April 24, 2014
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FDA approves HPV test for primary cervical cancer

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The FDA today approved the cobas HPV Test for women aged at least 25 years to be used alone to aid a health care professional assess the need to undergo additional diagnostic testing for cervical cancer.

Using a sample of cervical cells, the cobas HPV Test (Roche) detects DNA from 14 high-risk HPV types. The test specifically identifies HPV types 16 and 18 while simultaneously detecting 12 other types of high-risk HPVs.

Based on results of the cobas HPV Test, women who test positive for HPV types 16 or 18 should have a colposcopy.

Alberto Gutierrez, PhD 

Alberto Gutierrez

 “Today’s approval offers women and physicians a new option for cervical cancer screening,” said 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.”

Data supporting the use of the cobas HPV Test as a primary screening test for cervical cancer included a study of more than 40,000 women aged at least 25 years undergoing routine cervical exams.

Women who had a positive Pap test or whose cervical cells screened positive for HPV, as well as a subset of women whose Pap and HPV tests were both negative, underwent a colposcopy and cervical tissue biopsy. All biopsy results were compared with the Pap and cobas HPV Test results. Data from this study, which included 3 years of follow-up on women who went to colposcopy, showed that the cobas HPV Test is safe and effective for the new indication for use.

The cobas test received FDA approval in April 2011 for follow-up screening of patients aged at least 21 years who had abnormal cervical cytology results and for use adjunctively with normal cervical cytology in women aged at least 30 years to assess the presence or absence of high-risk HPV genotypes.

This approval expands the use of the test to include use as 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.

Women testing positive for one or more of the 12 other high-risk HPV types should receive a Pap test to determine the need for a colposcopy. Health care 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.