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Considerations of developing an NGS assay for clinical applications in precision oncology: The NCI-MATCH NGS assay experience

  1. Author:
    Lih, Chih-Jian
    Takebe, Naoko

  2. Author Address

    Molecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, MD., Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, MD.,
    1. Year: 2017
    2. Date: May - Jun
  2. Journal: Current problems in cancer
    1. 41
    2. 3
    3. Pages: 201-211
  4. Type of Article: Article
  1. Abstract:

    Next generation sequencing (NGS) technologies have been widely adapted in clinical oncology by utilizing the profiled genetic mutation information to select patients and to guide the choice of target therapy. To fulfill the regulatory compliance, development of an NGS assay that will be used in clinical trials requires an analytical validation to meet its intend clinical use. NCI-MATCH trial is the largest precision oncology basket trial which uses a single NGS assay (NCI-MATHC NGS assay) to screen the actionable mutations in 6000 patients, who have relapsed/refractory solid tumors and lymphomas after standard systemic treatment, and assigns matched treatment. This article reviews on the critical considerations during development and validation of NGS assays as an investigational device for genomic based clinical trials and provides the experiences from the development of NCI-MATCH NGS assay. Copyright © 2017. Published by Elsevier Inc.

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External Sources

  1. View Full Text
  2. DOI: 10.1016/j.currproblcancer.2017.05.003
  3. PMID: 28625332
  4. View record in Web of Science®
  5. WOS: 000404315900006

Library Notes

  1. Fiscal Year: FY2016-2017
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