Description of Procedure

The American Cancer Society estimates that in the year 2005 there will be 10,370 newly diagnosed cases of cervical cancer (excluding in situ carcinomas) and 3710 women will die of the disease. The incidence has decreased markedly in the last 50 years in large part due to the availability of cytologic testing for early diagnosis, treatment, and ultimately prevention of cervical cancer.

HPV (human papillomavirus) testing is being considered as an alternative or an adjunctive test to cytologic testing (i.e., Pap smear). Although screening with Pap smears has been shown to have significantly reduced the incidence of cervical cancer, the false-negative rate of a single Pap test is reported to be 20%; however, the false negative rate of 3 or more consecutive negative annual screens may be as low as 1%. Such testing requires at least 3 office visits over 3 years to be confident concerning the absence of abnormal cytology and thus is inefficient. It has been recently discovered that cervical carcinomas and their precursors are directly related to the presence of HPV. HPV, especially a high-risk HPV type, is considered necessary, but not sufficient, for the development of cervical cancer or its precursors. Thus, due to the present inaccuracies of the Pap smear, specifically the high false negative rate, HPV DNA testing has been studied as an alternative to or an adjunct to cytology in terms of primary screening and in terms of triage of patients with borderline or equivocal cytology to further testing.

Committee Conclusions

With regard to human papillomavirus (HPV) DNA testing for the screening and monitoring of cervical cancer, the ICSI Technology Assessment Committee finds the following:

1. In women 30 years of age or older who have an ASCUS (atypical squamous cells of undetermined significance) cervical cytology result, the HPV DNA test, when performed as a reflex test (where performance of the test is contingent on an ASCUS cytology) is safe and efficacious for use in selecting women for referral to colposcopy and biopsy (positive HPV DNA test) or for monitoring at 6 months and 12 months (negative HPV DNA test). (Conclusion Grade II)
   
2. In women 30 years of age or older, automatic HPV DNA testing is safe and efficacious for use as an adjunct to cervical cytology to allow less frequent screening for cervical cancer. If both the HPV DNA and the cervical cytology results are negative, the woman is considered at low risk for cervical cancer. Such women may be screened at longer intervals, such as every three years. This conclusion is not applicable for women with a recent change in sexual partner. (Conclusion Grade II)
   
3. The evidence does not support the use of HPV DNA testing alone as a primary screening tool. Therefore, HPV DNA testing should not be used as a standalone test in this capacity.
   
4. There is not enough evidence to permit conclusions regarding the use of HPV DNA testing for the monitoring of treatment response or in selecting patients at high risk of relapse following treatment of CIN or cervical cancer.
   
5. The test procedure for HPV DNA is safe. The risk lies in what is done with the results. Failure to diagnose high-grade squamous intraepithelial lesions (HSIL) or invasive cervical cancer (false negative) or referral to colposcopy or biopsy when not needed (false positive) may result in morbidity or mortality.