ArticleArchives of pathology & laboratory medicine2019
Proficiency Testing of Standardized Samples Shows Very High Interlaboratory Agreement for Clinical Next-Generation Sequencing-Based Oncology Assays.
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Article in Archives of pathology & laboratory medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
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17citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 15% of its field
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Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- Resistance-Associated Mutations in Chronic Lymphocytic Leukemia Patients Treated With Novel Agents.Frontiers in oncology · 2020Pooled it
- Improved inter-lab precision after CML international scale adoption: a 15-year history of BCR::ABL1 proficiency testing.Leukemia · 2026Article
- Assessing clinical decision support system tools in precision oncology: piloting ring testing.ESMO real world data and digital oncology · 2026Article
- Diagnostic next-generation sequencing to detect MYD88 L265P in Lymphoplasmacytic lymphoma compared to ddPCR.Experimental and molecular pathology · 2025Article
- Consensus Recommendations to Optimize Testing for New Targetable Alterations in Non-Small Cell Lung Cancer.Current oncology (Toronto, Ont.) · 2022Review
- A Validation Framework for Somatic Copy Number Detection in Targeted Sequencing Panels.The Journal of molecular diagnostics : JMD · 2022Article
- Precision cancer genome testing needs proficiency testing involving all stakeholders.Scientific reports · 2022Article
- Performance assessment of DNA sequencing platforms in the ABRF Next-Generation Sequencing Study.Nature biotechnology · 2021Article
- An inter-laboratory study to investigate the impact of the bioinformatics component on microbiome analysis using mock communities.Scientific reports · 2021Article
- Germline Sequencing Improves Tumor-Only Sequencing Interpretation in a Precision Genomic Study of Patients With Pediatric Solid Tumor.JCO precision oncology · 2021Article
- Article
- The regulatory landscape of precision oncology laboratory medicine in the United States - Perspective on the past 5 years and considerations for future regulation.Practical laboratory medicine · 2020Article
- Discovery through clinical sequencing in oncology.Nature cancer · 2020Review
- Comparison of commonly used solid tumor targeted gene sequencing panels for estimating tumor mutation burden shows analytical and prognostic concordance within the cancer genome atlas cohort.Journal for immunotherapy of cancer · 2020Article
- Inter-laboratory proficiency testing scheme for tumour next-generation sequencing in Ontario: a pilot study.Current oncology (Toronto, Ont.) · 2019Article
- Sequencing of animal viruses: quality data assurance for NGS bioinformatics.Virology journal · 2019Article
- Standardization of Sequencing Coverage Depth in NGS: Recommendation for Detection of Clonal and Subclonal Mutations in Cancer Diagnostics.Frontiers in oncology · 2019Article
Corrections and comments
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Authors and funding
15 authors at 9 institutions in 2 countries.
Jason D MerkerFrom the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); the Departments of Pathology (Drs Devereaux and Montgomery, and Mr Smail) and Genetics (Dr Montgomery), Stanford University School of Medicine, and the Biomedical Informatics Program (Mr Smail), Stanford University, Stanford, California; the Department of Pathology, Massachusetts General Hospital (Dr Iafrate), and the Department of Pathology, Brigham and Women's Hospital (Drs Kim and Lindeman), Harvard University, Boston; the Departments of Pathology and Clinical Laboratory Genetics, The University Health Network and the University of Toronto, Toronto, Ontario, Canada (Dr Kamel-Reid); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Moncur); PierianDx, St Louis, Missouri (Dr Nagarajan); the Department of Global Medical Affairs, Roche, Tucson, Arizona (Dr Portier); the Departments of Hematopathology (Dr Routbort) and Pathology, Genomic Medicine, and Translational Molecular Pathology (Dr Lazar), he University of Texas MD Anderson Cancer Center, Houston (Dr Routbort); the Department of Pathology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia (Dr Surrey); and Proficiency Testing, College of American Pathologists, Northfield, Illinois (Ms Vasalos).
Kelly DevereauxFrom the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); the Departments of Pathology (Drs Devereaux and Montgomery, and Mr Smail) and Genetics (Dr Montgomery), Stanford University School of Medicine, and the Biomedical Informatics Program (Mr Smail), Stanford University, Stanford, California; the Department of Pathology, Massachusetts General Hospital (Dr Iafrate), and the Department of Pathology, Brigham and Women's Hospital (Drs Kim and Lindeman), Harvard University, Boston; the Departments of Pathology and Clinical Laboratory Genetics, The University Health Network and the University of Toronto, Toronto, Ontario, Canada (Dr Kamel-Reid); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Moncur); PierianDx, St Louis, Missouri (Dr Nagarajan); the Department of Global Medical Affairs, Roche, Tucson, Arizona (Dr Portier); the Departments of Hematopathology (Dr Routbort) and Pathology, Genomic Medicine, and Translational Molecular Pathology (Dr Lazar), he University of Texas MD Anderson Cancer Center, Houston (Dr Routbort); the Department of Pathology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia (Dr Surrey); and Proficiency Testing, College of American Pathologists, Northfield, Illinois (Ms Vasalos).
A John IafrateFrom the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); the Departments of Pathology (Drs Devereaux and Montgomery, and Mr Smail) and Genetics (Dr Montgomery), Stanford University School of Medicine, and the Biomedical Informatics Program (Mr Smail), Stanford University, Stanford, California; the Department of Pathology, Massachusetts General Hospital (Dr Iafrate), and the Department of Pathology, Brigham and Women's Hospital (Drs Kim and Lindeman), Harvard University, Boston; the Departments of Pathology and Clinical Laboratory Genetics, The University Health Network and the University of Toronto, Toronto, Ontario, Canada (Dr Kamel-Reid); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Moncur); PierianDx, St Louis, Missouri (Dr Nagarajan); the Department of Global Medical Affairs, Roche, Tucson, Arizona (Dr Portier); the Departments of Hematopathology (Dr Routbort) and Pathology, Genomic Medicine, and Translational Molecular Pathology (Dr Lazar), he University of Texas MD Anderson Cancer Center, Houston (Dr Routbort); the Department of Pathology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia (Dr Surrey); and Proficiency Testing, College of American Pathologists, Northfield, Illinois (Ms Vasalos).
Suzanne Kamel-ReidFrom the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); the Departments of Pathology (Drs Devereaux and Montgomery, and Mr Smail) and Genetics (Dr Montgomery), Stanford University School of Medicine, and the Biomedical Informatics Program (Mr Smail), Stanford University, Stanford, California; the Department of Pathology, Massachusetts General Hospital (Dr Iafrate), and the Department of Pathology, Brigham and Women's Hospital (Drs Kim and Lindeman), Harvard University, Boston; the Departments of Pathology and Clinical Laboratory Genetics, The University Health Network and the University of Toronto, Toronto, Ontario, Canada (Dr Kamel-Reid); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Moncur); PierianDx, St Louis, Missouri (Dr Nagarajan); the Department of Global Medical Affairs, Roche, Tucson, Arizona (Dr Portier); the Departments of Hematopathology (Dr Routbort) and Pathology, Genomic Medicine, and Translational Molecular Pathology (Dr Lazar), he University of Texas MD Anderson Cancer Center, Houston (Dr Routbort); the Department of Pathology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia (Dr Surrey); and Proficiency Testing, College of American Pathologists, Northfield, Illinois (Ms Vasalos).
Annette S KimFrom the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); the Departments of Pathology (Drs Devereaux and Montgomery, and Mr Smail) and Genetics (Dr Montgomery), Stanford University School of Medicine, and the Biomedical Informatics Program (Mr Smail), Stanford University, Stanford, California; the Department of Pathology, Massachusetts General Hospital (Dr Iafrate), and the Department of Pathology, Brigham and Women's Hospital (Drs Kim and Lindeman), Harvard University, Boston; the Departments of Pathology and Clinical Laboratory Genetics, The University Health Network and the University of Toronto, Toronto, Ontario, Canada (Dr Kamel-Reid); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Moncur); PierianDx, St Louis, Missouri (Dr Nagarajan); the Department of Global Medical Affairs, Roche, Tucson, Arizona (Dr Portier); the Departments of Hematopathology (Dr Routbort) and Pathology, Genomic Medicine, and Translational Molecular Pathology (Dr Lazar), he University of Texas MD Anderson Cancer Center, Houston (Dr Routbort); the Department of Pathology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia (Dr Surrey); and Proficiency Testing, College of American Pathologists, Northfield, Illinois (Ms Vasalos).
Joel T MoncurFrom the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); the Departments of Pathology (Drs Devereaux and Montgomery, and Mr Smail) and Genetics (Dr Montgomery), Stanford University School of Medicine, and the Biomedical Informatics Program (Mr Smail), Stanford University, Stanford, California; the Department of Pathology, Massachusetts General Hospital (Dr Iafrate), and the Department of Pathology, Brigham and Women's Hospital (Drs Kim and Lindeman), Harvard University, Boston; the Departments of Pathology and Clinical Laboratory Genetics, The University Health Network and the University of Toronto, Toronto, Ontario, Canada (Dr Kamel-Reid); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Moncur); PierianDx, St Louis, Missouri (Dr Nagarajan); the Department of Global Medical Affairs, Roche, Tucson, Arizona (Dr Portier); the Departments of Hematopathology (Dr Routbort) and Pathology, Genomic Medicine, and Translational Molecular Pathology (Dr Lazar), he University of Texas MD Anderson Cancer Center, Houston (Dr Routbort); the Department of Pathology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia (Dr Surrey); and Proficiency Testing, College of American Pathologists, Northfield, Illinois (Ms Vasalos).
Stephen B MontgomeryFrom the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); the Departments of Pathology (Drs Devereaux and Montgomery, and Mr Smail) and Genetics (Dr Montgomery), Stanford University School of Medicine, and the Biomedical Informatics Program (Mr Smail), Stanford University, Stanford, California; the Department of Pathology, Massachusetts General Hospital (Dr Iafrate), and the Department of Pathology, Brigham and Women's Hospital (Drs Kim and Lindeman), Harvard University, Boston; the Departments of Pathology and Clinical Laboratory Genetics, The University Health Network and the University of Toronto, Toronto, Ontario, Canada (Dr Kamel-Reid); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Moncur); PierianDx, St Louis, Missouri (Dr Nagarajan); the Department of Global Medical Affairs, Roche, Tucson, Arizona (Dr Portier); the Departments of Hematopathology (Dr Routbort) and Pathology, Genomic Medicine, and Translational Molecular Pathology (Dr Lazar), he University of Texas MD Anderson Cancer Center, Houston (Dr Routbort); the Department of Pathology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia (Dr Surrey); and Proficiency Testing, College of American Pathologists, Northfield, Illinois (Ms Vasalos).
Rakesh NagarajanFrom the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); the Departments of Pathology (Drs Devereaux and Montgomery, and Mr Smail) and Genetics (Dr Montgomery), Stanford University School of Medicine, and the Biomedical Informatics Program (Mr Smail), Stanford University, Stanford, California; the Department of Pathology, Massachusetts General Hospital (Dr Iafrate), and the Department of Pathology, Brigham and Women's Hospital (Drs Kim and Lindeman), Harvard University, Boston; the Departments of Pathology and Clinical Laboratory Genetics, The University Health Network and the University of Toronto, Toronto, Ontario, Canada (Dr Kamel-Reid); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Moncur); PierianDx, St Louis, Missouri (Dr Nagarajan); the Department of Global Medical Affairs, Roche, Tucson, Arizona (Dr Portier); the Departments of Hematopathology (Dr Routbort) and Pathology, Genomic Medicine, and Translational Molecular Pathology (Dr Lazar), he University of Texas MD Anderson Cancer Center, Houston (Dr Routbort); the Department of Pathology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia (Dr Surrey); and Proficiency Testing, College of American Pathologists, Northfield, Illinois (Ms Vasalos).
Bryce P PortierFrom the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); the Departments of Pathology (Drs Devereaux and Montgomery, and Mr Smail) and Genetics (Dr Montgomery), Stanford University School of Medicine, and the Biomedical Informatics Program (Mr Smail), Stanford University, Stanford, California; the Department of Pathology, Massachusetts General Hospital (Dr Iafrate), and the Department of Pathology, Brigham and Women's Hospital (Drs Kim and Lindeman), Harvard University, Boston; the Departments of Pathology and Clinical Laboratory Genetics, The University Health Network and the University of Toronto, Toronto, Ontario, Canada (Dr Kamel-Reid); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Moncur); PierianDx, St Louis, Missouri (Dr Nagarajan); the Department of Global Medical Affairs, Roche, Tucson, Arizona (Dr Portier); the Departments of Hematopathology (Dr Routbort) and Pathology, Genomic Medicine, and Translational Molecular Pathology (Dr Lazar), he University of Texas MD Anderson Cancer Center, Houston (Dr Routbort); the Department of Pathology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia (Dr Surrey); and Proficiency Testing, College of American Pathologists, Northfield, Illinois (Ms Vasalos).
Mark J RoutbortFrom the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); the Departments of Pathology (Drs Devereaux and Montgomery, and Mr Smail) and Genetics (Dr Montgomery), Stanford University School of Medicine, and the Biomedical Informatics Program (Mr Smail), Stanford University, Stanford, California; the Department of Pathology, Massachusetts General Hospital (Dr Iafrate), and the Department of Pathology, Brigham and Women's Hospital (Drs Kim and Lindeman), Harvard University, Boston; the Departments of Pathology and Clinical Laboratory Genetics, The University Health Network and the University of Toronto, Toronto, Ontario, Canada (Dr Kamel-Reid); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Moncur); PierianDx, St Louis, Missouri (Dr Nagarajan); the Department of Global Medical Affairs, Roche, Tucson, Arizona (Dr Portier); the Departments of Hematopathology (Dr Routbort) and Pathology, Genomic Medicine, and Translational Molecular Pathology (Dr Lazar), he University of Texas MD Anderson Cancer Center, Houston (Dr Routbort); the Department of Pathology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia (Dr Surrey); and Proficiency Testing, College of American Pathologists, Northfield, Illinois (Ms Vasalos).
Craig SmailFrom the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); the Departments of Pathology (Drs Devereaux and Montgomery, and Mr Smail) and Genetics (Dr Montgomery), Stanford University School of Medicine, and the Biomedical Informatics Program (Mr Smail), Stanford University, Stanford, California; the Department of Pathology, Massachusetts General Hospital (Dr Iafrate), and the Department of Pathology, Brigham and Women's Hospital (Drs Kim and Lindeman), Harvard University, Boston; the Departments of Pathology and Clinical Laboratory Genetics, The University Health Network and the University of Toronto, Toronto, Ontario, Canada (Dr Kamel-Reid); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Moncur); PierianDx, St Louis, Missouri (Dr Nagarajan); the Department of Global Medical Affairs, Roche, Tucson, Arizona (Dr Portier); the Departments of Hematopathology (Dr Routbort) and Pathology, Genomic Medicine, and Translational Molecular Pathology (Dr Lazar), he University of Texas MD Anderson Cancer Center, Houston (Dr Routbort); the Department of Pathology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia (Dr Surrey); and Proficiency Testing, College of American Pathologists, Northfield, Illinois (Ms Vasalos).
Lea F SurreyFrom the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); the Departments of Pathology (Drs Devereaux and Montgomery, and Mr Smail) and Genetics (Dr Montgomery), Stanford University School of Medicine, and the Biomedical Informatics Program (Mr Smail), Stanford University, Stanford, California; the Department of Pathology, Massachusetts General Hospital (Dr Iafrate), and the Department of Pathology, Brigham and Women's Hospital (Drs Kim and Lindeman), Harvard University, Boston; the Departments of Pathology and Clinical Laboratory Genetics, The University Health Network and the University of Toronto, Toronto, Ontario, Canada (Dr Kamel-Reid); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Moncur); PierianDx, St Louis, Missouri (Dr Nagarajan); the Department of Global Medical Affairs, Roche, Tucson, Arizona (Dr Portier); the Departments of Hematopathology (Dr Routbort) and Pathology, Genomic Medicine, and Translational Molecular Pathology (Dr Lazar), he University of Texas MD Anderson Cancer Center, Houston (Dr Routbort); the Department of Pathology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia (Dr Surrey); and Proficiency Testing, College of American Pathologists, Northfield, Illinois (Ms Vasalos).
Patricia VasalosFrom the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); the Departments of Pathology (Drs Devereaux and Montgomery, and Mr Smail) and Genetics (Dr Montgomery), Stanford University School of Medicine, and the Biomedical Informatics Program (Mr Smail), Stanford University, Stanford, California; the Department of Pathology, Massachusetts General Hospital (Dr Iafrate), and the Department of Pathology, Brigham and Women's Hospital (Drs Kim and Lindeman), Harvard University, Boston; the Departments of Pathology and Clinical Laboratory Genetics, The University Health Network and the University of Toronto, Toronto, Ontario, Canada (Dr Kamel-Reid); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Moncur); PierianDx, St Louis, Missouri (Dr Nagarajan); the Department of Global Medical Affairs, Roche, Tucson, Arizona (Dr Portier); the Departments of Hematopathology (Dr Routbort) and Pathology, Genomic Medicine, and Translational Molecular Pathology (Dr Lazar), he University of Texas MD Anderson Cancer Center, Houston (Dr Routbort); the Department of Pathology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia (Dr Surrey); and Proficiency Testing, College of American Pathologists, Northfield, Illinois (Ms Vasalos).
Alexander J LazarFrom the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); the Departments of Pathology (Drs Devereaux and Montgomery, and Mr Smail) and Genetics (Dr Montgomery), Stanford University School of Medicine, and the Biomedical Informatics Program (Mr Smail), Stanford University, Stanford, California; the Department of Pathology, Massachusetts General Hospital (Dr Iafrate), and the Department of Pathology, Brigham and Women's Hospital (Drs Kim and Lindeman), Harvard University, Boston; the Departments of Pathology and Clinical Laboratory Genetics, The University Health Network and the University of Toronto, Toronto, Ontario, Canada (Dr Kamel-Reid); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Moncur); PierianDx, St Louis, Missouri (Dr Nagarajan); the Department of Global Medical Affairs, Roche, Tucson, Arizona (Dr Portier); the Departments of Hematopathology (Dr Routbort) and Pathology, Genomic Medicine, and Translational Molecular Pathology (Dr Lazar), he University of Texas MD Anderson Cancer Center, Houston (Dr Routbort); the Department of Pathology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia (Dr Surrey); and Proficiency Testing, College of American Pathologists, Northfield, Illinois (Ms Vasalos).
Neal I LindemanFrom the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); the Departments of Pathology (Drs Devereaux and Montgomery, and Mr Smail) and Genetics (Dr Montgomery), Stanford University School of Medicine, and the Biomedical Informatics Program (Mr Smail), Stanford University, Stanford, California; the Department of Pathology, Massachusetts General Hospital (Dr Iafrate), and the Department of Pathology, Brigham and Women's Hospital (Drs Kim and Lindeman), Harvard University, Boston; the Departments of Pathology and Clinical Laboratory Genetics, The University Health Network and the University of Toronto, Toronto, Ontario, Canada (Dr Kamel-Reid); the Department of Pathology, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Moncur); PierianDx, St Louis, Missouri (Dr Nagarajan); the Department of Global Medical Affairs, Roche, Tucson, Arizona (Dr Portier); the Departments of Hematopathology (Dr Routbort) and Pathology, Genomic Medicine, and Translational Molecular Pathology (Dr Lazar), he University of Texas MD Anderson Cancer Center, Houston (Dr Routbort); the Department of Pathology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia (Dr Surrey); and Proficiency Testing, College of American Pathologists, Northfield, Illinois (Ms Vasalos).
La Roche College · USHarvard University · USMassachusetts General Hospital · USUniversity of North Carolina at Chapel Hill · USUniversity of Pennsylvania · USChildren's Hospital of Philadelphia · USPhiladelphia University · USUniversity of Toronto · CAWalter Reed National Military Medical Center · US
Funding
Biomedical Data Science Graduate Training at StanfordT32LM012409 · NLM · STANFORD UNIVERSITY · PI PLEVRITIS, SYLVIA KATINA · 2016 to 2020
$1.5MNLM NIH HHS T32 LM012409
Abstract
CONTEXT.—: Next-generation sequencing-based assays are being increasingly used in the clinical setting for the detection of somatic variants in solid tumors, but limited data are available regarding the interlaboratory performance of these assays. OBJECTIVE.—: To examine proficiency testing data from the initial College of American Pathologists (CAP) Next-Generation Sequencing Solid Tumor survey to report on laboratory performance. DESIGN.—: CAP proficiency testing results from 111 laboratories were analyzed for accuracy and associated assay performance characteristics. RESULTS.—: The overall accuracy observed for all variants was 98.3%. Rare false-negative results could not be attributed to sequencing platform, selection method, or other assay characteristics. The median and average of the variant allele fractions reported by the laboratories were within 10% of those orthogonally determined by digital polymerase chain reaction for each variant. The median coverage reported at the variant sites ranged from 1922 to 3297. CONCLUSIONS.—: Laboratories demonstrated an overall accuracy of greater than 98% with high specificity when examining 10 clinically relevant somatic single-nucleotide variants with a variant allele fraction of 15% or greater. These initial data suggest excellent performance, but further ongoing studies are needed to evaluate the performance of lower variant allele fractions and additional variant types.
Indexed as
Laboratory Proficiency TestingHigh-Throughput Nucleotide SequencingHumansMedical OncologyPathology, ClinicalReproducibility of Results
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