FDA approves first HPV test for use with SurePath Preservative Fluid

The U.S. Food and Drug Administration has approved the first test for Human Papilloma Virus (HPV). The method uses cervical cells collected with SurePath Preservative Fluid.

The Roche cobas HPV Test is able to use SurePath Preservative Fluid, one of two approved liquid collection fluids commonly used for Pap tests, to the same accuracy as a previously collected cervical sample.

With rates of HPV rising, new cases are estimated top 12,990 with 4,120 deaths by 2016, the ability to test and identify these cases early can be significant.

The Roche test has been approved for both the use of samples taken for a Pap smear in women aged 30 over (and women 21 and over who have had an abnormal Pap smear) to determine the need for follow-up care.

A clinical study, from where the FDA approval is based, analyzed 952 women aged 21 and older with abnormal Pap test results and found that using the Roche cobas HPV Test with SurePath was 95.4 percent as accurate for positive HPV patients and 93.2 percent as accurate for those who tested negative when compared to a reference sample.

“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, PhD, 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.”