OCT 17, 2019 10:00 AM PDT

Analytical and Clinical Validation Requirements for Next Generation Sequencing Laboratory-Developed Tests

Speaker
  • Molecular Diagnostics Laboratory - Department of Laboratory Medicine and Pathology Mayo Clinic in Arizona
    Biography
      Dr. Ryan S. Robetorye received his M.D. and Ph.D. degrees from Baylor College of Medicine in Houston, Texas. He is board certified in Clinical Pathology, Hematology, and Molecular Genetic Pathology and currently works as a Consultant at the Mayo Clinic in Phoenix, Arizona. He serves as the Director of the Clinical Laboratories at the Mayo Clinic as well as the Medical Director of the Coagulation Laboratory and Co-Director of the Molecular Diagnostic-Arizona Laboratory (MDAZL). As a charter member of the College of American Pathologists (CAP) Next-Generation Sequencing Work Group, he helped to develop the first set of clinical laboratory standards for the regulation of laboratories offering NGS-based testing. This group also developed the first proficiency testing programs for clinical laboratories performing NGS tests. Dr. Robetorye is a current member of the College of American Pathologists Genomic Medicine Resource Committee and clinical laboratory Accreditation Committee. His research interests primarily involve hematological malignancies and molecular diagnostics involving gene expression profiling and next-generation sequencing.

    Abstract

    DATE: October 17, 2019

    TIME: 10:00am PDT

    Next generation sequencing (NGS) has revolutionized molecular diagnostic testing.  It is important to note that, as with many molecular diagnostic tests currently in clinical use, there are very few FDA-approved or FDA-cleared NGS assays, and thus analytical and clinical assay validation of laboratory-developed tests (LDTs) is essential to the application of NGS technology for clinical diagnostic testing.  Both analytical and clinical performance parameters must be established for NGS-based LDTs. Analytical performance parameters include accuracy, precision, reportable range, and reference interval, as well as analytical sensitivity, analytical specificity, and any other parameter that is considered important to assure the analytical performance of a particular test (e.g., specimen stability, carryover). The clinical validity and clinical utility of the testing must also be considered.  The College of American Pathologists (CAPs) Molecular Pathology Checklist requirements, universally recognized as providing best-in-class standards for clinical laboratory testing, address the analytical and clinical validation of NGS-based LDTs.

     

    Learning objectives:

    • Explain the intent of the CAP accreditation requirements for the analytical and clinical validation of NGS-based LDTs listed in the Molecular Pathology Checklist
    • Identify noncompliant validation issues that are common to many molecular laboratories performing NGS-based testing

     

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