Roche Gets FDA Approval For Cobas HPV Test To Detect Cervical Cancer

Roche Gets FDA Approval For Cobas HPV Test To Detect Cervical Cancer

April 21st, 2011 // 1:32 pm @

Swiss pharmaceutical giant Roche Holding AG (RHHBY.PK: News ) Wednesday said the U.S. Food and Drug Administration has approved its cobas HPV test to identify women at highest risk for developing cervical cancer.

Human Papillomavirus or HPV is implicated as the reason for more than 99 percent of cervical cancers worldwide. The cobas test is a qualitative in-vitro test for the detection of HPV in patient specimens.

According to Roche, the cobas test is the only FDA-approved cervical cancer screening test that allows genotypes HPV 16 and 18 concurrently with high-risk HPV testing. HPV 16 and 18 are the two highest-risk HPV genotypes responsible for more than 70 percent of cervical cancer cases. The cobas test individually identifies these genotypes while detecting 12 other high risk HPV genotypes.

The FDA’s approval of the test was based on data from the ATHENA study, which involved over 47 thousands women in the U.S. The study showed that one in 10 women of age 30 and older who tested positive for HPV 16 and/or 18 by the cobas test had cervical pre-cancer even though they showed normal results with the pap smear test.

A pap smear is a microscopic examination of cells taken from the cervix, the lower part of the uterus.

The cobas test will help physicians to make early and more accurate decisions about patient care and thereby, may prevent many women from developing this deadly disease. Further, Roche’s cobas 4800 System is designed to deliver new standards in laboratory testing and medically relevant diagnostic information. This system can run up to 282 tests in less than 12 hours.

Commenting on the FDA approval, Daniel O’Day, chief operating officer of Roche Diagnostics, stated, “We look forward to working with laboratories and physicians to introduce the cobas HPV Test into routine cervical cancer screening.”


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