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A Highly Sensitive Pan-Cancer Test for Microsatellite Instability.

Jeffery W Bacher1, Eshwar B Udho2, Ethan E Strauss3

  • 1R&D Clinical Diagnostics, Promega Corporation, Madison, Wisconsin; Department of Medicine, University of Wisconsin, Madison, Wisconsin.

The Journal of Molecular Diagnostics : JMD
|August 6, 2023
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Summary
This summary is machine-generated.

A new multiplex assay using long mononucleotide repeat (LMR) markers enhances microsatellite instability (MSI) detection across various cancers. This improved assay aids in identifying Lynch syndrome and predicting immunotherapy response.

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Area of Science:

  • Oncology
  • Molecular Diagnostics
  • Genetics

Background:

  • Microsatellite instability (MSI) is a crucial biomarker in cancer, initially for Lynch syndrome and now for immunotherapy response.
  • Accurate MSI detection is vital for personalized cancer treatment strategies.
  • Existing methods require enhancement for broader cancer type applicability and sensitivity.

Purpose of the Study:

  • To develop and validate a novel multiplex assay for pan-cancer MSI detection using long mononucleotide repeat (LMR) markers.
  • To improve sensitivity and accuracy in identifying MSI across diverse tumor types.
  • To establish a reliable tool for both hereditary cancer identification and immunotherapy prediction.

Main Methods:

  • Development of a new multiplex assay employing novel LMR markers for MSI analysis.
  • Testing of 469 tumor samples from 20 cancer types, including 319 Lynch syndrome cases.
  • Validation against immunohistochemistry for deficient mismatch repair (dMMR) and comparison with the Promega pentaplex MSI panel.

Main Results:

  • The LMR assay demonstrated high sensitivity: 99% for colorectal cancer (CRC) and 96% for non-CRC in detecting dMMR status.
  • Excellent agreement with the Promega panel: 99% for CRC and 89% for non-CRC tumors.
  • Increased number of unstable markers and larger size shifts in dMMR tumors enhanced confidence in MSI determination.

Conclusions:

  • The LMR MSI Analysis System offers a sensitive and accurate method for pan-cancer MSI detection.
  • This assay expands the utility of MSI as a biomarker across a wider spectrum of cancers.
  • The system provides reliable results for identifying Lynch syndrome and predicting immunotherapy efficacy.