Do Targeted NGS Panels Include NSCLC Guideline-Recommended Biomarkers?

OBJECTIVES: National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology recommend the assessment of 12 molecular biomarkers to determine eligibility for targeted drug therapies in metastatic non-small cell lung cancer (mNSCLC). However, variation exists in the composition of next-generation sequencing (NGS) panels. This study evaluates the inclusion of recommended mNSCLC biomarkers in commercially available targeted NGS panels. STUDY DESIGN: A descriptive database review was conducted to characterize molecular testing panels. METHODS: Targeted panels were classified as 2 to 50 genes. The DEX Diagnostics Exchange Registry and the Concert Genetic Testing Unit Test Identifier database were searched for NGS-based lung and multicancer indications. Tests were excluded if their indication precluded usage in lung cancer, NGS technology was not used, or the panel was retired. Each panel was assessed for the inclusion of biomarkers from V.11.2024 NCCN guidelines: ALK, BRAF, EGFR, ERBB, KRAS, NTRK1/2/3, RET, ROS1, MET exon 14 skipping, and MET amplification. RESULTS: Seventy-seven targeted NGS panels were included. The mean number of biomarkers captured in lung-specific vs multicancer panels was similar (6.6 vs 6.4). Most biomarkers were single-nucleotide variants (82%), and the most common were EGFR (91%), KRAS (87%), and BRAF (86%). Fusions and rearrangements were represented in less than half (41%) of panels, and NTRK fusions were often absent, with NTRK1, NTRK2, and NTRK3 appearing in only 23%, 14%, and 19% of the included panels. The inclusion of copy number variant, specifically MET amplification, was rare (12%). Only 5 (6%) panels captured all 12 recommended biomarkers. CONCLUSIONS: Of 77 unique panels evaluated, only 5 captured all recommended biomarkers for mNSCLC. Ensuring targeted panels assess all relevant biomarkers is crucial for optimal patient treatment.