Preliminary Data from Roche ATHENA Cervical Cancer Trial

Support Value of Human Papillomavirus Genotyping

PR News

MONTE CARLO, Monaco, Feb. 18 /PRNewswire-FirstCall/

Roche Molecular Systems, Inc. (SIX: RO, ROG; OTCQX: RHHBY) announced today that preliminary data from its ATHENA (Addressing THE Need for Advanced HPV Diagnostics) trial support the importance of screening for human papillomavirus (HPV) genotypes that put women at highest risk for developing cervical cancer. ATHENA is a prospective, double-blind, multi-centered, 47,000-patient, U.S.-registration trial designed to demonstrate the effectiveness of HPV detection as part of a cervical cancer screening program. Thomas C. Wright Jr., M.D., of Columbia University presented the preliminary data on February 18 during the Genotyping session (Scientific Session 2) at the EUROGIN 2010 congress in Monaco.

“The findings to date from the ATHENA trial support the growing understanding that certain HPV genotypes are highly associated with the development of high-grade cervical intraepithelial neoplasia (CIN grade 2 or higher), a direct precursor to cervical cancer,” said Dr. Wright.

Persistent infection with HPV is the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide. Cervical cancer is a global public health problem, accounting for 10 percent of all cancers in women. While the Papanicolaou cytology smear (Pap smear) has reduced deaths from cervical cancer by 70 percent in developed countries, the Pap smear has demonstrated limited ability to detect cervical cancer and its pre-cancer lesions based on a single test result. As a result, physicians are increasingly using HPV DNA testing together with Pap smears to more precisely determine a woman’s risk for developing cervical cancer.

“While significant progress has been made in screening for cervical cancer over the past 50 years, it is clear that testing for HPV DNA as part of a cancer screening program allows the identification of cancer and its precursors earlier than when Pap smear alone is used,” said Teresa Wright, M.D., chief medical officer, Roche Molecular Diagnostics. “In HPV positive women 30 years and older with normal pap smears, current screening guidelines recommend testing for specific HPV genotypes to identify those with the highest risk for cancer and its precursors. The demonstrated cervical disease in women with HPV genotype 16 enrolled in ATHENA supports these recommendations.”

About the Roche ATHENA Trial

The Roche ATHENA trial is designed to answer current medical and scientific questions about the importance of testing for human papillomavirus (HPV) genotypes in cervical cancer screening and to provide additional information about the specific HPV genotypes that put a woman at highest risk for developing cervical cancer. The Roche ATHENA HPV trial enrolled 47,000 women and screened participants for cervical cancer using the Pap test and HPV DNA tests for 14 genotypes that are known to put women at high risk. All women with a positive HPV test and a positive Pap test in the trial were referred for further blinded investigation of whether they had cervical cancer or pre-cancerous disease.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.