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Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
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Novel Approach to Proficiency Testing Reveals Significant Variations in Biomarker Practice Leading to Critical

Kassandra R Bisson1,2, Andrea Beharry2, Normand Blais3

  • 1Canadian Pathology Quality Assurance - Assurance qualite canadienne en pathologie (CPQA-AQCP), Richmond, British Columbia, Canada.

JTO Clinical and Research Reports
|June 26, 2025
PubMed
Summary

External quality assurance for non-small cell lung cancer (NSCLC) biomarker testing revealed significant variations in accuracy and turnaround times among Canadian laboratories. This proficiency testing highlights the need for ongoing improvements to enhance patient outcomes.

Keywords:
BiomarkersNSCLCPrecision oncologyProficiency testing

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Area of Science:

  • Oncology
  • Pathology
  • Molecular Diagnostics

Background:

  • Timely and accurate biomarker testing is crucial for effective non-small cell lung cancer (NSCLC) treatment.
  • External Quality Assurance (EQA) programs are essential for maintaining laboratory standards.

Purpose of the Study:

  • To report the results of the first end-to-end molecular biomarker EQA challenge for NSCLC in Canada.
  • To assess the accuracy, turnaround time, and report interpretation of molecular testing in Canadian laboratories.

Main Methods:

  • Three NSCLC tissue specimens with clinical vignettes were distributed to participating laboratories.
  • Laboratories performed immunohistochemistry and gene sequencing, submitting timed reports for assessment.
  • Molecular pathologists and medical oncologists evaluated reports and recommended treatments.

Main Results:

  • Thirteen Canadian laboratories participated, with turnaround times ranging from 5 to 57 days (median 22.5).
  • Only 15% of laboratories reported results within 2 weeks; 31% took over 30 days.
  • 23% achieved optimal status, while 8% failed due to critical errors and 23% were suboptimal due to delays.

Conclusions:

  • This novel EQA approach revealed substantial differences in NSCLC biomarker testing quality across Canadian laboratories.
  • Improvements in turnaround times and reporting clarity, supported by regular external measurement, are needed.
  • Enhancing biomarker testing quality is vital for improving patient outcomes in NSCLC care.