On July 7, 2016, the FDA 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, a test to detect cancer of the cervix or uterus, using a specimen of cellular material from the neck of the uterus spread on a microscope slide, also known as a Pap smear, 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 now, 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.
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 test with SurePath is also able to detect high-risk HPV genotypes 16 and 18 in the same populations of women.
The Roche 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.
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.
The Roche cobas HPV Test is manufactured by Roche Molecular Systems, Inc., a part of the Roche Group, headquartered in Basel, Switzerland. SurePath Preservative Fluid is manufactured by Becton Dickinson and Company, located in Franklin Lakes, NJ.
See the FDA Announcement
See also Medical Law Perspectives, October 2012 Report: Mistakes in Diagnosing Cancer: Liability Concerns for Misdiagnosis, Failure to Diagnose, and Delayed Diagnosis
See the Medical Law Perspectives June 29, 2015, Blog: Failure to Diagnose Cancer Claims Face Hurdles, Especially in New York