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Performance evaluation of a fully closed real-time PCR platform for the detection of KRAS p.G12C mutations in liquid biopsy of patients with non-small cell lung cancer
  1. Gianluca Gragnano,
  2. Mariantonia Nacchio,
  3. Roberta Sgariglia,
  4. Floriana Conticelli,
  5. Antonino Iaccarino,
  6. Caterina De Luca,
  7. Giancarlo Troncone,
  8. Umberto Malapelle
  1. Public Health, University of Naples Federico II, Naples, Italy
  1. Correspondence to Professor Giancarlo Troncone, Public Health, University of Naples Federico II, Naples 80131, Italy; giancarlo.troncone{at}


Whenever tissue sample is not available, non-small cell lung cancer (NSCLC) biomarker testing is performed with liquid biopsy. The Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation is a novel target in patients with NSCLC. In this study, 33 NSCLC frozen plasma samples, previously characterised for KRAS mutational status by next generation sequencing (NGS), were processed by the fully automated Idylla KRAS assay. In 30/33 cases, archival matched cell-free DNA (cfDNA) was also directly pipetted in the cartridge. Overall, 30/33 plasma and 28/30 cfDNA samples yielded valid results. In 29/30 of KRAS p.G12C mutant plasma samples and 26/28 of cfDNA, Idylla confirmed the NGS results. In conclusion, the Idylla NSCLC KRAS liquid biopsy assay may represent a reliable tool to assess KRAS p.G12C mutation.

  • molecular biology
  • lung neoplasms
  • pathology
  • molecular

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  • Handling editor Runjan Chetty.

  • Twitter @UmbertoMalapel1

  • Contributors UM, GT conceived the study; GG, MN, RS, FC, AI, CDL performed the experiments and collected the data; UM, GT wrote the original draft; all authors reviewed and approved the final version of the manuscript.

  • Funding This study was funded by Department of Public Health of the University of Naples Federico II. POR Campania FESR 2014–2020 Progetto 'Sviluppo di Approcci Terapeutici Innovativi per patologie Neoplastiche resistenti ai trattamenti - SATIN'.

  • Competing interests GT reports personal fees (as speaker bureau or advisor) from Roche, MSD, Pfizer and Bayer, unrelated to the current work. UM received personal fees (as consultant and/or speaker bureau) from Boehringer Ingelheim, Roche, MSD, Amgen, Thermo Fisher Scientifics, Diaceutics, GSK, Merck and AstraZeneca, unrelated to the current work. The other authors have no other conflicts of interest to declare.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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