FDA Approves First HPV Test for Use With SurePath Preservative Fluid

Alberto Gutierrez, PhD

The FDA has approved the cobas HPV Test for use with SurePath Preservative Fluid for the detection of human papilloma virus (HPV) in cervical cells. SurePath is one of the two approved liquid collection fluids commonly used 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 cobas HPV Test with SurePath 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 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, healthcare professionals should use the cobas HPV test results together combined other information, such as the patient screening history and risk factors.

The approval was based on a clinical study of 952 women 21 years and older with abnormal Pap test results. Of the samples that tested positive for HPV using the cobas HPV Test with SurePath, 95.4% obtained the same result when compared with a previously approved cervical sample types.

Of the samples that tested negative for HPV using the cobas HPV Test with SurePath, 93.2% obtained the same result when compared with the reference sample. The test, which is a qualitative multiplex assay manufactured by Roche Diagnostics, detects genotype-specific information from 14 high-risk HPV types, including HPV 16 and 18.

Prior to the FDA approval, some laboratories already began using cervical cell samples collected in SurePath to run HPV tests, instead of collecting an additional sample in a separate collection fluid that had been approved for use with those tests. The FDA had not approved any HPV tests to be used with SurePath previously.

In 2012, Becton Dickinson and Company, the manufacturer of SurePath, warned laboratories that using cervical cell samples in SurePath with a specific HPV test might 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 provides specific instructions for laboratories to process cervical samples collected in SurePath, minimizing the risk of false negative results, reports the FDA.

The FDA approved the cobas HPV Test as a first-line screening tool for cervical cancer in women aged 25 years and older in 2014, based on the results of the large ATHENA study, which included specimens from 41,955 women.

The study demonstrated that the test was 15.63% more sensitive at detecting cervical intraepithelial neoplasia grade 3 when compared with liquid-based cytology.

The FDA initially approved the cobas HPV Test in 2011 as a secondary or adjunctive cervical screening tool.

HPV infections are the most common sexually transmitted infections in the United States, and HPV genotypes 16 and 18 cause approximately 70% 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.