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dc.contributor.authorColling, Richard
dc.contributor.authorBancroft, Hollie
dc.contributor.authorLangman, Gerald
dc.contributor.authorSoilleux, Elizabeth
dc.date.accessioned2018-12-19T00:30:16Z
dc.date.available2018-12-19T00:30:16Z
dc.date.issued2019-02
dc.identifier.issn0945-6317
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/287149
dc.description.abstractMolecular testing for mutations in the EGFR gene is commonplace for patients with non-small cell lung cancer (NSCLC). These patients are often very sick and management decisions need to be made urgently. In many cases, the results of molecular testing are needed the same day, in order to start targeted therapy and allow maximum benefit for patients. The Idylla™ EGFR Mutation Test offers rapid results within three hours of requesting. This study aimed to assess the concordance of Idylla™ EGFR Mutation Test results with current standard tests. Forty formalin-fixed, paraffin-embedded NSCLC tumour cases (20 EGFR mutant and EGFR 20 wild type) were analysed by the Idylla™ EGFR Mutation Test (CE-IVD) and compared with PCR and NGS methodologies. The overall concordance between Idylla™ and standard testing was 92.5% (95% CI 80.14% to 97.42%) and the specificity of Idylla™ was 100% (95% CI 83.89% to 100%). The sensitivity was affected by loss of tumour content in tissue blocks in a small number of NGS cases; however, comparing Idylla™ with PCR alone, there was 100% concordance (95% CI 89.85% to 100%). The Idylla™ EGFR Mutation Test shows comparative accuracy to routine PCR testing for the most common EGFR mutations in NSCLC. The Idylla™ also offers significantly reduced turn-around times compared with existing modalities and therefore the platform would be a useful addition to many molecular diagnostics units.
dc.format.mediumPrint-Electronic
dc.languageeng
dc.publisherSpringer Science and Business Media LLC
dc.rightsAttribution 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectHumans
dc.subjectCarcinoma, Non-Small-Cell Lung
dc.subjectLung Neoplasms
dc.subjectSensitivity and Specificity
dc.subjectDNA Mutational Analysis
dc.subjectMutation
dc.subjectGenes, erbB-1
dc.subjectAutomation
dc.subjectGenetic Testing
dc.subjectReal-Time Polymerase Chain Reaction
dc.subjectErbB Receptors
dc.titleFully automated real-time PCR for EGFR testing in non-small cell lung carcinoma.
dc.typeArticle
prism.endingPage192
prism.issueIdentifier2
prism.publicationDate2019
prism.publicationNameVirchows Arch
prism.startingPage187
prism.volume474
dc.identifier.doi10.17863/CAM.34458
dcterms.dateAccepted2018-11-13
rioxxterms.versionofrecord10.1007/s00428-018-2486-y
rioxxterms.versionVoR
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2019-02
dc.contributor.orcidColling, Richard [0000-0001-6344-9081]
dc.contributor.orcidSoilleux, Elizabeth [0000-0002-4032-7249]
dc.identifier.eissn1432-2307
dc.publisher.urlhttps://doi.org/10.1007/s00428-018-2486-y
rioxxterms.typeJournal Article/Review
cam.issuedOnline2018-11-23


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Attribution 4.0 International
Except where otherwise noted, this item's licence is described as Attribution 4.0 International