Mismatch Repair and Microsatellite Instability Testing for Immune Checkpoint Inhibitor Therapy

Document Overview

Document Title

Mismatch Repair and Microsatellite Instability Testing for Immune Checkpoint Inhibitor Therapy

Authoring Society

College of American Pathologists

Endorsing Society

Association for Molecular Pathology

Document Publication Date

Aug 2, 2022

Page Last Reviewed/Updated

May 5, 2026

Document Type

Guideline

Country of Publication

United States

Full Text Freely Available

Yes

Full Text Guideline

aplm.kglmeridian.com/view/journals/arpa/146/10/article-p1194.xml

Source Citation

Bartley AN, Mills AM, Konnick E, Overman M, Ventura CB, Souter L, Colasacco C, Stadler ZK, Kerr S, Howitt BE, Hampel H, Adams SF, Johnson W, Magi-Galluzzi C, Sepulveda AR, Broaddus RR. Mismatch Repair and Microsatellite Instability Testing for Immune Checkpoint Inhibitor Therapy. Arch Pathol Lab Med. 2022 Aug 3. doi: 10.5858/arpa.2021-0632-CP. Epub ahead of print. PMID: 35920830.

Supplemental Implementation Resources

• Visual Abstract
• Slide Set
• Quick-Reference Guide
• Quick-Reference Guide

Document Scope, Criteria, and Use Cases

Document Objectives

The US Food and Drug Administration (FDA) approved immune checkpoint inhibitor therapy for patients with advanced solid tumors that have DNA mismatch repair defects or high levels of microsatellite instability; however, the FDA provided no guidance on which specific clinical assays should be used to determine mismatch repair status. The objective is to develop an evidence-based guideline to identify the optimal clinical laboratory test to identify defects in DNA mismatch repair in patients with solid tumor malignancies who are being considered for immune checkpoint inhibitor therapy.

Scope

Assessment and Screening, Diagnosis

Diseases/Conditions (MeSH)

D053843 - DNA Mismatch Repair

D000082082 - Immune Checkpoint Inhibitors

D053843 - DNA Mismatch Repair

D000082082 - Immune Checkpoint Inhibitors

Keywords

Microsatellite Instability Testing, Mismatch repair, immune checkpoint inhibitor (ICI)

Inclusion Criteria

Male, Female, Adolescent, Adult, Child, Older Adult

Health Care Settings

Laboratory Services, Outpatient

Intended Users

Nurse, Nurse Practitioner, Physician, Physician Assistant

Recommendation Development Processes & Methodology

Supplemental Methodology Resources

Data Supplement Methodology Supplement

Number of Source Documents

114

Literature Search Start Date

Monday, December 31, 2007

Literature Search End Date

Monday, March 29, 2021

Includes peer/external review process?

Yes

Includes public comment process?

No

Methodologist involvement?

Yes

Patient involvement?

No

Includes multi-disciplinary group?

Yes

Includes systematic review?

Yes

Grades quality of strength of evidence?

Yes

Grades quality of strength of recommendation?

Yes

Discloses funding source?

Yes

Discloses conflicts of interest?

Yes

Includes benefits/harms analysis with recommendations?

No