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HPV Test Approved for Initial Screening of Cervical Cancer

FDA news release; 2016 Jul 7

The FDA has approved the Roche cobas HPV Test (Roche Molecular Systems, Inc.), the first test for HPV that can be used with cervical cells obtained for a Pap test and collected in SurePath Preservative Fluid.

Indication: The Roche cobas HPV Test with SurePath Preservative Fluid is approved for use with cervical cell samples obtained for a Pap test to screen women age 30 and older for HPV in order to determine whether additional follow-up and diagnostic procedures are needed. The FDA also approved the Roche cobas HPV Test with SurePath in women age 21 and older who have already had an abnormal Pap test result (borderline cellular cytology) in order to determine whether additional follow-up and diagnostic procedures are needed. The test with SurePath is also able to detect high-risk HPV genotypes 16 and 18 in the same populations of women.

Safety and efficacy: The FDA based its approval of the Roche cobas HPV Test with SurePath Preservative Fluid on a clinical study of 952 eligible women 21 years and older with abnormal Pap test results. The Roche cobas HPV Test with SurePath Preservative Fluid demonstrated similar clinical performance when compared to a previously approved cervical sample type. Of the samples that tested positive for HPV using the Roche cobas HPV Test with SurePath, 95.4% obtained the same result as the reference sample. Of the samples that tested negative for HPV using the Roche cobas HPV Test with SurePath, 93.2% obtained the same result as the reference sample.

The Roche cobas HPV Test with SurePath is not approved as a first-line primary HPV screening test. In addition, health care professionals should use the cobas HPV Test results together with other information, such as the patient screening history and risk factors.

Citation: US Food and Drug Administration. FDA approves first HPV test for use with SurePath Preservative Fluid. FDA Web site. July 7, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510251.htm. Accessed July 11, 2016.