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

J Clin Pathol. 2017 Jun;70(6):544-549. doi: 10.1136/jclinpath-2016-204202. Epub 2017 Feb 2.

Abstract

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.

Keywords: EGFR; LUNG CANCER; MOLECULAR PATHOLOGY; PCR.

Publication types

  • Evaluation Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Carcinoma, Non-Small-Cell Lung / genetics*
  • DNA Mutational Analysis / instrumentation
  • ErbB Receptors / genetics*
  • Female
  • Humans
  • Lung Neoplasms / genetics*
  • Male
  • Middle Aged
  • Mutation / genetics*
  • Proto-Oncogene Proteins p21(ras) / genetics*

Substances

  • KRAS protein, human
  • ErbB Receptors
  • Proto-Oncogene Proteins p21(ras)