Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

Multicenter Evaluation of the Fully Automated PCR-Based Idylla EGFR Mutation Assay on Formalin-Fixed, Paraffin-Embedded Tissue of Human Lung Cancer

Research output: Contribution to journalJournal articleResearchpeer-review

  1. Multicenter Evaluation of the Idylla NRAS-BRAF Mutation Test in Metastatic Colorectal Cancer

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Diagnostic potential of miR-126, miR-143, miR-145, and miR-652 in malignant pleural mesothelioma

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Efficient Identification of miRNAs for Classification of Tumor Origin

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Prevalence of Human Papillomavirus infection in unselected SurePath samples using the APTIMA HPV mRNA assay

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Molecular Characterization of the Danish Prion Diseases Cohort With Special Emphasis on Rare and Unique Cases

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. EP1.08-07 Correlation Between Genetic Profiling and Response in Danish ALK-Positive NSCLC Patients Treated with Crizotinib

    Research output: Contribution to conferencePosterResearchpeer-review

  3. A Novel Eight Octapeptide Repeat Insertion in PRNP Causing Prion Disease in a Danish Family

    Research output: Contribution to journalJournal articleResearchpeer-review

  • Solène M Evrard
  • Estelle Taranchon-Clermont
  • Isabelle Rouquette
  • Samuel Murray
  • Sebastian Dintner
  • Yun-Chung Nam-Apostolopoulos
  • Beatriz Bellosillo
  • Mar Varela-Rodriguez
  • Ernest Nadal
  • Klaus H Wiedorn
  • Linea Melchior
  • Emma Andrew
  • Mary Jones
  • Jennifer Ridgway
  • Christina Frykman
  • Linda Lind
  • Mitja Rot
  • Izidor Kern
  • Ernst J M Speel
  • Guido M J M Roemen
  • Nicol Trincheri
  • Sandra N Freiberger
  • Markus Rechsteiner
View graph of relations

Before initiating treatment of advanced non-small-cell lung cancer with tyrosine kinase inhibitors (eg, erlotinib, gefitinib, osimertinib, and afatinib), which inhibit the catalytic activity of epidermal growth factor receptor (EGFR), clinical guidelines require determining the EGFR mutational status for activating (EGFR exons 18, 19, 20, or 21) and resistance (EGFR exon 20) mutations. The EGFR resistance mutation T790M should be monitored at cancer progression. The Idylla EGFR Mutation Assay, performed on the Idylla molecular diagnostics platform, is a fully automated (<2.5 hours turnaround time) sample-to-result molecular test to qualitatively detect 51 EGFR oncogene point mutations, deletions, or insertions. In a 15-center evaluation, Idylla results on 449 archived formalin-fixed, paraffin-embedded tissue sections, originating from non-small-cell lung cancer biopsies and resection specimens, were compared with data obtained earlier with routine reference methods, including next-generation sequencing, Sanger sequencing, pyrosequencing, mass spectrometry, and PCR-based assays. When results were discordant, a third method of analysis was performed, when possible, to confirm test results. After confirmation testing and excluding invalids/errors and discordant results by design, a concordance of 97.6% was obtained between Idylla and routine test results. Even with <10 mm2 of tissue area, a valid Idylla result was obtained in 98.9% of the cases. The Idylla EGFR Mutation Assay enables sensitive detection of most relevant EGFR mutations in concordance with current guidelines, with minimal molecular expertise or infrastructure.

Original languageEnglish
JournalThe Journal of molecular diagnostics : JMD
Volume21
Issue number6
Pages (from-to)1010-1024
Number of pages15
ISSN1525-1578
DOIs
Publication statusPublished - Nov 2019

ID: 59041608