Evaluation of TypeSeq, a Novel High-Throughput, Low-Cost, Next-Generation Sequencing-Based Assay for Detection of 51 Human Papillomavirus Genotypes
Year: 2019
Type: article
Abstract: BACKGROUND: Human papillomaviruses (HPV) cause over 500 000 cervical cancers each year, most of which occur in low-resource settings. Human papillomavirus genotyping is important to study natural history and vaccine efficacy. We evaluated TypeSeq, a novel, next-generation, sequencing-based assay that detects 51 HPV genotypes, in 2 large international epidemiologic studies. METHODS: TypeSeq was evaluated in 2804 cervical specimens from the Study to Understand Cervical Cancer Endpoints and Early Determinants (SUCCEED) and in 2357 specimens from the Costa Rica Vaccine Trial (CVT). Positive agreement and risks of precancer for individual genotypes were calculated for TypeSeq in comparison to Linear Array (SUCCEED). In CVT, positive agreement and vaccine efficacy were calculated for TypeSeq and SPF10-LiPA. RESULTS: We observed high overall and positive agreement for most genotypes between TypeSeq and Linear Array in SUCCEED and SPF10-LiPA in CVT. There was no significant difference in risk of precancer between TypeSeq and Linear Array in SUCCEED or in estimates of vaccine efficacy between TypeSeq and SPF10-LiPA in CVT. CONCLUSIONS: The agreement of TypeSeq with Linear Array and SPF10-LiPA, 2 well established standards for HPV genotyping, demonstrates its high accuracy. TypeSeq provides high-throughput, affordable HPV genotyping for world-wide studies of cervical precancer risk and of HPV vaccine efficacy.
Authors: Sarah Wagner, David Roberson, Joseph Boland, Aimée R Kreimer, Meredith Yeager, Michael Cullen, Lisa Mirabello, S Terence Dunn, Joan Walker, Rosemary Zuna, Carolina Porras, Bernal Cortes, Joshua Sampson, Rolando Herrero, Ana Cecilia Rodriguez, Wim Quint, Leen-Jan Van Doorn, The CVT Group, San José, Paula González, Rolando Herrero, Silvia E Jiménez, Carolina Porras, Ana Cecilia Rodríguez, Allan Hildesheim, Aimée R Kreimer, Douglas R Lowy, Mark Schiffman, John T Schiller, Mark Sherman, Sholom Wacholder, Ligia A Pinto, Troy J Kemp, Mary K Sidawy, Wim Quint, Leen-Jan van Doorn, Linda Struijk, Joel M Palefsky, Teresa M Darragh, Mark H Stoler, Allan Hildesheim, Mark Schiffman, Nicolas Wentzensen
Institutions: Frederick National Laboratory for Cancer Research, National Cancer Institute, Division of Cancer Epidemiology and Genetics, Leidos Biomedical Research Inc. (United States), University of Oklahoma Health Sciences Center, Centre international de recherche sur le cancer, DDL Diagnostic Laboratory
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,763
OpenAlex ID: W2954548026