FDA approves new HPV test
The Roche cobas HPV Test has been approved by the FDA.
The FDA has approved the Roche cobas HPV Test, the first test for the human papillomavirus (HPV) that can use cervical cells collected in SurePath Preservative Fluid for a Pap test.
SurePath Preservative Fluid is 1 of 2 FDA-approved liquid collection fluids commonly used to collect cells for Pap tests.
“Healthcare 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 healthcare 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.”
The Roche cobas HPV Test with SurePath Preservative Fluid is approved to screen women aged 30 years and older for HPV. The test is also approved for women aged 21 years and older who have already had an abnormal Pap test result (borderline cellular cytology).
The Roche cobas HPV Test can detect high-risk HPV genotypes 16 and 18.
Some laboratories had been using cervical cell samples collected in SurePath Preservative Fluid to test for HPV even before this new approval. However, the manufacturer of SurePath warned that this may lead to false negative results, which could lead to a lack of appropriate follow-up. The Roche cobas HPV Test minimizes the risk of false negative results with specific instructions for processing.
The Roche cobas HPB Test is not approved as a first-line primary HPV screening test and should be used in conjunction with patient screening history and other risk factors.
- FDA approves first HPV test for use with SurePath Preservative Fluid [news release]. Silver Spring, MD: U.S. Food and Drug Administration; July 7, 2016. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm510251.htm. Accessed July 25, 2016.