The U.S. Food and Drug Administration approved the Roche cobas HPV Test as the first test for Human Papilloma Virus (HPV) that can be used with cervical cells obtained for a 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.
“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.”
HPV infections are the most common sexually-transmitted infections in the United States, and HPV genotypes 16 and 18 cause approximately 70 percent of cervical cancers worldwide. According to the National Cancer Institute, there will be an estimated 12,990 new cases and 4,120 deaths from cervical cancer in the United States during 2016.
The Roche 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 Roche 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 FDA based its approval of the Roche 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 Roche cobas HPV Test with SurePath Preservative Fluid demonstrated similar clinical performance when compared to a previously approved cervical sample type. Of the samples that tested positive for HPV using the Roche cobas HPV Test with SurePath, 95.4 percent obtained the same result as the reference sample. Of the samples that tested negative for HPV using the Roche cobas HPV Test with SurePath, 93.2 percent obtained the same result as the reference sample.
