ATHENA is a prospective, double-blind, multi-centered, 47,000-patient, US-registration trial designed to demonstrate the effectiveness of HPV detection as part of a cervical cancer screening program.

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 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.

As reported, preliminary analysis of data from more than 8,000 women who underwent biopsy in the ATHENA trial demonstrated that those with HPV genotype16 had the highest rate of pre-cancer, also known as cervical intraepithelial neoplasia (high-grade CIN2 and CIN3+ lesions).

In addition, HPV genotype 18 was associated with increased rates of CIN3+ disease, particularly in women 36 years and older. Data from the preliminary analysis also demonstrated that further evaluation of HPV genotypes associated with high-grade cervical disease may be warranted.

Teresa Wright, chief medical officer at Roche Molecular Diagnostics, said: “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.

“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.”