Tiered Somatic Variant Classification Adoption Has Increased Worldwide With Some Practice Differences Based on Location and Institutional Setting-Reference-Cited by-同舟云学术

Tiered Somatic Variant Classification Adoption Has Increased Worldwide With Some Practice Differences Based on Location and Institutional Setting

Published:2022-01-03 Issue:7 Volume:146 Page:822-832
ISSN:1543-2165
Container-title:Archives of Pathology & Laboratory Medicine
language:en
Short-container-title:

Author:

Bruehl Frido K.¹,Kim Annette S.²,Li Marilyn M.³,Lindeman Neal I.²,Moncur Joel T.⁴,Souers Rhona J.⁵,Vasalos Patricia⁶,Voelkerding Karl V.⁷,Xian Rena R.⁸,Surrey Lea F.³

Affiliation:

1. From Robert J. Tomsich Pathology and Laboratory Medicine Institute, Cleveland Clinic, Cleveland, Ohio (Bruehl).

2. From the Departments of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (Kim, Lindeman).

3. From the Department of Pathology and Laboratory Medicine, Perelman School of Medicine, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania (Li, Surrey).

4. From the Joint Pathology Center, Office of the Director, Silver Spring, Maryland (Moncur).

5. From the Biostatistics Department (Souers), College of American Pathologists, Northfield, Illinois.

6. From the Proficiency Testing (Vasalos), College of American Pathologists, Northfield, Illinois.

7. From Voelkerding Consulting, Salt Lake City, Utah (Voelkerding).

8. From the Department of Pathology and Oncology, School of Medicine, Johns Hopkins University, Baltimore, Maryland (Xian).

Abstract

Context.— The 2017 Association for Molecular Pathology/American Society of Clinical Oncology/College of American Pathologists (CAP) tier classification guideline provides a framework to standardize interpretation and reporting of somatic variants. Objective.— To evaluate the adoption and performance of the 2017 guideline among laboratories performing somatic next-generation sequencing (NGS). Design.— A survey was distributed to laboratories participating in NGS CAP proficiency testing for solid tumors (NGSST) and hematologic malignancies (NGSHM). Results.— Worldwide, 64.4% (152 of 236) of NGSST and 66.4% (87 of 131) of NGSHM participants used tier classification systems, of which the 2017 guideline was used by 84.9% (129 of 152) of NGSST and 73.6% (64 of 87) of NGSHM participants. The 2017 guideline was modified by 24.4% (30 of 123) of NGSST and 21.7% (13 of 60) of NGSHM laboratories. Laboratories implementing the 2017 guideline were satisfied or very satisfied (74.2% [89 of 120] NGSST and 69.5% [41 of 59] NGSHM), and the impression of tier classification reproducibility was high (mean of 3.9 [NGSST] and 3.6 [NGSHM] on a 5-point scale). Of nonusers, 35.2% (38 of 108) of NGSST and 39.4% (26 of 66) of NGSHM laboratories were planning implementation. For future guideline revisions, respondents favored including variants to monitor disease (63.9% [78 of 122] NGSST, 80.0% [48 of 60] NGSHM) and germline variants (55.3% [63 of 114] NGSST, 75.0% [45 of 60] NGSHM). Additional subtiers were not favored by academic laboratories compared to nonacademic laboratories (P < .001 NGSST and P = .02 NGSHM). Conclusions.— The 2017 guideline has been implemented by more than 50.0% of CAP laboratories. While most laboratories using the 2017 guideline report satisfaction, thoughtful guideline modifications may further enhance the quality, reproducibility, and clinical utility of the 2017 guideline for tiered somatic variant classification.

Publisher

Archives of Pathology and Laboratory Medicine

Subject

Medical Laboratory Technology,General Medicine,Pathology and Forensic Medicine

Link

https://meridian.allenpress.com/aplm/article-pdf/146/7/822/3126524/i1543-2165-146-7-822.pdf

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