OCT 07, 2020 9:00 AM PDT

Clinical Utility of Extended Genotyping

Sponsored by: BD
C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • Board certified in Anatomic Pathology; Professor Emeritus of Pathology and Cell Biology, Columbia University; Consulting Pathologist, Enzo Clinical Laboratories
    Biography
      Dr. Wright received his Medical Degree from Harvard Medical School; his pathology residency training at Brigham and Women's Hospital, Boston, Massachusetts, and his fellowship in OB/Gyn Pathology at Columbia University. Dr. Wright served as the Director of the Division of Gynecologic, Perinatal, and Cytologic Pathology at Columbia University Medical Center and also headed the colposcopy services at New York Presbyterian Hospital for over 15 years. He is a Past President of the American Society of Colposcopy and Cervical Pathology and was the lead author of the 2001 and 2007 ASCCP Consensus Guidelines for the Management of Cytologic Abnormalities. He is now a Professor Emeritus of Pathology and Cell Biology at Columbia University and is involved in a variety of clinical trials focusing primarily on the development of diagnostic and risk-assessment tests for cervical disease both in the U.S. and low resource settings. He was one of the lead investigators for the recently completed Onclarity HPV trial that was used to obtain FDA clearance for the BD Onclarity HPV assay. He has published over 250 articles and chapters on HPV and cervical disease. In addition to clinical research, Dr. Wright is in active clinical practice as a gynecological pathologist at Enzo Clinical Laboratories.

    Abstract
    Date:  October 7, 2020
    Time: 9:00am (PDT),  12:00pm (EDT)
     
    Recently the FDA approved the BD Onclarity™ HPV assay as a test to identify HPV high-risk genotypes in addition to HPV 16 and 18 (i.e., extended genotyping). The Onclarity assay is designed to identify the 14 high-risk HPV genotypes either individually (HPV 16, 18, 31, 45, 51, 52) or as a pooled mixture of two to three genotypes (HPV 33/58, 35/39/68, 56/59/66). Because different HPV genotypes are associated with different risks of CIN 3, the use of extended genotyping offers a useful tool when following the “risk-based” management strategy recently adopted by the American Society of Colposcopy and Cervical Pathology (ASCCP). For example, when screening using cotesting, women with a NILM cytology result who are positive for HPV 31 have more than twice the 3 year cumulative incidence rate (CIR) for CIN 3 (9%) as HPV 18 positive women (4.4%) and over three times the 3 year CIR for CIN 3 as women with HPV 45, 52, or 33/58 (2.9-2.3%). This suggests that women with NILM who are positive for HPV 16, 31, or 18 should be referred for immediate colposcopy whereas women positive for HPV 45, 52, or 33/58 should undergo repeat cotesting at 12 months. Moreover, women with NILM who are positive for only HPV 56/59/66 have a low enough 3 year CIR (0.3%) that they could simply return for repeat cotesting in 3 years. Extended genotyping can also assist in the management of women with ASC or LSIL cytology. Women with ASC or LSIL cytology who are positive for either HPV 33/58 or HPV 45 have a low enough 3 year CIR (3.7% and 2.1%, respectively) that they could return in 12 months for repeat cotesting rather than undergo immediate colposcopy. As with women with NILM cytology, the 3 year CIR for women with ASC or LSIL cytology who are positive only for HPV 56/59/66 is low enough (0.0%) that they could safely return for repeat cotesting in 3 years.
     
    Learning Objectives
    • Describe the unmet needs associated with current “risk-based” management guidelines for women with abnormal cervical cancer screening tests.
    • Formulate strategies that maximize the risk stratification obtained using extended genotyping within clinical practice.
     
     
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