College of American Pathologists
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  With Cervista HPV 16/18 approval, now a
  genotyping algorithm


CAP Today




August 2009
Cytopathology Programs Review

Karen M. Clary, MD

HPV types 16 and 18 account for the development of 70 percent of cervical cancers worldwide. HPV genotyping to determine the specific high-risk HPV type(s) a woman is infected with is now available and FDA approved. The FDA approved for marketing in March the Cervista HPV 16/18 assay.

Studies have shown that specific types of high-risk HPV confer different levels of risk for developing CIN 2 or greater. In the Portland study, CIN 3+ was identified in 21 percent of cytology-negative HPV 16-positive and 18 percent of cytology-negative HPV 18-positive women at 10 years followup.1 This compares with a risk of CIN 3+ of only 1.5 percent in women with other high-risk HPV types. In the 2006 American Society for Colposcopy and Cervical Pathology consensus guidelines, it was stated that once the FDA approves genotyping assays for HPV types, “it would be reasonable to utilize genotyping in cytology-negative, HPV-positive women in the same manner as high-risk HPV testing is utilized in women with ASC-US.”2 In women 30 years of age and older who have combined HPV testing and cervical cytology for screening, a result of cytology-negative, HPV-positive would be triaged to HPV genotyping. Those women who test positive for HPV 16 or 18 would be referred to colposcopy. The recommendation for women with other high-risk HPV types would be retesting for both cytology and HPV in 12 months.


  1. Khan MJ, Castle PE, Lorincz AT, et al. The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst. 2005;97:1072–1079.
  2. Wright TC Jr, Massad LS, Dunton CJ, et al. 2006 American Society for Colposcopy and Cervical Pathology-sponsored Consensus Conference. 2006 consensus guidelines for the management of women with abnormal cervical cancer screening tests. Am J Obstet Gynecol. 2007;197:346–355.

Dr. Clary, a member of the CAP Cytopathology Committee, is director of cytopathology, Rochester (NY) General Hospital.

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