New Clinical Guidelines for Cervical Cancer Screening and the Benefits of Implementing a Primary High-risk Human Papillomavirus Test in a High Volume Reference Laboratory

Graduation Date


Document Type

Master's Thesis

Degree Name

Master of Science

Department or Program

Clinical Laboratory Sciences

Department or Program Chair

Mary Sevigny, PhD

First Reader

Maria C. DeSousa, JD, MPA, CLS

Second Reader

James LaPan


In 2012, clinical guidelines for cervical cancer screening developed by a coalition of experts from several clinical societies such as the American Cancer Society(ACS), American Society for Colposcopy and Cervical Pathology (ASCCP), American Society for Clinical Pathology(ASCP), and the United States Preventative Service Task Force (USPSTF) agreed co-testing with cytology based Papanicolaou smear (Pap smear) and molecular based high-risk Human Papillomavirus (hrHPV) testing were the best methods for detecting early signs of cervical cancer. However, with the future of clinical tests shifting more towards the utilization of molecular diagnostics, there has been a sufficient amount of data published to support that the use of primary hrHPV testing has increased sensitivity over co-testing[1]. With new evidence in favor of molecular testing, in 2017, the USPSTF drafted new guidelines which no longer recommended the use of co-testing, and instead promotes the use of Pap smears every 3 years, or hrHPV testing every 5 years, depending on the women’s age [2]. Roche Molecular Diagnostics played a fundamental role in the changes made to the interim guidelines through developing the cobas 4800 HPV Test System, the first test to gain Food and Drug Administration (FDA) approval for use as primary HPV screening. With this platform, healthcare providers would be able to test for HPV 16 and 18 types responsible for 70% of cervical cancers, as well as 12 other hrHPV types. Implementation of the cobas 4800 in a high volume reference laboratory can improve the workflow and increase the accuracy for triage of screen positive patients. This in turn would reduce the amount of tests performed and result in potential cost savings. For patients, a higher standard of patient care would be achieved through the reduction of unnecessary follow up tests and colposcopy referrals.

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