Analysis of Eleven Studies Demonstrates HPV Testing is More Sensitive than Cytology in Cervical Cancer Prevention.

Authors recommend demonstration projects to show how to best implement HPV testing as primary screen, followed by cytology

GAITHERSBURG, Md., April 4 /PRNewswire-FirstCall/ -- An analysis of 11 European and North American studies involving more than 60,000 women, published in the April issue of the International Journal of Cancer, found that testing for high-risk types of the human papillomavirus (HPV) is a consistently more sensitive tool for cervical cancer screening than cytology, announced Digene Corp. . Digene markets the only FDA-approved and CE-marked test for high-risk HPV, a common virus that causes virtually all cases of cervical cancer. In the United States, The Digene(R) HPV Test is approved for use along with cytology (Pap test) to screen women age 30 and older, the group most at risk for developing cervical cancer.

The analysis found that the sensitivity of HPV testing was 96.1% overall, compared to 53% for cytology, with the latter ranging from 18.6% in one study to 76.7% in another.

"It can be seen (from this analysis) that HPV testing was consistently very sensitive in all studies for CIN2+ and CIN3+ (pre-cancer) ... while the sensitivity of cytology was substantially less and varied considerably between studies," stated the authors, led by Jack Cuzick, MD, of Cancer Research UK. "In well-screened populations like those studied, the lower sensitivity (of cytology) is associated with a high proportion of cancers occurring in apparently adequately screened women."

The analysis looked at the results of 11 published studies in six countries in North America (the United States and Canada) and Europe (the United Kingdom, France, Germany and the Netherlands), where cervical cancer screening programs have been in place for at least several years.

"HPV testing is more sensitive than cytology at all ages and in every study," concluded the authors. "These results support the use of HPV testing as the sole primary screening test, with cytology reserved for women who test positive for HPV. Large demonstration projects are needed to fully evaluate this strategy."

Worldwide, cervical cancer affects more than 400,000 women annually and, after breast cancer, is the second most common malignancy found in women. In the United States, there are an estimated 9,710 cases of cervical cancer and approximately 3,700 deaths each year.