion or cervical cancer.

The recommendations represent a change from prior ones in that it introduces hrHPV testing alone as a new recommendation. According to the USPSTF, for women aged 30 to 65 cytology alone every three years or hrHPV testing every five years are the "preferred screening strategies based on USPSTF review of trial, cohort, and modeling results." The task force's 2012 recommendations advised cytology alone every three years or cotesting through hrHPV testing in combination with cytology every five years for the 30 to 65 age group.

A draft version of the updated recommendations drew controversy because for women 30 to 65 years of age it only recommended either cervical cytology alone every three years or hrHPV testing alone every five years and did not include cotesting as an option. At the time, there were five HPV tests approved for use in cotesting, but out of the five, only Roche's Cobas hrHPV was approved to be used alone for primary testing. There were concerns that the limited number of test options for hrHPV testing alone would make the recommendations difficult to implement.

USPSTF has acknowledged that concern in issuing its final recommendation.

"Several comments highlighted implementation issues due to a lack of tests approved by the US Food and Drug Administration for primary cervical cancer screening. In response to these comments, the USPSTF now notes throughout the recommendation statement that women aged 30 to 65 years may choose to get screened every three years with cervical cytology alone, every five years with hrHPV testing alone, or every five years with cotesting," the task force noted in a response to public comment section of its finalized recommendation.

In a table explaining each of the recommendations, USPSTF notes that cotesting may detect slightly more cases of cervical intraepithelial neoplasia than screening with hrHPV testing alone, but with a significant increase in the number of tests and procedures.

The increased tests and procedures resulting from cotesting "may not benefit the patient" and could have "a real cost to the health system," Lee Learman, a professor of integrated medical science at Florida Atlantic University, and Francisco Garcia, a professor of public health, obstetrics & gynecology at the University of Arizona wrote in an editorial in JAMA published alongside the recommendations.

Some physicians applauded the USPSTF for taking the broader stance of including cotesting in the final recommendation.

"I commend the USPSTF for listening to women and their healthcare providers and giving an A recommendation to the broadest number of cervical cancer screening options including cytology, HPV primary screening, and especially cotesting, also known as Pap+HPV," said Mark Spitzer, medical director of The Center for Colposcopy in Long Island and past president of the American Society for Colposcopy and Cervical Pathology.

Learman and Garcia noted in their JAMA editorial, that the USPSTF recognition of primary hrHPV testing could significantly boost efforts to further develop molecular screening methods for cervical cancer.

"By establishing the legitimacy of primary hrHPV screening, the new guidelines create a space for innovation, including the development of self-sampling approaches at home or in community settings, further development of molecular markers to enhance screening and improve diagnostic performance, and individualized risk stratification for the purpose of precisely tailoring therapeutic and surveillance recommendations," Learman and Garcia wrote.

In the months since the draft recommendations were first released, other cervical cancer screening tests have received different levels of US Food and Drug Administration approvals. Becton Dickinson's BD Onclarity HPV assay, designed for specimens collected in the BD SurePath liquid-based cytology vial, received pre-market approval in February. The test is clinically validated for use as a primary screening test, for triaging patients with abnormal Pap test results, and to be used in combination with a Pap test, BD said in a statement.

In addition, in June the FDA approved Roche's Cobas HPV test as a first-line cervical cancer screening test for women 25 and older using cervical specimens collected in Becton Dickinson's SurePath preservation fluid. The Cobas test is now approved for use as a primary screening test with SurePath and Hologic's ThinPrep PreservCyt Solution, the two liquid media used to collect samples for the vast majority of Pap or HPV tests in the US, Roche said.