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FDA Approves First HPV Test for Use With SurePath Preservative Fluid


On July 7, 2016, the U.S. Food and Drug Administration (FDA) approved the Roche cobas HPV Test as the first test for human papillomavirus (HPV) that can be used with cervical cells obtained for a Papanicolau (Pap) test and collected in SurePath Preservative Fluid.

The FDA approves 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.

False-Negative Results Minimized


Now health-care providers have access to an FDA-approved test [for HPV in cervical cells] and the information they need to use it properly to ensure the most accurate results for their patients.
— Alberto Gutierrez, PhD

“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, PhD, 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 this 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 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.

The 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 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.

The 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.

Clinical Study

The FDA based its approval of the 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 cobas HPV Test with SurePath Preservative Fluid demonstrated similar clinical performance when compared with a previously approved cervical sample type.

Of the samples that tested positive for HPV using the 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 cobas HPV Test with SurePath, 93.2% obtained the same result as the reference sample. ■



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