Genome Biology (Apr 2021)
Cross-oncopanel study reveals high sensitivity and accuracy with overall analytical performance depending on genomic regions
- Binsheng Gong,
- Dan Li,
- Rebecca Kusko,
- Natalia Novoradovskaya,
- Yifan Zhang,
- Shangzi Wang,
- Carlos Pabón-Peña,
- Zhihong Zhang,
- Kevin Lai,
- Wanshi Cai,
- Jennifer S. LoCoco,
- Eric Lader,
- Todd A. Richmond,
- Vinay K. Mittal,
- Liang-Chun Liu,
- Donald J. Johann,
- James C. Willey,
- Pierre R. Bushel,
- Ying Yu,
- Chang Xu,
- Guangchun Chen,
- Daniel Burgess,
- Simon Cawley,
- Kristina Giorda,
- Nathan Haseley,
- Fujun Qiu,
- Katherine Wilkins,
- Hanane Arib,
- Claire Attwooll,
- Kevin Babson,
- Longlong Bao,
- Wenjun Bao,
- Anne Bergstrom Lucas,
- Hunter Best,
- Ambica Bhandari,
- Halil Bisgin,
- James Blackburn,
- Thomas M. Blomquist,
- Lisa Boardman,
- Blake Burgher,
- Daniel J. Butler,
- Chia-Jung Chang,
- Alka Chaubey,
- Tao Chen,
- Marco Chierici,
- Christopher R. Chin,
- Devin Close,
- Jeffrey Conroy,
- Jessica Cooley Coleman,
- Daniel J. Craig,
- Erin Crawford,
- Angela del Pozo,
- Ira W. Deveson,
- Daniel Duncan,
- Agda Karina Eterovic,
- Xiaohui Fan,
- Jonathan Foox,
- Cesare Furlanello,
- Abhisek Ghosal,
- Sean Glenn,
- Meijian Guan,
- Christine Haag,
- Xinyi Hang,
- Scott Happe,
- Brittany Hennigan,
- Jennifer Hipp,
- Huixiao Hong,
- Kyle Horvath,
- Jianhong Hu,
- Li-Yuan Hung,
- Mirna Jarosz,
- Jennifer Kerkhof,
- Benjamin Kipp,
- David Philip Kreil,
- Paweł Łabaj,
- Pablo Lapunzina,
- Peng Li,
- Quan-Zhen Li,
- Weihua Li,
- Zhiguang Li,
- Yu Liang,
- Shaoqing Liu,
- Zhichao Liu,
- Charles Ma,
- Narasimha Marella,
- Rubén Martín-Arenas,
- Dalila B. Megherbi,
- Qingchang Meng,
- Piotr A. Mieczkowski,
- Tom Morrison,
- Donna Muzny,
- Baitang Ning,
- Barbara L. Parsons,
- Cloud P. Paweletz,
- Mehdi Pirooznia,
- Wubin Qu,
- Amelia Raymond,
- Paul Rindler,
- Rebecca Ringler,
- Bekim Sadikovic,
- Andreas Scherer,
- Egbert Schulze,
- Robert Sebra,
- Rita Shaknovich,
- Qiang Shi,
- Tieliu Shi,
- Juan Carlos Silla-Castro,
- Melissa Smith,
- Mario Solís López,
- Ping Song,
- Daniel Stetson,
- Maya Strahl,
- Alan Stuart,
- Julianna Supplee,
- Philippe Szankasi,
- Haowen Tan,
- Lin-ya Tang,
- Yonghui Tao,
- Shraddha Thakkar,
- Danielle Thierry-Mieg,
- Jean Thierry-Mieg,
- Venkat J. Thodima,
- David Thomas,
- Boris Tichý,
- Nikola Tom,
- Elena Vallespin Garcia,
- Suman Verma,
- Kimbley Walker,
- Charles Wang,
- Junwen Wang,
- Yexun Wang,
- Zhining Wen,
- Valtteri Wirta,
- Leihong Wu,
- Chunlin Xiao,
- Wenzhong Xiao,
- Shibei Xu,
- Mary Yang,
- Jianming Ying,
- Shun H. Yip,
- Guangliang Zhang,
- Sa Zhang,
- Meiru Zhao,
- Yuanting Zheng,
- Xiaoyan Zhou,
- Christopher E. Mason,
- Timothy Mercer,
- Weida Tong,
- Leming Shi,
- Wendell Jones,
- Joshua Xu
Affiliations
- Binsheng Gong
- Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration
- Dan Li
- Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration
- Rebecca Kusko
- Immuneering Corporation
- Natalia Novoradovskaya
- Agilent Technologies
- Yifan Zhang
- Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration
- Shangzi Wang
- State Key Laboratory of Genetic Engineering, School of Life Sciences and Shanghai Cancer Hospital/Cancer Institute, Fudan University
- Carlos Pabón-Peña
- Agilent Technologies
- Zhihong Zhang
- Research and Development, Burning Rock Biotech
- Kevin Lai
- Bioinformatics, Integrated DNA Technologies, Inc.
- Wanshi Cai
- iGeneTech
- Jennifer S. LoCoco
- Illumina Inc.
- Eric Lader
- Research and Development, QIAGEN Sciences Inc.
- Todd A. Richmond
- Market & Application Development Bioinformatics, Roche Sequencing Solutions Inc.
- Vinay K. Mittal
- Thermo Fisher Scientific
- Liang-Chun Liu
- Clinical Diagnostic Division, Thermo Fisher Scientific
- Donald J. Johann
- Winthrop P Rockefeller Cancer Institute, University of Arkansas for Medical Sciences
- James C. Willey
- Departments of Medicine, Pathology, and Cancer Biology, College of Medicine and Life Sciences, University of Toledo Health Sciences Campus
- Pierre R. Bushel
- National Institute of Environmental Health Sciences
- Ying Yu
- State Key Laboratory of Genetic Engineering, School of Life Sciences and Shanghai Cancer Hospital/Cancer Institute, Fudan University
- Chang Xu
- Research and Development, QIAGEN Sciences Inc.
- Guangchun Chen
- Department of Immunology, Genomics and Microarray Core Facility, University of Texas Southwestern Medical Center
- Daniel Burgess
- Research and Development, Roche Sequencing Solutions Inc.
- Simon Cawley
- Clinical Sequencing Division, Thermo Fisher Scientific
- Kristina Giorda
- Marketing, Integrated DNA Technologies, Inc.
- Nathan Haseley
- Illumina Inc.
- Fujun Qiu
- Research and Development, Burning Rock Biotech
- Katherine Wilkins
- Agilent Technologies
- Hanane Arib
- Icahn Institute and Dept. of Genetics and Genomic Sciences Icahn School of Medicine at Mount Sinai
- Claire Attwooll
- Illumina Inc.
- Kevin Babson
- Greenwood Genetic Center
- Longlong Bao
- Department of Pathology, Fudan University Shanghai Cancer Center, Fudan University
- Wenjun Bao
- JMP Life Sciences, SAS Institute Inc.
- Anne Bergstrom Lucas
- Agilent Technologies
- Hunter Best
- Departments of Pathology and Pediatrics, University of Utah School of Medicine
- Ambica Bhandari
- ResearchDx, Inc.
- Halil Bisgin
- Department of Computer Science, Engineering and Physics, University of Michigan-Flint
- James Blackburn
- Garvan Institute of Medical Research
- Thomas M. Blomquist
- Department of Pathology, College of Medicine and Life Sciences, The University of Toledo
- Lisa Boardman
- Division of Gastroenterology and Hepatology, Mayo Clinic
- Blake Burgher
- OmniSeq
- Daniel J. Butler
- Department of Physiology and Biophysics, Weill Cornell Medicine, Cornell University
- Chia-Jung Chang
- Stanford Genome Technology Center, Stanford University
- Alka Chaubey
- Greenwood Genetic Center
- Tao Chen
- Division of Genetic and Molecular Toxicology, National Center for Toxicological Research, US Food and Drug Administration
- Marco Chierici
- Fondazione Bruno Kessler
- Christopher R. Chin
- Department of Physiology and Biophysics, Weill Cornell Medicine, Cornell University
- Devin Close
- R&D Genomics MPS, Institute for Clinical and Experimental Pathology ARUP Laboratories
- Jeffrey Conroy
- OmniSeq
- Jessica Cooley Coleman
- Greenwood Genetic Center
- Daniel J. Craig
- Department of Medicine, College of Medicine and Life Sciences, The University of Toledo
- Erin Crawford
- Department of Medicine, College of Medicine and Life Sciences, The University of Toledo
- Angela del Pozo
- Institute of Medical and Molecular Genetics (INGEMM), Hospital Universitario La Paz, CIBERER Instituto de Salud Carlos III
- Ira W. Deveson
- Kinghorn Centre for Clinical Genomics, Garvan Institute of Medical Research
- Daniel Duncan
- Cancer Genetics Inc
- Agda Karina Eterovic
- Institute for Personalized Cancer Therapy, MD Anderson Cancer Center
- Xiaohui Fan
- Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University
- Jonathan Foox
- Department of Physiology and Biophysics, Weill Cornell Medicine, Cornell University
- Cesare Furlanello
- Fondazione Bruno Kessler
- Abhisek Ghosal
- ResearchDx, Inc.
- Sean Glenn
- OmniSeq
- Meijian Guan
- JMP Life Sciences, SAS Institute Inc.
- Christine Haag
- Molecular Laboratory, Prof. F. Raue
- Xinyi Hang
- iGeneTech
- Scott Happe
- Agilent Technologies
- Brittany Hennigan
- Greenwood Genetic Center
- Jennifer Hipp
- Department of Pathology, Strata Oncology, Inc.
- Huixiao Hong
- Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration
- Kyle Horvath
- ResearchDx, Inc.
- Jianhong Hu
- Human Genome Sequencing Center, Baylor College of Medicine
- Li-Yuan Hung
- Massachusetts General Hospital, Harvard Medical School
- Mirna Jarosz
- NGS Products and Services, Integrated DNA Technologies, Inc.
- Jennifer Kerkhof
- Molecular Genetics Laboratory, Molecular Diagnostics Division, London Health Sciences Centre
- Benjamin Kipp
- Division of Anatomic Pathology, Mayo Clinic
- David Philip Kreil
- Bioinformatics Research, Institute of Molecular Biotechnology, Boku University Vienna
- Paweł Łabaj
- Małopolska Centre of Biotechnology, Jagiellonian University
- Pablo Lapunzina
- EATRIS ERIC- European Infrastructure for Translational Medicine
- Peng Li
- Massachusetts General Hospital, Harvard Medical School
- Quan-Zhen Li
- Department of Immunology, Genomics and Microarray Core Facility, University of Texas Southwestern Medical Center
- Weihua Li
- Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences
- Zhiguang Li
- Center of Genome and Personalized Medicine, Institute of Cancer Stem Cell, Dalian Medical University
- Yu Liang
- Geneis
- Shaoqing Liu
- GeneSmile Ltd Co., Jiangsu Cancer Hospital
- Zhichao Liu
- Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration
- Charles Ma
- Cancer Genetics Inc
- Narasimha Marella
- Cancer Genetics Inc
- Rubén Martín-Arenas
- Genycell Biotech España, Calle Garrido Atienza
- Dalila B. Megherbi
- CMINDS Research Center, Department of Electrical and Computer Engineering, College of Engineering, University of Massachusetts Lowell
- Qingchang Meng
- Human Genome Sequencing Center, Baylor College of Medicine
- Piotr A. Mieczkowski
- Department of Genetics, University of North Carolina
- Tom Morrison
- Accugenomics, Inc.
- Donna Muzny
- Human Genome Sequencing Center, Baylor College of Medicine
- Baitang Ning
- Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration
- Barbara L. Parsons
- Division of Genetic and Molecular Toxicology, National Center for Toxicological Research, US Food and Drug Administration
- Cloud P. Paweletz
- Translational Research Laboratory, Belfer Center for Applied Cancer Science, Dana-Farber Cancer Institute
- Mehdi Pirooznia
- Bioinformatics and Computational Biology Laboratory, National Heart Lung and Blood Institute, National Institutes of Health
- Wubin Qu
- iGeneTech
- Amelia Raymond
- Astrazeneca Pharmaceuticals
- Paul Rindler
- R&D Genomics MPS, Institute for Clinical and Experimental Pathology ARUP Laboratories
- Rebecca Ringler
- ResearchDx, Inc.
- Bekim Sadikovic
- Molecular Genetics Laboratory, Molecular Diagnostics Division, London Health Sciences Centre
- Andreas Scherer
- EATRIS ERIC- European Infrastructure for Translational Medicine
- Egbert Schulze
- Laboratory for Molecular Genetics, Endocrine Practice
- Robert Sebra
- Icahn Institute and Dept. of Genetics and Genomic Sciences Icahn School of Medicine at Mount Sinai
- Rita Shaknovich
- Cancer Genetics Inc
- Qiang Shi
- Division of Systems Biology, National Center for Toxicological Research, US Food and Drug Administration
- Tieliu Shi
- Center for Bioinformatics and Computational Biology, and the Institute of Biomedical Sciences, School of Life Sciences, East China Normal University
- Juan Carlos Silla-Castro
- National Centre for Cardiovascular Research (CNIC)
- Melissa Smith
- Icahn Institute and Dept. of Genetics and Genomic Sciences Icahn School of Medicine at Mount Sinai
- Mario Solís López
- Institute of Medical and Molecular Genetics (INGEMM), Hospital Universitario La Paz, CIBERER Instituto de Salud Carlos III
- Ping Song
- Institute for Personalized Cancer Therapy, MD Anderson Cancer Center
- Daniel Stetson
- Astrazeneca Pharmaceuticals
- Maya Strahl
- Icahn Institute and Dept. of Genetics and Genomic Sciences Icahn School of Medicine at Mount Sinai
- Alan Stuart
- Molecular Genetics Laboratory, Molecular Diagnostics Division, London Health Sciences Centre
- Julianna Supplee
- Translational Research Laboratory, Belfer Center for Applied Cancer Science, Dana-Farber Cancer Institute
- Philippe Szankasi
- R&D Genomics MPS, Institute for Clinical and Experimental Pathology ARUP Laboratories
- Haowen Tan
- Primbio Genes Biotechnology
- Lin-ya Tang
- Institute for Personalized Cancer Therapy, MD Anderson Cancer Center
- Yonghui Tao
- Department of Pathology, Fudan University Shanghai Cancer Center, Fudan University
- Shraddha Thakkar
- Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration
- Danielle Thierry-Mieg
- National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health
- Jean Thierry-Mieg
- National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health
- Venkat J. Thodima
- Cancer Genetics Inc
- David Thomas
- St Vincent’s Clinical School, University of New South Wales
- Boris Tichý
- EATRIS ERIC- European Infrastructure for Translational Medicine
- Nikola Tom
- EATRIS ERIC- European Infrastructure for Translational Medicine
- Elena Vallespin Garcia
- Institute of Medical and Molecular Genetics (INGEMM), Hospital Universitario La Paz, CIBERER Instituto de Salud Carlos III
- Suman Verma
- ResearchDx, Inc.
- Kimbley Walker
- Human Genome Sequencing Center, Baylor College of Medicine
- Charles Wang
- Center for Genomics, School of Medicine, Loma Linda University
- Junwen Wang
- Center for Individualized Medicine, Mayo Clinic
- Yexun Wang
- Research and Development, QIAGEN Sciences Inc.
- Zhining Wen
- College of Chemistry, Sichuan University
- Valtteri Wirta
- Science for Life Laboratory, Karolinska Institutet
- Leihong Wu
- Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration
- Chunlin Xiao
- National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health
- Wenzhong Xiao
- Stanford Genome Technology Center, Stanford University
- Shibei Xu
- Department of Biostatistics, Columbia Mailman School of Public Health
- Mary Yang
- Department of Information Science, University of Arkansas at Little Rock
- Jianming Ying
- Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences
- Shun H. Yip
- Center for Individualized Medicine, Mayo Clinic
- Guangliang Zhang
- Clinical Laboratory, Burning Rock Biotech
- Sa Zhang
- Clinical Laboratory, Burning Rock Biotech
- Meiru Zhao
- Geneplus, PKUCare Industrial Park
- Yuanting Zheng
- State Key Laboratory of Genetic Engineering, School of Life Sciences and Shanghai Cancer Hospital/Cancer Institute, Fudan University
- Xiaoyan Zhou
- Department of Pathology, Fudan University Shanghai Cancer Center, Fudan University
- Christopher E. Mason
- Department of Physiology and Biophysics, Weill Cornell Medicine, Cornell University
- Timothy Mercer
- Australian Institute of Bioengineering and Nanotechnology, University of Queensland
- Weida Tong
- Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration
- Leming Shi
- State Key Laboratory of Genetic Engineering, School of Life Sciences and Shanghai Cancer Hospital/Cancer Institute, Fudan University
- Wendell Jones
- Q2 Solutions - EA Genomics
- Joshua Xu
- Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration
- DOI
- https://doi.org/10.1186/s13059-021-02315-0
- Journal volume & issue
-
Vol. 22,
no. 1
pp. 1 – 23
Abstract
Abstract Background Targeted sequencing using oncopanels requires comprehensive assessments of accuracy and detection sensitivity to ensure analytical validity. By employing reference materials characterized by the U.S. Food and Drug Administration-led SEquence Quality Control project phase2 (SEQC2) effort, we perform a cross-platform multi-lab evaluation of eight Pan-Cancer panels to assess best practices for oncopanel sequencing. Results All panels demonstrate high sensitivity across targeted high-confidence coding regions and variant types for the variants previously verified to have variant allele frequency (VAF) in the 5–20% range. Sensitivity is reduced by utilizing VAF thresholds due to inherent variability in VAF measurements. Enforcing a VAF threshold for reporting has a positive impact on reducing false positive calls. Importantly, the false positive rate is found to be significantly higher outside the high-confidence coding regions, resulting in lower reproducibility. Thus, region restriction and VAF thresholds lead to low relative technical variability in estimating promising biomarkers and tumor mutational burden. Conclusion This comprehensive study provides actionable guidelines for oncopanel sequencing and clear evidence that supports a simplified approach to assess the analytical performance of oncopanels. It will facilitate the rapid implementation, validation, and quality control of oncopanels in clinical use.
Keywords
- Oncopanel sequencing
- Target enrichment
- Molecular diagnostics
- Reproducibility
- Analytical performance
- Precision medicine