Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that data from the ATHENA (Addressing THE Need for Advanced HPV Diagnostics) U.S. registration trial of over 47,000 women demonstrate that two human papillomavirus genotypes, HPV 16 and HPV 18, can identify those women with cervical pre-cancer 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 pre-cancer, 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 data were presented today by Thomas C. Wright Jr., M.D. of Columbia University at the 26th International Papillomavirus Conference in Montreal, Canada.
"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."