While the FDA approves HPV tests to be used in conjunction with specific collection fluids, this is the first approved HPV test to use SurePath Preservative Fluid — one of two approved collection fluids commonly used for Pap tests.
The FDA approved the test to screen women age 30 or older for HPV to determine whether additional follow-up and diagnostic procedures are necessary. The test is also approved for use in women age 21 or older who have already had an abnormal Pap test result.
The Roche cobas HPV test, developed by Roche Molecular Group in Switzerland, is not intended to be a first-line screening test for HPV.
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