The first FDA approved HPV DNA test for women who are 25 years or older has been released. The FDA approved test will enable healthcare professional decide if the women needs to undergo further testing for cervical cancer in future.
The test basically uses the cervical cells and the ‘cobas’ HPV Test which detects DNA from 14 high risk HPV’s. The test can identify in particular HPV 16 and HPV 18 and at the same time also detect 12 different types of High Risk HPV’s.
The health care worker can then recommend women who have tested positive for HPV 16 and HPV 18 in the cobas HPV Test to undergo a colposcopy. Colposcopy is essentially a device which is used by the physician to examine the histology of the cervix to determine if there is any malignancy. Women who have tested positive in the cobas test for one or more of the 12 high risk HPV types must undergo a ‘PAP’ test to ascertain if there is any need for a colposcopy. The patients screening history, risk factors and other information are used by the Healthcare professional to recommend a colposcopy.
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 said, “Today’s approval offers women and physicians a new option for cervical cancer screening. 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.”
With the FDA approval today the scope of the test has been widened to include its use as a co-test or as a primary cervical cancer screening test.