Roche's HPV test gets FDA approval for primary cervical cancer screen

Roche's Cobas HPV test--Courtesy of Roche

Roche ($RHHBY) has won FDA approval for its HPV test used for primary screening of cervical cancer. The regulatory nod is expected to increase the company's profile in the U.S. and grow its 20% share of the global diagnostics markets.

The Cobas test is the first FDA-approved frontline HPV DNA test for women 25 and older that can be used by itself to assess whether a patient needs additional diagnostic testing for the cancer. It also provides information about the patient's risk for developing cervical cancer in the future. Last month, the test received a glowing review from the agency's Microbiology Devices Panel of the Medical Devices Advisory Committee.

"We are very pleased that the FDA has approved this test for first-line use in cervical cancer screening," Roland Diggelmann, COO Division Roche Diagnostics, said in a release. "We are committed to working with the medical community and professional organizations to put the necessary clinical practice guidelines in place to encourage providers to incorporate this new screening strategy alternative in their patient protocols."

The Swiss company began the long campaign for its HPV test in 2011 when it secured FDA approval for use of Cobas to screen patients 21 and older who presented with abnormal cervical cytology results, and to identify high-risk HPV genotypes in women 30 and older. It also was green-lighted for use in tandem with Pap cytology as part of the cervical cancer screening process.

Last June, Roche filed for a submission for the PMA supplement for its diagnostic test. That filing included three years worth of data from Roche's ATHENA study, which screened more than 47,000 women for cervical disease. The study's results concluded that about one in 7 women with normal Pap cytology who were HPV 16 positive had high-grade cervical disease that was missed by cytology.

- read the FDA announcement
- see the Roche release

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