Roche Announces Expanded CE Mark Indication for cobas® 4800 HPV Test Supporting Its Use as a Primary Screen for Cervical Cancer

Roche Announces Expanded CE Mark Indication for cobas® 4800 HPV Test Supporting Its Use as a Primary Screen for Cervical Cancer PR Newswire PLEASANTON, California, Nov. 27, 2012 -- HPV DNA detection finds disease missed by Pap cytology PLEASANTON, California, Nov. 27, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announces an expanded CE mark indication for the cobas® 4800 HPV Test. The newly expanded indication for the cobas® 4800 HPV Test as a primary screen means Pap cytology is no longer required as a co- or pre-test in countries that accept a CE mark. Persistent infection with Human Papillomavirus is the principal cause of cervical cancer in women. The expanded indication is supported by data to be presented at the International Papillomavirus Conference, November 30-December 6, 2012 in San Juan, Puerto Rico. "HPV testing provides a more sensitive level of screening than the Pap test. Whereas a Pap smear looks for abnormal cells, an HPV test looks for the presence of HPV DNA itself," says Eduardo Franco, director, Division of Cancer Epidemiology, McGill University, Montreal, Canada. "The prevalence of HPV means that many women may test positive, so it is important to also identify those most at risk to progress to cervical cancer. Genotyping for HPV types 16 and 18 provides sufficient additional specificity to identify the women most at risk, and spares the rest from potentially unnecessary intervention.