FDA Approves First HPV Test Using SurePath Preservative Fluid

The US Food and Drug Administration (FDA) just approved the first test to detect human papillomavirus (HPV) using specific samples.

The new test, manufactured by Roche Molecular Systems, Inc., will be the first to test for HPV using cervical cells from a Pap test collected in SurePath Preservative Fluid. Previously, cervical cell samples collected with SurePath were tested for HPV; however, according to an FDA press release, “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 negatives.” These false test results may result in lack of follow-up care and, later, cervical cancer. With the new Roche cobas HPV Test, laboratory personnel are provided with processing instructions that will enable labs to reduce the risk of false-negative results.

According to the FDA, HPV infections are the most common sexually transmitted infections nationwide. In addition, HPV genotypes 16 and 18 are responsible for around 70% of the cases of cervical cancer worldwide. The National Cancer Institute estimates that in the United States, 12,990 individuals will be diagnosed with HPV, and 4,120 individuals will die of the disease, in 2016.

The FDA approved the Roche test "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 test is also approved in women ages 21 years 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.” According to the release, “The test with SurePath is also able to detect high-risk HPV genotypes 16 and 18 in the same populations of women.”

Of note is that the test is “not approved as a first-line primary HPV screening test” and results of the test, when performed, should be put together with patient screening and risk factors.