Do targeted NGS panels include NSCLC guideline-recommended biomarkers?

Area of Science:

• Oncology
• Molecular Diagnostics
• Genomics

Background:

• National Comprehensive Cancer Network (NCCN) guidelines recommend 12 molecular biomarkers for targeted therapy selection in metastatic non-small cell lung cancer (mNSCLC).
• Next-generation sequencing (NGS) panels are crucial for identifying these biomarkers, but variations in panel composition exist.
• This variability may affect the comprehensive assessment of biomarkers required for optimal mNSCLC treatment.

Purpose of the Study:

• To evaluate the inclusion of NCCN-recommended mNSCLC biomarkers in commercially available targeted NGS panels.
• To identify gaps in biomarker coverage across different NGS panel types.

Main Methods:

• A descriptive database review of targeted NGS panels (2-50 genes) was performed.
• Databases searched included DEX Diagnostics Exchange Registry and Concert Genetic Testing Unit Test Identifier.
• Panels were assessed for the presence of 12 NCCN-recommended biomarkers, including single-nucleotide variants, fusions, rearrangements, and copy number variants.

Main Results:

• Seventy-seven targeted NGS panels were analyzed.
• Most panels commonly included EGFR (91%), KRAS (87%), and BRAF (86%) single-nucleotide variants.
• Fewer than half of panels (41%) included fusions/rearrangements, and NTRK fusions were notably absent in many. MET amplification was rare (12%). Critically, only 5 (6%) panels captured all 12 recommended biomarkers.

Conclusions:

• A significant proportion of commercially available NGS panels for mNSCLC lack comprehensive coverage of all NCCN-recommended biomarkers.
• The limited inclusion of specific biomarkers like NTRK fusions and MET amplification highlights potential gaps in diagnostic capabilities.
• Ensuring targeted NGS panels include all relevant biomarkers is essential for accurate patient stratification and effective mNSCLC treatment.