FDA approves HPV test for first-line screening

April 29, 2014

Contemporary OB/GYN editorial board member Ilana Cass, MD, offers perspective on the recent FDA approval of the first-ever alternative to Pap smear cytology cervical screening.

 

Contemporary OB/GYN editorial board member Ilana Cass, MD, offers perspective on the recent FDA approval of the first-ever alternative to Pap smear cytology cervical screening.

"The Food and Drug Administration has approved the cobas HPV test as first-line testing for cervical cancer screening in women ages 25 and older. The significance of this approval is that HPV testing would be the first-ever alternative to Pap smear cytology cervical screening.  The endorsement was based upon results from the ATHENA study, which showed that HPV testing was more sensitive in identifying cervical intraepithelial neoplasia-3 (CIN-3) when compared to liquid-based Pap smear cytology. The ATHENA trial is the largest HPV screening trial in the United States with almost 41, 000 women aged 25 or older, although final results of the ATHENA trial have not yet been published. The FDA approval of primary HPV testing means that primary HPV testing is considered a safe and effective option to screen women for cervical cancer, but the FDA approval does not issue guidelines about the use of a test or change current screening recommendations. Organizations such as SGO, ACOG and the ASCCP are currently working to develop interim guidelines to determine how primary HPV testing will be incorporated into cervical cancer screening."