New Guidance Recommends HPV DNA Test for Primary Screening

Laurie Barclay, MD

January 09, 2015

Primary screening for human papilloma virus (HPV) using a DNA test can be considered as an alternative to current US cytology-based cervical cancer screening strategies, according to new interim guidance from multiple societies published online January 7 in Gynecologic Oncology.

"HPV screening is highly sensitive, but specificity depends on subsequent evaluation strategies and screening frequencies," write Warner K. Huh, MD, from the University of Alabama at Birmingham, and colleagues. "[US Food and Drug Administration] approval does not include specific recommendations for applying HPV screening in the US."

The interim guidance targets clinicians considering primary HPV testing for cervical cancer screening and describes the potential benefits and disadvantages of this method.

In 2011, the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology updated their screening guidelines regarding early diagnosis of cervical cancer and its precursors. At that time, these groups recommended cytology alone and in combination with high-risk HPV testing (cotesting) as primary screening strategies, but not the use of high-risk HPV testing alone.

A prospective, US-based registration study and additional evidence now support primary HPV testing alone for screening. An application to the US Food and Drug Administration for an additional indication of primary cervical cancer screening for a currently marketed HPV test led to formation of a guidance panel. This panel included 13 experts from the Society of Gynecologic Oncology, American Society for Colposcopy and Cervical Pathology, American College of Obstetricians and Gynecologists, American Cancer Society, American Society of Cytopathology, College of American Pathologists, and American Society for Clinical Pathology.

On the basis of literature review, including data from the US Food and Drug Administration registration study, and expert opinion, the panel reached the following conclusions:

  • Compared with cytology-only screening performed at the same interval, primary HPV screening offers better reassurance of low cancer risk.

  • Primary HPV screening can be considered as an alternative to cytology alone, cotesting, and other current US cytology-based cervical cancer screening approaches.

  • For women positive for the 12 high-risk HPV genotypes other than HPV 16/18, the use of HPV 16/18 genotyping and reflex cytology reasonably balances disease detection with the number of screening tests and colposcopies needed to achieve that detection.

  • Additional data on triage options should soon be available and may result in updated triage recommendations.

  • Although primary HPV screening at age 25 to 29 years may increase cervical intraepithelial neoplasia grade 3 detection, further research is needed to determine the effect of increased number of colposcopies, integration with screening before age 25 years, and actual effect on cancer prevention.

"While there continue to be numerous practical and research questions, primary HPV testing has the potential to further reduce morbidity and mortality of cervical cancer in the US," the guidance authors conclude. "However, to achieve the maximum benefit of screening, we need to continue to identify women who are either unscreened or under-screened."

Some of the guidance authors reported various financial disclosures involving Merck, Hologic, Roche, Gen Probe, GSK, Bristol-Myers Squibb, Photocure, Hologic, Cepheid, PDS Biotechnologies, Inovio, Endocyte, Fujiboro, Eli Lilly, and/or Becton-Dickinson.

Gynecol Oncol. Published online January 7, 2015. Full text


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