Roche gets FDA OK for HPV test

The FDA has given its blessing to Roche's cobas HPV test, which is designed to identify women at highest risk for developing cervical cancer.

The test individually identifies HPV genotypes 16 and 18, which are responsible for more than 70 percent of cervical cancer cases. It also simultaneously detects 12 other high-risk HPV genotoypes. The approval was based on data from the ATHENA study involving more than 47,000 women in the U.S. Results demonstrated that one in 10 women over the age of 30 who tested positive for HPV 16 and/or 18 by the cobas HPV Test actually had cervical precancer even though they showed normal results with the Pap test, according to a company statement.

Each year, there are more than 55 million Pap smear tests performed in the U.S. Current guidelines for screening allow for either cytology or cytology plus HPV testing to determine the risk of cervical cancer. However, HPV testing--and 16 and 18 genotyping in particular--identifies more women at risk earlier than Pap cytology testing alone.

"This is a great achievement for us," said Daniel O'Day, who heads Roche's diagnostics division, as quoted by Dow Jones. "The test is fully automated, has a high reliability and throughput rate," he added. O'Day expects the test to boost the division's sales, which had revenues of 10.4 billion Swiss francs (roughly $11.7 billion) in 2010.

Competing tests are marketed by Qiagen and Hologic, which have a leading share in the estimated $300 million HPV test market in the U.S. O'Day didn't specify the sales potential of the test, but Bank Vontobel analyst Andrew Weiss, who said the approval came some six months earlier than expected, estimated the test could help generate annual revenues of around $400 million, according to Dow Jones.

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