Article Text

Download PDFPDF
Idylla EGFR assay on extracted DNA: advantages, limits and place in molecular screening according to the latest guidelines for non-small-cell lung cancer (NSCLC) patients
  1. Emmanuel Khalifa1,
  2. Caroline Chapusot2,
  3. Benjamin Tournier2,
  4. Julie Sentis1,
  5. Estelle Marion1,
  6. Alicia Remond2,
  7. Manon Aubry2,
  8. Célia Pioche2,
  9. Anthony Bergeron3,
  10. Charlotte Primois1,
  11. Larry Blanchard1,
  12. Alice Millière3,
  13. Marlène Boucheix1,
  14. Yannick Léger1,
  15. Marine Bairrao1,
  16. Véronique Brouste4,
  17. Laurent Martin2,3,
  18. Isabelle Soubeyran1
  1. 1Biopathology, Institut Bergonié, Bordeaux, France
  2. 2Platform of Somatic Oncology of Burgundy, Centre Hospitalier Universitaire de Dijon, Dijon, France
  3. 3Department of Pathology, Centre Hospitalier Universitaire de Dijon, Dijon, France
  4. 4Research and Clinical Epidemiology Unit - Biostatistics, Institut Bergonié, Bordeaux, France
  1. Correspondence to Dr Emmanuel Khalifa, Biopathology, Institut Bergonié, Bordeaux 33000, France; e.khalifa{at}


Aims Idylla epidermal growth factor receptor (EGFR) is a fast and fully automated mutation assay that is easy to implement. However, under the Biocartis-recommended technical conditions, tissue sections are directly introduced into the cartridge, at the risk of exhausting the tumour sample. In this study, we evaluate the performance of Idylla EGFR on extracted DNA and discuss its place within the global non-small-cell lung cancer (NSCLC) screening strategy.

Methods 577 comparative tests between Idylla EGFR on extracted DNA and next-generation sequencing (NGS) were performed across two centres.

Results Preanalytical thresholds were established (20% tumour cell content, 50 ng DNA input) and challenged prospectively in routine practice. 16.8% of samples referred for screening were considered non eligible for Idylla EGFR testing. Due to discordant by design cases, Idylla EGFR sensitivity was 86.9% for currently actionable EGFR mutations. Idylla EGFR specificity was 100% in first-line screening. NGS was always feasible on the same DNA.

Conclusion Idylla EGFR on extracted DNA is feasible and enables tumour material to be saved compared with tissue section use. It is not necessary to replace the analytical thresholds of the Biocartis algorithm. Due to both the limits of the mutational repertoire and the high increase of targetable genes in NSCLC, the use of Idylla EGFR should be restricted to clinical emergency situations accompanied by NGS.

  • lung neoplasms
  • molecular biology
  • diagnostic screening programs
  • biomarkers, tumor
  • pathology, molecular

Data availability statement

All data relevant to the study are included in the article or uploaded as online supplemental information.

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Data availability statement

All data relevant to the study are included in the article or uploaded as online supplemental information.

View Full Text


  • Handling editor Runjan Chetty.

  • EK and CC contributed equally.

  • LM and IS contributed equally.

  • Contributors EK is the guarantor of this study. EK, IS, CC and LM conceived and designed the study. EK and IS wrote the manuscript and supervised the project. CC, LM and BT contributed to the manuscript. EK, IS, CC, BT, LM and VB performed data analysis and statistical analysis. JS, EM, AR, MA, CPr, AB, LB, AM, MBo, YL and MBa performed the experiments and collated the data. EK edited the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests EK has received honoraria from Biocartis. The remaining authors declare no conflict of interest.

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

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.