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Naslov:Multicenter evaluation of the fully automated PCR-based Idylla EGFR Mutation Assay on formalin-fixed, paraffin-embedded Q1 tissue of human lung cancer
Avtorji:Evrard, Solène M. (Avtor)
Clermont, Estelle T. (Avtor)
Rouquette, Isabelle (Avtor)
Murray, Samuel (Avtor)
Dintner, Sebastian (Avtor)
Nam-Apostolopoulos, Yun-Chung (Avtor)
Bellosillo, Beatriz (Avtor)
Rodriguez, Mar V. (Avtor)
Nadal, Ernest (Avtor)
Wiedorn, Klaus H. (Avtor)
Rot, Mitja (Avtor)
Kern, Izidor (Avtor)
Jezik:Angleški jezik
Tipologija:1.01 - Izvirni znanstveni članek
Organizacija:Logo UKPBAG - Univerzitetna klinika za pljučne bolezni in alergijo Golnik
Povzetek:Before initiating treatment of advanced nonesmall-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 nonesmall-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.
Ključne besede:non-small cell lung carconima -- diagnosis -- genetics, ErbB receptors, sequence analysis, tyrosine kinase inhibitors, epidermal growth factor receptor
Leto izida:2019
Založnik:Elsevier
Izvor:ZDA
UDK:616-006
ISSN pri članku:1943-7811
OceCobissID:3615508 Povezava se odpre v novem oknu
COBISS_ID:2048546161 Povezava se odpre v novem oknu
DOI:10.1016/j.jmoldx.2019.06.010 Povezava se odpre v novem oknu
Opombe:Soavtorja iz Slovenije: Mitja Rot, Izidor Kern; Nasl. z nasl. zaslona; Opis vira z dne 7. 10. 2019;
Število ogledov:814
Število prenosov:476
Datoteke:.pdf PDF - Predstavitvena datoteka, prenos (714,24 KB)
.xlsx XLSX - Priloga, prenos (39,72 KB)
URL URL - Izvorni URL, za dostop obiščite https://jmd.amjpathol.org/article/S1525-1578(19)30355-1/pdf
 
Nadgradivo:J. mol. diagn.
American Society for Investigative Pathology and the Association for Molecular Pathology
 
Metapodatki:XML RDF-CHPDL DC-XML DC-RDF
Avtorske pravice:2019 American Society for Investigative Pathology and the Association for Molecular Pathology
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Licence

Licenca:CC BY-NC-ND 4.0, Creative Commons Priznanje avtorstva-Nekomercialno-Brez predelav 4.0 Mednarodna
Povezava:http://creativecommons.org/licenses/by-nc-nd/4.0/deed.sl
Opis:Najbolj omejujoča licenca Creative Commons. Uporabniki lahko prenesejo in delijo delo v nekomercialne namene in ga ne smejo uporabiti za nobene druge namene.
Začetek licenciranja:13.06.2019

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