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Related Experiment Video

Updated: Mar 1, 2026

Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids
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EGFR T790M mutation testing within the osimertinib AURA Phase I study.

Simon Dearden1, Helen Brown1, Suzanne Jenkins2

  • 1Personalised Healthcare & Biomarkers, AstraZeneca, Cambridge, UK.

Lung Cancer (Amsterdam, Netherlands)
|June 5, 2017
PubMed
Summary

Accurate epidermal growth factor receptor (EGFR) mutation testing is crucial for non-small cell lung cancer (NSCLC) patients. This study found high concordance between local and central testing methods for EGFR mutations, including T790M, supporting the cobas® EGFR Mutation Test.

Keywords:
EGFR genesNon-small cell lung cancerOsimertinibProtein kinase inhibitors

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Area of Science:

  • Oncology
  • Molecular Diagnostics
  • Genetics

Background:

  • Accurate epidermal growth factor receptor (EGFR) mutation testing is essential for identifying patients with advanced non-small cell lung cancer (NSCLC) eligible for targeted therapies like osimertinib.
  • The T790M mutation confers resistance to earlier EGFR tyrosine kinase inhibitors (TKIs) and is a key target for newer agents.
  • There is a lack of consensus on the optimal method for detecting EGFR T790M mutations.

Purpose of the Study:

  • To evaluate the concordance between local and central testing methods for EGFR mutations, specifically sensitizing mutations and the T790M resistance mutation.
  • To assess the reliability of the cobas® EGFR Mutation Test for identifying patients suitable for osimertinib treatment.

Main Methods:

  • Tumor samples from patients screened for the osimertinib AURA Phase I/II study were analyzed.
  • Central testing was performed using the cobas® EGFR Mutation Test.
  • Results were compared against local laboratory results obtained through various methods, including Sanger sequencing, therascreen®, PNAClamp™, and Sequenom MassARRAY®.

Main Results:

  • Central laboratory testing demonstrated high success rates (99%) across three facilities.
  • High concordance was observed between central and local testing for common EGFR sensitizing mutations (>98%) and the T790M resistance mutation (>90%).
  • Tumor heterogeneity and technical factors may have influenced the observed concordance rates.

Conclusions:

  • EGFR mutation testing using the cobas® EGFR Mutation Test in centralized laboratories is feasible and successful.
  • Strong concordance between local and central testing, including for T790M, supports its use in clinical practice.
  • The cobas® EGFR Mutation Test has been approved as a companion diagnostic for osimertinib in the USA and Japan.