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Apr 20, 2011

FDA Clears Roche’s Cobas Assay for 14 HPV Genotypes

  • FDA has cleared Roche’s cobas HPV test for identifying women at high risk of developing cervical cancer. The firm claims clearance means the previously CE-marked assay is now the only FDA-approved test that allows HPV 16 and HPV 18 genotyping at the same time as testing for 12 other high-risk HPV genotypes.

    Approval of cobas HPV was based on data from the Athena study in over 47,000 U.S. women. The trial showed that 1 in 10 women aged 30 years or more who tested positive for HPV 16 and/or 18 actually had cervical precancer, even though their Pap test results were normal.

    HPV infection is implicated in over 99% of cervical cancers worldwide, Roche notes. NCI figures suggest there are 12,200 new cases of the disease in the U.S. every year, and 4,210 cervical cancer-related deaths. WHO estimates suggest there are over 470,000 new cases of cervical cancer worldwide annually.

Readers' Comments

Posted 04/20/2011 by hello00

Having HPV or other STDs is not the end of world. SingleHerpes,com says Over 70 million people are living with STDs in the U.S., as well as an estimated 400 million people worldwide. they have 600,000+ members, some famous ppl also find support there. wish you luck and find someone understand you.

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