ArticlePloS one2014
The relevance of external quality assessment for molecular testing for ALK positive non-small cell lung cancer: results from two pilot rounds show room for optimization.
Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed, 30 citations in OpenAlex.
- Article
- A novel break site of EML4-ALK report and a rare PRKAR1A-ALK report analyzed by different ALK detection platforms in non-small cell lung cancer patients.Thoracic cancer · 2021Article
- Frequency of Participation in External Quality Assessment Programs Focused on Rare Diseases: Belgian Guidelines for Human Genetics Centers.JMIR medical informatics · 2021Article
- Cost-Effectiveness of Lorlatinib as a First-Line Therapy for Untreated Advanced Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer.Frontiers in oncology · 2021Article
- Lung cancer biomarker testing: perspective from Europe.Translational lung cancer research · 2020Review
- Performance of Oncomine Fusion Transcript kit for formalin-fixed, paraffin-embedded lung cancer specimens.Cancer science · 2019Article
- Ceritinib for Untreated Anaplastic Lymphoma Kinase-Positive Advanced Non-Small-Cell Lung Cancer: An Evidence Review Group Evaluation of a NICE Single Technology Appraisal.PharmacoEconomics · 2019Review
- Simultaneous detection of lung fusions using a multiplex RT-PCR next generation sequencing-based approach: a multi-institutional research study.BMC cancer · 2018Article
- Accreditation, setting and experience as indicators to assure quality in oncology biomarker testing laboratories.British journal of cancer · 2018Article
- A stitch in time saves nine: external quality assessment rounds demonstrate improved quality of biomarker analysis in lung cancer.Oncotarget · 2018Article
- ALK-rearrangement in non-small-cell lung cancer (NSCLC).Thoracic cancer · 2018Review
- Review
- The ins and outs of molecular pathology reporting.Virchows Archiv : an international journal of pathology · 2017Review
- Testing for ROS1 in non-small cell lung cancer: a review with recommendations.Virchows Archiv : an international journal of pathology · 2016Review
- Endorsing good quality assurance practices in molecular pathology: risks and recommendations for diagnostic laboratories and external quality assessment providers.Virchows Archiv : an international journal of pathology · 2016Review
Corrections and comments
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Authors and funding
10 authors at 7 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
background and purposeMolecular profiling should be performed on all advanced non-small cell lung cancer with non-squamous histology to allow treatment selection. Currently, this should include EGFR mutation testing and testing for ALK rearrangements. ROS1 is another emerging target. ALK rearrangement status is a critical biomarker to predict response to tyrosine kinase inhibitors such as crizotinib. To promote high quality testing in non-small cell lung cancer, the European Society of Pathology has introduced an external quality assessment scheme. This article summarizes the results of the first two pilot rounds organized in 2012-2013. MATERIALS AND
methodsTissue microarray slides consisting of cell-lines and resection specimens were distributed with the request for routine ALK testing using IHC or FISH. Participation in ALK FISH testing included the interpretation of four digital FISH images.
resultsData from 173 different laboratories was obtained. Results demonstrate decreased error rates in the second round for both ALK FISH and ALK IHC, although the error rates were still high and the need for external quality assessment in laboratories performing ALK testing is evident. Error rates obtained by FISH were lower than by IHC. The lowest error rates were observed for the interpretation of digital FISH images.
conclusionThere was a large variety in FISH enumeration practices. Based on the results from this study, recommendations for the methodology, analysis, interpretation and result reporting were issued. External quality assessment is a crucial element to improve the quality of molecular testing.
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