Digene

Analysis of Eleven Studies Demonstrates HPV Testing Is More Sensitive Than Cytology in Cervical Cancer Prevention

    Gaithersburg, MD (ots) -

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

    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. (Nasdaq: DIGE).  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.

    "This analysis strongly reinforces conclusions from individual studies, painting a very compelling story when viewed as one body of evidence," said Attila Lorincz, PhD, Digene's Chief Scientific Officer and Senior Vice President of Research and Development. "Although the arrival of the first HPV vaccines, expected soon, will be of significant benefit, they do not offer protection against all important types of HPV and have not been demonstrated to be effective in women already infected by high-risk types of the virus. Thus, for several decades, it will continue to be critical for health care systems to use the most effective screening techniques to identify women at risk of cervical cancer. In the United States, that is a combination of cytology and HPV testing in all women age 30 and older, which offers virtually 100 percent sensitivity and negative predictive value - the ability to say with confidence that a woman is not at risk."

    About Digene

    Digene Corporation (Nasdaq: DIGE), based in Gaithersburg, MD, develops, manufactures and markets proprietary DNA and RNA testing systems for the screening, monitoring and diagnosis of human diseases -- with a focus on women's cancers and infectious diseases. The company's hc2 High-Risk HPV DNA Test(R) is the only test for human papillomavirus approved by the U.S. Food and Drug Administration (FDA), for both follow-up evaluation in women with inconclusive Pap results and for primary adjunctive screening with the Pap test in women age 30 and older. For primary adjunctive screening, it is marketed as both The Digene HPV Test and the DNAwithPap(R) Test. These brand names do not refer to the Digene product that tests for several types of the virus commonly referred to as "low-risk HPV," which are not associated with cervical cancer. For more information, visit www.thehpvtest.com.  Digene's HPV test is CE-marked in Europe and is marketed in more than 40 countries worldwide.  In addition, Digene's product portfolio includes DNA tests for the detection of other sexually transmitted infections, including chlamydia and gonorrhea, as well as tests for blood viruses. For more information, visit the company's Web site, www.digene.com.

ots Originaltext: Digene
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