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Tiered Somatic Variant Classification Adoption Has Increased Worldwide With Some Practice Differences Based on

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The 2017 tier classification guideline is widely adopted by molecular pathology laboratories for somatic variant interpretation. Most users are satisfied, indicating good reproducibility, though modifications could enhance clinical utility.

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Area of Science:

  • Molecular Pathology
  • Genomics
  • Clinical Diagnostics

Background:

  • The 2017 Association for Molecular Pathology/American Society of Clinical Oncology/College of American Pathologists (CAP) guideline standardizes somatic variant interpretation.
  • Next-generation sequencing (NGS) is crucial for identifying these variants in clinical settings.

Purpose of the Study:

  • To assess the adoption and performance of the 2017 tier classification guideline in laboratories performing somatic NGS.
  • To identify areas for improvement in future guideline revisions.

Main Methods:

  • A survey was distributed to laboratories participating in CAP proficiency testing for solid tumors (NGSST) and hematologic malignancies (NGSHM).
  • Data collected included guideline usage, modifications, satisfaction, and perceived reproducibility.

Main Results:

  • Over 64% of laboratories use tier classification systems, with 84.9% (NGSST) and 73.6% (NGSHM) using the 2017 guideline.
  • Most users (over 70%) reported satisfaction and high reproducibility.
  • Future revisions should consider variants for disease monitoring and germline variants.

Conclusions:

  • The 2017 guideline shows significant adoption and user satisfaction in CAP-accredited laboratories.
  • Modifications focusing on disease monitoring and germline variants could enhance the guideline's quality, reproducibility, and clinical utility.