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FDA approves Roche’s cobas HPV Test for use with SurePath Preservative Fluid

Issue: August 2016

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The FDA has approved Roche’s cobas HPV Test for use with cervical cells obtained and collected in SurePath Preservative Fluid, according to a press release.

SurePath Preservative Fluid (Becton Dickinson and Co.) is one of two FDA-approved liquid collection fluids commonly used for Pap tests, the release said. Before this approval, there were no HPV diagnostic platforms indicated for use with the collection fluid, requiring labs to either collect another sample in another fluid or risk inaccurate results.

Alberto Gutierrez

“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,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a press release.

“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.”

The cobas HPV Test (Roche Molecular Systems) with SurePath Preservative Fluid is approved for use with cervical cell samples obtained from women aged 30 years and older through a Pap test. It also is approved for use in women aged 21 years or older who already have demonstrated an abnormal Pap test result and is capable of detecting high-risk HPV genotypes 16 and 18. The test is not approved as a first-line primary HPV screening test.

This approval was based on a study of 952 women, aged 21 years and older, with prior abnormal Pap test results. According to the release, the platform was comparable with another approved cervical sample type, demonstrating 95.4% sensitivity and 93.2% specificity.

HPV infections are the most common STDs in the United States, the FDA wrote, with genotypes 16 and 18 responsible for approximately 70% of cervical cancers worldwide. Nearly 13,000 cases and more than 4,000 deaths from cervical cancers are estimated to occur in the U.S. this year, according to the National Cancer Institute.

Disclosure: Gutierrez reports no relevant financial disclosures.