Print this page    •   Back to Web version of article

Medical News
U.S. Backs Roche Cervical Cancer Test

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.

Advertisement

"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.

Back to other news for April 2011

Excerpted from:
Wall Street Journal
04.20.2011; Goran Mijuk




This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. You can find this article online by typing this address into your Web browser:
http://www.thebody.com/content/art61692.html

General Disclaimer: TheBody.com is designed for educational purposes only and is not engaged in rendering medical advice or professional services. The information provided through TheBody.com should not be used for diagnosing or treating a health problem or a disease. It is not a substitute for professional care. If you have or suspect you may have a health problem, consult your health care provider.