First HPV Test for Use With SurePath Preservative Fluid Gets FDA Approval

The approval was based on results from the ATHENA clinical study
The approval was based on results from the ATHENA clinical study

Roche announced that the Food and Drug Administration (FDA) has approved the cobas HPV Test, making it 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 cobas HPV Test and SurePath Preservative Fluid is approved for samples obtained for a Pap test to screen women aged ≥ 30 for HPV and for women aged ≥21 who have had a previous abnormal Pap test result. The test can also detect high-risk genotypes 16 and 18, however, it is not approved as a first-line primary screening test. 

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The approval was based on results from the ATHENA clinical study which included 952 women aged ≥21 with abnormal Pap test results, in which the Roche cobas HPV Test with SurePath Preservative Fluid showed similar clinical results as a previously approved cervical sample type. 

“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.”

For more information visit the FDA.gov.


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