Clinical Concordance of Pan Lung Cancer PCR Panel Covering 167 Actionable Variants Across 11 Genes and Other Validated Assays in the LC-SCRUM-Asia Registry.

[INTRODUCTION] The increasing number of actionable alterations across multiple genes in NSCLC has led to the need for molecular testing. Next-generation sequencing is one solution, but the turnaround time and cost limit its use. We assessed the concordance of a Pan Lung Cancer PCR Panel covering 167 variants across 11 genes in NSCLC with validated assays.

[METHODS] A total of 568 NSCLC samples (168 with mutation, 63 with fusions, 60 with fusions, 49 with mutation, 50 with mutation, 44 with exon 14 skipping 47 with fusions, 50 with G12C, and 2 with fusions) and sufficient residual material were selected from archival samples in the LC-SCRUM-Asia registry. Samples were analyzed by an independent central laboratory blinded to other test results.

[RESULTS] The success rate for the polymerase chain reaction (PCR) panel was 100%. The overall percent agreement for the panel results for all genes was higher than 98.5%: mutation, 99.1% (97.4-99.8)/98.7% (96.2-99.7) (Oncomine Dx Target Test (ODxTT)/Cobas v2), fusions, 99.4% (97.9-99.9)/97.4% (92.6-99.5)/97.5% (92.9-99.5) (ODxTT/FISH/IHC), fusions 99.1% (97.5-99.8)/98.4% (94.4-99.8) (ODxTT/ROS1 PCR), fusions 98.5% (95.5-99.7) (Oncomine Comprehensive Assay 3.0); and (ODxTT), , and (Oncomine Comprehensive Assay 3.0), 100%.

[CONCLUSIONS] The Pan Lung Cancer PCR Panel was highly concordant with other assays. The panel can be performed in local laboratories with a rapid turnaround time and represents an attractive alternative to next-generation sequencing for patients with lung cancer.