The U.S. ''Addressing the Need for Advanced HPV Diagnostics'' (ATHENA) registration trial involved more than 47,000 women. The trial was designed to answer current medical and scientific questions about the importance of testing for high-risk HPV genotypes in cervical cancer screening and to provide clinical information about the specific HPV genotypes that put women at highest risk for developing cervical cancer.

The Roche (Basel, Switzerland) cobas 4800 HPV test simultaneously detects 12 high-risk HPV types (HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) as a pooled result, as well as HPV genotypes 16 and 18 individually.

Roche announced that data from the ATHENA trial verified that two human papillomavirus genotypes, HPV 16 and HPV 18, could identify those women with cervical precancer missed by cytologic examination with a Papanicolau (Pap) test.

In the trial, 1 in 10 women age 30-years and older, who tested positive for HPV genotypes 16 and/or 18 by the cobas 4800 HPV test had cervical precancer, although their Pap test was normal. The data demonstrate the importance of HPV genotyping to increase the accuracy of assessing cervical cancer risk, especially by screening for the two highest risk HPV genotypes (16 and 18), and underscore the limitations of relying upon cytology (Pap) testing alone in identifying women with cervical pre-cancer.

The results of the trial were presented by Thomas C. Wright Jr., M.D., of Columbia University (New York, NY, USA) at the 26th International Papillomavirus Conference in Montréal, Canada, which was held from July 3-8, 2010.

“The ATHENA data show that women who are positive for HPV 16 and/or 18 should be directly referred for closer examination of the cervix by colposcopy,” said Dr. Wright. “Screening for high-risk HPV genotypes provides important additive information to Pap testing, and screening for the two highest risk types, HPV 16 and 18, should be included to provide predictive information about a woman’s risk for having cervical pre-cancer or cancer.”

Persistent infection with human papillomavirus is the principal cause of cervical cancer in women, with HPV implicated in more than 99% of cervical cancers worldwide. Of the more than 118 different types of HPV, 13-16 types are currently considered high-risk for the development of cervical cancer and its precursor lesions. Nucleic acid (DNA) testing is a sensitive and noninvasive method for determining the presence of a cervical HPV infection.

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