The diagnosis of Waldenström's macroglobulinemia (WM), an IgM-associated lymphoplasmacytic lymphoma, can be challenging due to the different forms of disease presentation. Furthermore, in recent years, WM has witnessed remarkable progress on the diagnostic front, as well as a deeper understanding of the disease biology, which has affected clinical practice. This, together with the increasing variety of tools and techniques available, makes it necessary to have a practical guidance for clinicians to perform the initial evaluation of patients with WM. In this paper, we present the consensus recommendations and laboratory requirements for the diagnosis of WM developed by the European Consortium of Waldenström's Macroglobulinemia (ECWM), for both clinical practice as well as the research/academical setting. We provide the procedures for multiparametric flow cytometry, fluorescence in situ hybridization and molecular tests, and with this offer guidance for a standardized diagnostic work-up and methodological workflow of patients with IgM monoclonal gammopathy of uncertain significance, asymptomatic and symptomatic WM.

ASST Grande Ospedale Metropolitano Niguarda Hospital Milan Italy

Canberra Health Services College of Medicine Biology and Environment Australian National University Canberra ACT Australia

Centre for Waldenströms Macroglobulinaemia and Related Conditions University College London Hospitals National Health Service Foundation Trust London UK

Clinical Research Development and Phase 1 Unit ASST Spedali Civili di Brescia Brescia Italy

Département d'Hématologie Hôpital Pitié Salpêtrière APHP UPMC Université Paris Paris France

Department of Clinical Therapeutics School of Medicine National and Kapodistrian University of Athens Athens Greece

Department of Haematology and Oncology Internal Medicine 5 Innsbruck University Hospital and Syndena GmbH Connect to Cure Innsbruck Austria

Department of Haematooncology University Hospital Ostrava and Faculty of Medicine University of Ostrava Ostrava Czech Republic

Department of Hematology Amsterdam UMC Location University of Amsterdam Cancer Center Amsterdam and LYMMCARE Amsterdam The Netherlands

Division of Hematology Fondazione IRCCS Policlinico San Matteo Pavia Italy

Hematology Department University Hospital of Salamanca Research Biomedical Institute of Salamanca Salamanca Spain

Hematology Division 1U AOU Città della Salute e della Scienza di Torino Torino Italy

Institute of Experimental Cancer Research Comprehensive Cancer Center Ulm University Hospital of Ulm Ulm Germany

Institute of Pathology and Comprehensive Cancer Centre Eberhard Karls University University Hospital Tübingen Tübingen Germany

Laboratory of Hematology Biology and Pathology Center CHU of Lille INSERM UMR S 1277 Team 4 Oncolille Lille France

Maria Sklodowska Curie National Research Institute of Oncology Krakow Poland

National and Kapodistrian University of Athens School of Medicine Athens Greece

Service d'Hematologie Clinique et Therapie Cellulaire Centre Hospitalier Universitaire d'Amiens Picardie Amiens France

The Leeds Teaching Hospitals National Health Service Trust Leeds UK

Unit of Hematology Department of Biotechnology and Health Sciences University of Torino Torino Italy

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