HPV as Primary Screening for Cervical Cancer: Ready for Prime Time? ACOG Annual Clinical Meeting May 4, 2015

Educational Objectives Proposed use of new FDA approved primary HPV screening test Advantages of primary HPV screening Disadvantages of primary HPV screening

The Panel Kevin Ault, MD - University of Kansas Lori Boardman, MD - University of Central Florida Francisco Garcia, MD, MPH – Director and CMO, Pima County Health Department Moderator – David Chelmow, MD - Virginia Commonwealth University

Disclosures Ault – Site PI for clinical trials sponsored by Merck, Hologic, Roche, and Gen Probe until 2014* Boardman – none Garcia – Site PI for clinical trials by Merck, Hologic, Roche, Innovio and Photocure * Chelmow – none *All payments directly to University

Current recommendations USPSTF – Cytology alone or co-testing ACS (ACOG) – Co-testing preferred – Cytology alone acceptable Primary HPV testing discussed at 2012 ACS consensus conference, but not included in recommendation

Labeling- Primary Screening Women 25 and older Positive for HPV 16 or 18 - colposcopy HPV positive but 16/18 negative - cytology Negative tests “should be followed up in accordance with the physician’s assessment of screening and medical history, other risk factors, and professional guidelines”

Obstetrics and Gynecology February Joint publication in Gynecologic Oncology and Journal of Lower Genital Tract Disease pending

Interim Guidance “... can be considered as an alternative to current US cytology‐based cervical cancer screening methods” Manage positive tests as per labelling Rescreen after negative test “no sooner than every 3 years” Do not use prior to age 25