FDA approves new HPV Test could replace Pap test

womenAs we reported last month, an advisory panel to the FDA recommended that the agency approve a new test for human papillomavirus (HPV) for screening women for cervical cancer. The new test could potentially replace the current Pap test that has been in use for decades.

Now the FDA has taken the advice of the panel and approved the cobas HPV test (trademark name of the test by Roche Pharmaceutical) for primary cervical cancer screening. Unlike the Pap test, which relies of inspection of cells taken from a woman s cervix for evidence of abnormalities, the new test involves examining the viral DNA derived from these samples. If any DNA from a strain of HPV that is known to be associated with cancer is found, then further tests or intervention will be instigated.

Convincing evidence of the improved sensitivity of the cobas test compared to the Pap test was derived from a prospective study of over 47,000 women over the age of 25. In addition, the newer test also was more accurate than the Pap test.

ACSH s Dr. Gilbert Ross commented This is how medical progress should work. The Pap test has been used to screen women for decades, and has been a reliable indicator of cervical cancer risk. Now a new test seems to be even more precise, and thus will likely replace it. Hopefully, more young women will have been vaccinated against HPV, and thus the rates of cervical cancer will fall no matter which test is used.