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

Solene 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

doi:10.1016/j.jmoldx.2019.06.010

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

Solene 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. RoemenNicol Trincheri, Sandra N. Freiberger, Markus Rechsteiner

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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 (

Original language	English
Pages (from-to)	1010-1024
Number of pages	15
Journal	Journal of Molecular Diagnostics
Volume	21
Issue number	6
DOIs	https://doi.org/10.1016/j.jmoldx.2019.06.010
Publication status	Published - Nov 2019

Keywords

TYROSINE KINASE INHIBITORS
GROWTH-FACTOR RECEPTOR
MOLECULAR BIOMARKERS
DIAGNOSIS
ASSOCIATION
PATHOLOGY

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10.1016/j.jmoldx.2019.06.010Licence: CC BY-NC-ND

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Evrard, S. M., Taranchon-Clermont, E., Rouquette, I., Murray, S., Dintner, S., Nam-Apostolopoulos, Y.-C., Bellosillo, B., Varela-Rodriguez, M., Nadal, E., Wiedorn, K. H., Melchior, L., Andrew, E., Jones, M., Ridgway, J., Frykman, C., Lind, L., Rot, M., Kern, I., Speel, E. J. M., ... Rechsteiner, M. (2019). Multicenter Evaluation of the Fully Automated PCR-Based Idylla EGFR Mutation Assay on Formalin-Fixed, Paraffin-Embedded Tissue of Human Lung Cancer. Journal of Molecular Diagnostics, 21(6), 1010-1024. https://doi.org/10.1016/j.jmoldx.2019.06.010

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

abstract = "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 (",

keywords = "TYROSINE KINASE INHIBITORS, GROWTH-FACTOR RECEPTOR, MOLECULAR BIOMARKERS, DIAGNOSIS, ASSOCIATION, PATHOLOGY",

author = "Evrard, {Solene M.} and Estelle Taranchon-Clermont and Isabelle Rouquette and Samuel Murray and Sebastian Dintner and Yun-Chung Nam-Apostolopoulos and Beatriz Bellosillo and Mar Varela-Rodriguez and Ernest Nadal and Wiedorn, {Klaus H.} and Linea Melchior and Emma Andrew and Mary Jones and Jennifer Ridgway and Christina Frykman and Linda Lind and Mitja Rot and Izidor Kern and Speel, {Ernst J. M.} and Roemen, {Guido M. J. M.} and Nicol Trincheri and Freiberger, {Sandra N.} and Markus Rechsteiner",

note = "Funding Information: Supported by Departament de Salut de la Generalitat de Catalunya–PERIS (Health Research and Innovation Strategic Plan) Program SLT006/17/00127 (E.N.) and the Department of Pathology of Copenhagen (L.M.).Disclosures: I.R. has worked as consultant and participated in advisory boards from Astra-Zeneca, BMS, Boehringer, MSD, Roche, and Takeda; B.B. has patent royalties from Biocartis and honoraria for speaker consultancy or advisory role from Astra-Zeneca, Biocartis, Merck-Serono, Novartis, Qiagen, Hoffman-La Roche, and ThermoFisher; E.J.M.S. has received a research grant from AstraZeneca. Funding Information: Supported by Departament de Salut de la Generalitat de Catalunya –PERIS (Health Research and Innovation Strategic Plan) Program SLT006/17/00127 (E.N.) and the Department of Pathology of Copenhagen (L.M.). Publisher Copyright: {\textcopyright} 2019 American Society for Investigative Pathology and the Association for Molecular Pathology",

year = "2019",

month = nov,

doi = "10.1016/j.jmoldx.2019.06.010",

language = "English",

volume = "21",

pages = "1010--1024",

journal = "Journal of Molecular Diagnostics",

issn = "1525-1578",

publisher = "Elsevier Science",

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}

Evrard, SM, Taranchon-Clermont, E, Rouquette, I, Murray, S, Dintner, S, Nam-Apostolopoulos, Y-C, Bellosillo, B, Varela-Rodriguez, M, Nadal, E, Wiedorn, KH, Melchior, L, Andrew, E, Jones, M, Ridgway, J, Frykman, C, Lind, L, Rot, M, Kern, I, Speel, EJM , Roemen, GMJM, Trincheri, N, Freiberger, SN & Rechsteiner, M 2019, 'Multicenter Evaluation of the Fully Automated PCR-Based Idylla EGFR Mutation Assay on Formalin-Fixed, Paraffin-Embedded Tissue of Human Lung Cancer', Journal of Molecular Diagnostics, vol. 21, no. 6, pp. 1010-1024. https://doi.org/10.1016/j.jmoldx.2019.06.010

Multicenter Evaluation of the Fully Automated PCR-Based Idylla EGFR Mutation Assay on Formalin-Fixed, Paraffin-Embedded Tissue of Human Lung Cancer. / Evrard, Solene M.; Taranchon-Clermont, Estelle; Rouquette, Isabelle et al.
In: Journal of Molecular Diagnostics, Vol. 21, No. 6, 11.2019, p. 1010-1024.

Research output: Contribution to journal › Article › Academic › peer-review

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T1 - Multicenter Evaluation of the Fully Automated PCR-Based Idylla EGFR Mutation Assay on Formalin-Fixed, Paraffin-Embedded Tissue of Human Lung Cancer

AU - Evrard, Solene M.

AU - Taranchon-Clermont, Estelle

AU - Rouquette, Isabelle

AU - Murray, Samuel

AU - Dintner, Sebastian

AU - Nam-Apostolopoulos, Yun-Chung

AU - Bellosillo, Beatriz

AU - Varela-Rodriguez, Mar

AU - Nadal, Ernest

AU - Wiedorn, Klaus H.

AU - Melchior, Linea

AU - Andrew, Emma

AU - Jones, Mary

AU - Ridgway, Jennifer

AU - Frykman, Christina

AU - Lind, Linda

AU - Rot, Mitja

AU - Kern, Izidor

AU - Speel, Ernst J. M.

AU - Roemen, Guido M. J. M.

AU - Trincheri, Nicol

AU - Freiberger, Sandra N.

AU - Rechsteiner, Markus

N1 - Funding Information: Supported by Departament de Salut de la Generalitat de Catalunya–PERIS (Health Research and Innovation Strategic Plan) Program SLT006/17/00127 (E.N.) and the Department of Pathology of Copenhagen (L.M.).Disclosures: I.R. has worked as consultant and participated in advisory boards from Astra-Zeneca, BMS, Boehringer, MSD, Roche, and Takeda; B.B. has patent royalties from Biocartis and honoraria for speaker consultancy or advisory role from Astra-Zeneca, Biocartis, Merck-Serono, Novartis, Qiagen, Hoffman-La Roche, and ThermoFisher; E.J.M.S. has received a research grant from AstraZeneca. Funding Information: Supported by Departament de Salut de la Generalitat de Catalunya –PERIS (Health Research and Innovation Strategic Plan) Program SLT006/17/00127 (E.N.) and the Department of Pathology of Copenhagen (L.M.). Publisher Copyright: © 2019 American Society for Investigative Pathology and the Association for Molecular Pathology

PY - 2019/11

Y1 - 2019/11

N2 - 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 (

AB - 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 (

KW - TYROSINE KINASE INHIBITORS

KW - GROWTH-FACTOR RECEPTOR

KW - MOLECULAR BIOMARKERS

KW - DIAGNOSIS

KW - ASSOCIATION

KW - PATHOLOGY

U2 - 10.1016/j.jmoldx.2019.06.010

DO - 10.1016/j.jmoldx.2019.06.010

M3 - Article

C2 - 31445213

SN - 1525-1578

VL - 21

SP - 1010

EP - 1024

JO - Journal of Molecular Diagnostics

JF - Journal of Molecular Diagnostics

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ER -