Accreditation, setting and experience as indicators to assure quality in oncology biomarker testing laboratories

British Journal of Cancer
V TackE M C Dequeker

Abstract

Predictive biomarkers allow clinicians to optimise cancer treatment decisions. Therefore, molecular biomarker test results need to be accurate and swiftly available. To ensure quality of oncology biomarker testing, external quality assessments (EQA) for somatic variant analyses were organised. This study hypothesised whether laboratory characteristics influence the performance of laboratories and whether these can be imposed before authorisation of biomarker testing. Longitudinal EQA data from the European Society of Pathology were available over six (metastatic colorectal cancer) and four years (non-small cell lung cancer), including the percentage of analysis errors and technical failures, and information on laboratory characteristics (accreditation status, laboratory setting, number of samples analysed and detection method). Statistical models for repeated measurements were used to analyse the association between the EQA results and the laboratory characteristics. Laboratory accreditation was associated with fewer analysis errors in early stages of biomarker introduction into the laboratory. Analysing more samples, or university and research laboratories showed better performance. Changing the detection method did not have a...Continue Reading

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Citations

Feb 6, 2019·Virchows Archiv : an International Journal of Pathology·Cleo KeppensElisabeth M C Dequeker
Dec 5, 2020·Virchows Archiv : an International Journal of Pathology·Cleo KeppensJan H von der Thüsen
Oct 5, 2020·The Journal of Molecular Diagnostics : JMD·Cleo KeppensElisabeth M C Dequeker
Jun 9, 2020·Journal of Cystic Fibrosis : Official Journal of the European Cystic Fibrosis Society·Nele LaudusElisabeth M C Dequeker
Nov 24, 2020·Virchows Archiv : an International Journal of Pathology·Cleo KeppensElisabeth M C Dequeker
Mar 25, 2020·The Journal of Molecular Diagnostics : JMD·Kaat Van CasterenUNKNOWN International Quality Network for Pathology ctDNA Working Group and the European Society of Pathology Foundation Assessors

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Methods Mentioned

BETA
genotyping

Software Mentioned

SAS

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