Accepting the recommendation made by an advisory committee last month, the U.S. Food and Drug Administration (FDA) approved the Roche cobas HPV (human papillomavirus) Test yesterday as a first-line primary screening tool in women 25 years and older to assess their risk of cervical cancer based on the presence of clinically relevant high-risk HPV DNA. Using a sample of cervical cells, the cobas HPV Test detects DNA from 14 high-risk HPV types. The test specifically identifies HPV 16 and HPV 18, while concurrently detecting 12 other types of high-risk HPVs.
Based on results of the cobas HPV Test, women who test positive for HPV 16 or HPV 18 should have a colposcopy, Women testing positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy. Healthcare professionals should use the cobas HPV Test results together with other information, such as the patient screening history and risk factors, and current professional guidelines.
“Today’s approval offers women and physicians a new option for cervical cancer screening,” says Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer.”
The agency’s action includes use of the assay as either a co-test or as a primary cervical cancer screening test, however; it does not change current medical practice guidelines for cervical cancer screening. These guidelines are developed, reviewed, and modified by groups other than the FDA. Read more about the cobas HPV test.Read more