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Region Hovedstaden - en del af Københavns Universitetshospital
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Multicenter Evaluation of the Fully Automated PCR-Based Idylla EGFR Mutation Assay on Formalin-Fixed, Paraffin-Embedded Tissue of Human Lung Cancer

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

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

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  3. Efficient Identification of miRNAs for Classification of Tumor Origin

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

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. The molecular profile of mucosal melanoma

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

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer 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
Vis graf over relationer

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.

OriginalsprogEngelsk
TidsskriftThe Journal of molecular diagnostics : JMD
Vol/bind21
Udgave nummer6
Sider (fra-til)1010-1024
Antal sider15
ISSN1525-1578
DOI
StatusUdgivet - nov. 2019

Bibliografisk note

Copyright © 2019 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

ID: 59041608