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# FDA OKs Roche HPV Test with SurePath Fluid
- URL: https://www.fdaweb.com/fda-oks-roche-hpv-test-with-surepath-fluid/
- Published: 2016-07-11T12:00:00.000Z
- Updated: 2026-09-14T21:13:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136117

FDA has approved the Roche cobas HPV test as the first test for human papilloma virus that can be used with cervical cells obtained for a Pap test and collected in SurePath preservative fluid. An agency [statement](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510251.htm?ref=fdaweb.com) says that the Roche test is the first to be approved for use with SurePath fluid, one of two approved liquid collection fluids commonly used for Pap tests.

Prior to the approval, the statement says, some laboratories used cervical cell samples collected in SurePath fluid to run HPV tests, rather than collect an additional sample in a separate collection fluid that had been approved for use with those tests. In 2012, the SurePath manufacturer warned laboratories that using cervical cell samples in its fluid with a specific HPV test may lead to false negative results. The Roche test now provides specific instructions for laboratories to process cervical samples collected in SurePath preservative fluid to minimize the risk of false negative results, FDA says.

The Roche cobas HPV test with Sure Path preservative fluid is approved for use with cervical cell samples obtained for a Pap test to screen women age 30 and older for HPV to determine whether additional follow-up and diagnostic procedures are needed. FDA also approved the protocol for women age 21 and older who have already had an abnormal Pap test result to determine whether additional follow-up and diagnostic procedures are needed. The new test is also able to detect high-risk HPV genotypes 16 and 18 in the same population of women.

FDA says that the new test is not approved as a first-line primary HPV screening test. Healthcare professionals are advised to use the test results together with other information such as the patient screening history and risk factors.

Approval of the test was based on a study of 952 eligible women age 21 and older with abnormal Pap test results. The test demonstrated similar clinical performance when compared to a previously approved cervical sample type.