7 July 2016 - The U.S. FDA today 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.

The FDA approves human papilloma virus (HPV) tests to be used with specific collection fluid, which store and preserve cervical cell samples for testing in the laboratory. Until today, the FDA had not approved any HPV tests to be used with SurePath Preservative Fluid, one of two approved liquid collection fluids commonly used for Pap tests.

“Health care providers have been using samples stored in the SurePath Preservative Fluid with HPV tests for some time now, but there have been concerns about false negative results,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Now health care providers have access to an FDA-approved test and the information they need to use it properly to ensure the most accurate results for their patients.”

Prior to today’s approval, some laboratories used cervical cell samples collected in SurePath Preservative Fluid to run HPV tests, in lieu of collecting an additional sample in a separate collection fluid that had been approved for use with those tests. In 2012, the manufacturer of SurePath warned laboratories that using cervical cell samples in SurePath Preservative Fluid with a specific HPV test may lead to false negative results. Patients who receive false negative HPV test results may not receive appropriate follow-up care, which could lead to cervical cancer progression. The Roche cobas HPV Test now provides specific instructions for laboratories to process cervical samples collected in SurePath Preservative Fluid to minimize the risk of false negative results.

View FDA press release