Evaluation of a fast and fully automated platform to diagnose EGFR and KRAS mutations in formalin-fixed and paraffin-embedded non-small cell lung cancer samples in less than one day

Aims Searching for EGFR and KRAS mutations within non-small cell lung carcinoma (NSCLC) samples remains time-consuming and can delay treatment choices in patients with acute deterioration. We evaluated the performances of the fully automated Idylla platform to quickly detect these mutations in NSCLC samples. Methods We used the Idylla EGFR Mutation Assay and the Idylla KRAS Mutation Test to analyse 18 formalin fixed paraffin-embedded NSCLC tumour samples with known EGFR and KRAS mutation status according to next-generation sequencing (NGS) and droplet digital PCR (ddPCR) for EGFRT790M mutations. Results Idylla assays identified KRAS and EGFR activating mutations in 4 and 10 NSCLC samples, respectively. EGFRT790M resistance mutations were identified in only 1 sample using Idylla but in 4 and 14 samples using NGS and ddPCR, respectively. No false positive result was noted with Idylla assays. Mutation written report was obtained after 130 min (KRAS assays) to 140 min (EGFR assays). Conclusions The Idylla platform is an interesting ancillary first-line fast and fully automated tool to detect EGFR and KRAS mutations in NSCLC samples allowing rapid treatment choices in patients with acute deterioration.