NSCLC TMB test kits are NGS-based in vitro diagnostic devices used to quantify tumor mutational burden in non-small cell lung cancer tissue samples. TMB is calculated as mutations per megabase (mut/Mb) by sequencing a defined set of genes and counting somatic mutations. A TMB-High result (typically ≥10 mut/Mb) may indicate potential benefit from immune checkpoint inhibitor therapy. The test requires sequencing of hundreds of genes to accurately estimate TMB, though the output is a single numerical biomarker. Multiple commercial platforms offer TMB assessment, including FoundationOne CDx and MSK-IMPACT.