April 26, 2011
The U.S. Food and Drug Administration has approved Roche Holding AG's new cobas human papillomavirus test, which can detect several high-risk strains of HPV, the firm recently announced. FDA supported the cobas HPV Test after reviewing its use in a clinical trial involving more than 47,000 women.
"The test is fully automated, has a high reliability and throughput rate," said Daniel O'Day, head of Roche's diagnostics division.
The cobas test is the first of its kind, detecting 12 high-risk HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) as a pooled result, as well as types 16 and 18 individually. HPV types 16 and 18 are responsible for about 70 percent of cervical cancer cases.
The clinical trial found that one in 10 women age 30 and older who tested positive for HPV 16 and/or 18 by cobas HPV test had cervical pre-cancer, though the Pap smear was normal.
The approval came six months earlier than expected, said Bank Vontobel analyst Andrew Weiss. O'Day expects mostly U.S. demand; however, he noted regulators in several European countries' public health departments are evaluating their cervical cancer screening programs.