FDA approves Roche HPV DNA test for primary cervical cancer screening


The FDA granted its first approval to an HPV DNA test for women 25 and older that can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can provide information about the patient’s risk for developing cervical cancer in the future. The FDA first approved the test, called the cobas HPV Test, in 2011 for use in conjunction with or as a follow-up to a Pap test , which examines cervical cells for changes that might become cervical cancer. Today’s approval expands the use of the test to include use as either a co-test or as a primary cervical cancer screening test, however; it does not change current medical practice guidelines for cervical cancer screening. The cobas HPV Test is manufactured by Roche Molecular Systems.

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