FDA approves first HPV test for cervical cancer screening

SILVER SPRING, Md. — The Food and Drug Administration on Thursday approved a human papillomavirus DNA test for women 25 years of age and older that can be used alone to help health care professionals assess the need for a woman to undergo additional testing for cervical cancer. The Cobas HPV test is the first and only HPV test approved for primary screening in the United States.



The test uses a sample of cervical cells to specifically identify HPV 16 and HPV 18, while also detecting 12 other types of high-risk HPVs.  



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



Based on results of the Cobas HPV test, women who test positive for HPV 16 or HPV 18 should have a colposcopy, an exam that uses a device to illuminate and magnify the cervix so a physician can observe the cervical cells. Women who test 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.



The Cobas HPV test is manufactured by Roche Molecular Systems, which is based in Pleasanton, Calif.