Deans, Z. C., Bilbe, N., O'Sullivan, B., Lazarou, L. P., de Castro, D. G., Parry, S., Dodson, A., Taniere, P., Clark, C., Butler, R. (2013) Improvement in the quality of molecular analysis of EGFR in non-small-cell lung cancer detected by three rounds of external quality assessment. JOURNAL OF CLINICAL PATHOLOGY, 66 (4). pp. 319-325. ISSN 0021-9746

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Abstract

Background The clinical need to determine the presence of epidermal growth factor receptor (EGFR) gene mutations in non-small-cell lung cancers (NSCLC) in order to make informed decisions for patient treatment has seen the widespread introduction of EGFR molecular testing in many laboratories. To ensure high-quality molecular testing and allow laboratories to externally measure the standard of the service, an external quality assessment (EQA) scheme was provided to assess the whole testing process. Methods Formalin-fixed paraffin-embedded NSCLC tumour sections were distributed to laboratories for routine EGFR molecular testing, and the genotyping accuracy, interpretation of the result and clerical accuracy of the report were independently assessed. Results Three rounds of assessment have identified many genotyping errors and have highlighted the need for external assessment and education in many testing laboratories. The main issues raised were the importance of accurate genotyping, including the use of common mutation nomenclature, clear unambiguous interpretation of the result, the impact of tumour sample assessment regarding amount of tumour being analysed and the heterogeneity of the sample on the molecular test result. Conclusions Improvements in all these areas were observed during the progression of the three EQA rounds, however, continuous unacceptably high genotyping error rates demonstrate the clear need for continual external assessment and education in this field.

Item Type:	Article
All Authors:	Deans, Z. C., Bilbe, N., O'Sullivan, B., Lazarou, L. P., de Castro, D. G., Parry, S., Dodson, A., Taniere, P., Clark, C., Butler, R.
Additional Information:	ISI Document Delivery No.: 107AV Times Cited: 0 Cited Reference Count: 15 Deans, Zandra C. Bilbe, Neil O'Sullivan, Brendan Lazarou, Lazarus P. de Castro, David Gonzalez Parry, Suzanne Dodson, Andrew Taniere, Philippe Clark, Caroline Butler, Rachel UK Clinical Pathology Accreditation Trust [0161]; Astra Zeneca; Qiagen; Roche; UK NEQAS for Molecular Pathology Specialist Advisory Group The 2010 run of the UK NEQAS EGFR EQA scheme was supported by a grant from the UK Clinical Pathology Accreditation Trust (0161). All other EQA runs were self-funded by participant laboratories. No funding parties had any input into scheme design, assessment or access to any specific participant data.ZCD has received educational grants from Astra Zeneca, Qiagen and Roche. ZCD, RB and DGC have consulted for Astra Zeneca and Roche. AD has consulted for Roche.We thank all the laboratories for their participation in the UK NEQAS scheme for EGFR testing in NSCLC, and the UK NEQAS for Molecular Pathology Specialist Advisory Group for their support and guidance. We thank the scheme assessors for all their work, and we also thank the Department of Cellular Pathology, Queen Elizabeth Hospital, Birmingham, and the All Wales Molecular Genetics Laboratory, University Hospital of Wales, Cardiff, for help with sample preparation and validation. Bmj publishing group London
Uncontrolled Keywords:	mutations gefitinib scheme therapy tumors
Research teams:	Clinical Units > Haemato-Oncology Unit
Depositing User:	Barry Jenkins
Date Deposited:	11 Apr 2013 09:09
Last Modified:	11 Apr 2013 09:09
URI:	http://publications.icr.ac.uk/id/eprint/12385

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