Integration of Technical, Bioinformatic, and Variant Assessment Approaches in the Validation of a Targeted Next-Generation Sequencing Panel for Myeloid Malignancies.

Context.--Detection of variants in hematologic malignancies is increasingly important because of a growing number of variants impacting diagnosis, prognosis, and treatment response, and as potential therapeutic targets. The use of next-generation sequencing technologies to detect variants in hematol...

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Published in:Archives of Pathology & Laboratory Medicine Vol. 141; no. 6; pp. 759 - 776
Main Authors: Thomas, Mariam, Sukhai, Mahadeo A., Zhang, Tong, Dolatshahi, Roozbeh, Harbi, Djamel, Garg, Swati, Misyura, Maksym, Pugh, Trevor, Stockley, Tracy L., Kamel-Reid, Suzanne
Format: research tables/charts Journal Article
Published: College of American Pathologists Jun2017
Online Access:View this record in EBSCOhost
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      dt: Jun2017
      vid: 141
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      pub: College of American Pathologists
      place: Northfield, Illinois
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        10.5858/arpa.2016-0547-RA
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        atl: Integration of Technical, Bioinformatic, and Variant Assessment Approaches in the Validation of a Targeted Next-Generation Sequencing Panel for Myeloid Malignancies.
      aug:
        au:
          Thomas, Mariam
          Sukhai, Mahadeo A.
          Zhang, Tong
          Dolatshahi, Roozbeh
          Harbi, Djamel
          Garg, Swati
          Misyura, Maksym
          Pugh, Trevor
          Stockley, Tracy L.
          Kamel-Reid, Suzanne
        affil: Laboratory Medicine Program, Advanced Molecular Diagnostics Laboratory, Departments of Pathology and Genetics, University Health Network, Toronto, Ontario, Canada
      sug:
        subj:
          Bioinformatics
          Technology
          Leukemia, Myeloid
          Genetic Screening Methods
          Sequence Analysis
          Hematologic Neoplasms Diagnosis
          Hematologic Neoplasms Physiopathology
          Outcomes (Health Care)
          Tumor Markers, Biological
          Diffusion of Innovation
          Genes
          Data Collection
          Data Analysis Software
          Funding Source
      ab: Context.--Detection of variants in hematologic malignancies is increasingly important because of a growing number of variants impacting diagnosis, prognosis, and treatment response, and as potential therapeutic targets. The use of next-generation sequencing technologies to detect variants in hematologic malignancies in a clinical diagnostic laboratory setting allows for efficient identification of routinely tested markers in multiple genes simultaneously, as well as the identification of novel and rare variants in other clinically relevant genes. Objective.--To apply a systematic approach to evaluate and validate a commercially available next-generation sequencing panel (TruSight Myeloid Sequencing Panel, Illumina, San Diego, California) targeting 54 genes. In this manuscript, we focused on the parameters that were used to evaluate assay performance characteristics. Data Sources.--Analytical validation was performed using samples containing known variants that had been identified previously. Cases were selected from different disease types, with variants in a range of genes. Panel performance characteristics were assessed and genomic regions requiring additional analysis or wet-bench approaches identified. Conclusions.--We validated the performance characteristics of a myeloid next-generation sequencing panel for detection of variants. The TruSight Myeloid Sequencing Panel covers more than 95% of target regions with depth greater than 5003. However, because of unique variant types such as large insertions or deletions or genomic regions of high GC content, variants in CEBPA, FLT3, and CALR required supplementation with non--next-generation sequencing assays or with informatics approaches to address deficiencies in performance. The use of multiple bioinformatics approaches (2 variant callers and informatics scripts) allows for maximizing calling of true positives, while identifying limitations in using either method alone.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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