Fully automated real-time PCR for EGFR testing in non-small cell lung carcinoma.

Colling, Richard, Bancroft, Hollie, Langman, Gerald and Soilleux, Elizabeth (2019) Fully automated real-time PCR for EGFR testing in non-small cell lung carcinoma. Virchows Archiv : an international journal of pathology, 474 (2). pp. 187-192. ISSN 1432-2307.

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Official URL: https://link.springer.com/journal/428/474/2


Molecular 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.

Item Type: Article
Subjects: QW Microbiology. Immunology
QZ Pathology. Oncology
Divisions: Clinical Support > Pathology
Planned IP Care > Oncology and Clinical Haematology
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Depositing User: Beth Connors
Date Deposited: 22 Mar 2019 16:25
Last Modified: 22 Mar 2019 16:25
URI: http://www.repository.uhblibrary.co.uk/id/eprint/1965

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