BACKGROUND: Testing for epidermal growth factor receptor (EGFR) mutations is an essential recommendation in guidelines for metastatic non-squamous non-small-cell lung cancer, and is considered mandatory in European countries. However, in practice, challenges are often faced when carrying out routine biomarker testing, including access to testing, inadequate tissue samples and long turnaround times (TATs). MATERIALS AND METHODS: To evaluate the real-world EGFR testing practices of European pathology laboratories, an online survey was set up and validated by the Pulmonary Pathology Working Group of the European Society of Pathology and distributed to 64 expert testing laboratories. The retrospective survey focussed on laboratory organisation and daily EGFR testing practice of pathologists and molecular biologists between 2018 and 2021. RESULTS: TATs varied greatly both between and within countries. These discrepancies may be partly due to reflex testing practices, as 20.8% of laboratories carried out EGFR testing only at the request of the clinician. Many laboratories across Europe still favour single-test sequencing as a primary method of EGFR mutation identification; 32.7% indicated that they only used targeted techniques and 45.1% used single-gene testing followed by next-generation sequencing (NGS), depending on the case. Reported testing rates were consistent over time with no significant decrease in the number of EGFR tests carried out in 2020, despite the increased pressure faced by testing facilities during the COVID-19 pandemic. ISO 15189 accreditation was reported by 42.0% of molecular biology laboratories for single-test sequencing, and by 42.3% for NGS. 92.5% of laboratories indicated they regularly participate in an external quality assessment scheme. CONCLUSIONS: These results highlight the strong heterogeneity of EGFR testing that still occurs within thoracic pathology and molecular biology laboratories across Europe. Even among expert testing facilities there is variability in testing capabilities, TAT, reflex testing practice and laboratory accreditation, stressing the need to harmonise reimbursement technologies and decision-making algorithms in Europe.

Biomedical Research Centre Navarra Health Service Pamplona Navarra Spain

Cell Biology and Biotherapy Unit INT Fondazione Pascale Via M Semmola Naples Italy

Department of Biopathology Centre Léon Bérard Lyon France

Department of Biopathology Centre Leon Berard Unicancer and Pathology Research Platform Cancer Research Center of Lyon Lyon France

Department of Biopathology CHRU ICL CHRU Nancy Vandoeuvre lès Nancy France

Department of Biopathology Institut de Cancérologie de Lorraine University of Lorraine Vandoeuvre Les Nancy France

Department of Biopathology Jean Perrin Centre Clermont Ferrand France

Department of Cardiac Thoracic Vascular Sciences and Public Health University of Padova Padova Italy

Department of Diagnostics and Public Health Section of Pathology University and Hospital Trust of Verona Verona Italy

Department of Genetics University Hospital Bichat Claude Bernard Paris University Paris France

Department of Histopathology St Vincent's University Hospital University College Dublin School of Medicine Dublin Ireland

Department of Innate Immunity and Immunotherapy Institut de Cancérologie de l'Ouest Centre Paul Papin Angers France

Department of Molecular Cancer Genetics Laboratory of Biochemistry and Molecular Biology University Hospital of Strasbourg Strasbourg France

Department of Oncology and Hemato Oncology University of Milan Milan Italy

Department of Oncology University of Turin San Luigi Hospital Orbassano Turin Italy

Department of Pathological Anatomy and Cytology CHRU de Brest Brest France; LBAI UMR1227 INSERM University of Brest CHU de Brest Brest France

Department of Pathology 12 de Octubre University Hospital Universidad Complutense de Madrid Research Institute 12 de Octubre University Hospital CIBERONC Madrid Spain

Department of Pathology Amsterdam University Medical Center VUMC University of Amsterdam Amsterdam Netherlands

Department of Pathology and Molecular Medicine Thomayer University Hospital Prague Czech Republic

Department of Pathology CHRU Tours Hôpital Trousseau Chambray lès Tours France

Department of Pathology CHU de Caen Côte de Nacre Caen France

Department of Pathology Clermont Auvergne University Molecular Imaging and Theranostic Strategies Center Jean Perrin Montalembert Clermont Ferrand France

Department of Pathology Complejo Hospitalario de Navarra Pamplona Navarra Spain

Department of Pathology Erasme Hospital HUB ULB Brussels Belgium

Department of Pathology Erasme Hospital HUB ULB Brussels Belgium; CurePath Jumet Belgium

Department of Pathology Gregorio Marañón General University Hospital Madrid Spain

Department of Pathology Groupe Hospitalier Paris Saint Joseph Paris France

Department of Pathology Groupement Hospitalier Est Bron France

Department of Pathology Gui de Chauliac Hospital Montpellier University Medical Center University of Montpellier 80 Avenue Augustin Fliche Montpellier France

Department of Pathology Hôpital Cochin Assistance Publique Hôpitaux de Paris Université de Paris Paris France

Department of Pathology Hospital Bichat Bichat Assistance Publique Hôpitaux de Paris; Université Paris Cité Paris France

Department of Pathology Institut Mutualiste Montsouris Paris France

Department of Pathology Institute for Advanced Biosciences CHU Grenoble Alpes Université Grenoble Alpes Grenoble France

Department of Pathology Institute of Medical Genetics and Pathology University Hospital Basel University of Basel Basel Switzerland

Department of Pathology IUC T Oncopole Toulouse France

Department of Pathology Rouen University Hospital France and Normandie University UNIROUEN Inserm U1245 Rouen France

Department of Pathology St Olav's Hospital Trondheim University Hospital Trondheim Norway

Department of Pathology Turku University Hospital Turku Finland

Department of Pathology Université d'Angers Centre Hospitalier Universitaire d'Angers Angers France

Department of Pathology University Clinic Golnik Golnik Slovenia

Department of Pathology University Hospital Antwerp and University of Antwerp Antwerp Belgium

Department of Pathology University Hospital of Bordeaux Hôpital Haut Lévêque Pessac France

Department of Pathology University Hospital of Saint Etienne Saint Etienne France

Department of Pathology University Hospital of Strasbourg 67098 Strasbourg France

Department of Pathology University Medical Center Groningen University of Groningen Groningen Netherlands

Department of Pathology University of Oradea Oradea Romania

Department of Public Health University of Naples Federico 2 Naples Italy

Department of Thoracic Pathology Section of Pathology University Clinical Centre of Serbia Belgrade Serbia

Department of Tumor Biology University Hospital of Bordeaux Hospital Haut Lévêque Pessac France

Diagnostic and Research Institute of Pathology Medical University of Graz Graz Austria

Division for Pulmonary Cytology Department of Pathology and Cytology University Hospital Centre Zagreb School of Medicine University of Zagreb Zagreb Croatia

Division of Medical Oncology 2 Veneto Institute of Oncology IOV IRCCS Padova Italy

Division of Pathology University Hospital Città Della Salute Turin Italy

HUSLAB Department of Pathology Helsinki University Hospital Helsinki Finland

IAP PM Institute of Anatomical and Molecular Pathology Faculty of Medicine University of Coimbra 3004 504 Coimbra Portugal

Institute for Pathology Medical Faculty Belgrade Serbia

Institute of Molecular and Clinical Pathology and Medical Genetics Faculty of Medicine University Hospital Ostrava Ostrava Czech Republic

Institute of Pathology and Molecular Pathology Bundeswehrkrankenhaus Ulm Oberer Eselsberg 40 89081 Ulm Germany

Institute of Pathology Cantonal Hospital Baselland Liestal Switzerland

Institute of Pathology Department of Laboratory Medicine and Pathology Lausanne University Hospital and University of Lausanne Lausanne Switzerland

Institute of Pathology Heidelberg University Hospital Heidelberg Germany; Translational Lung Research Center Heidelberg Heidelberg Germany

Inter Hospital Pathology Division Istituto di Ricovero e Cura a Carattere Scientifico MultiMedica Milan Italy

Laboratory for Molecular Pathology Department of Pathology University of Zagreb School of Medicine and University Hospital Centre Zagreb Zagreb Croatia

Laboratory of Clinical and Experimental Pathology FHU OncoAge Biobank Côte d'Azur BB 0033 00025 Louis Pasteur Hospital IRCAN Université Côte d'Azur Nice France

Medical Unit of Molecular Genetic Grenoble University Hospital Grenoble France

Multidisciplinary Clinical Center Kommunarka of the Moscow Health Department Moscow Russia

Oncogenomics Unit European Institute of Oncology Milan Italy

Pathology Unit San Luigi Hospital Orbassano Turin Italy

Pharmacogenomics and Molecular Oncology Unit Biochemistry Department Assistance Publique Hopitaux de Paris Hôpital Européen Georges Pompidou Paris France

Solid Tumour Laboratory Pathology and Oncobiology Department CHU Montpellier University of Montpellier Montpellier France

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Future perspective for the application of predictive biomarker testing in advanced stage non-small cell lung cancer

Developments in predictive biomarker testing and targeted therapy in advanced stage non-small cell lung cancer and their application across European countries