CZECHIA’S REFERENCE CENTER CONTACT INFORMATION
FRANCE’S REFERENCE CENTER CONTACT INFORMATION
GERMANY’S REFERENCE CENTER CONTACT INFORMATION
GREECE’S REFERENCE CENTER CONTACT INFORMATION
ITALY’S REFERENCE CENTER CONTACT INFORMATION
SWEDEN AND NORDIC COUNTRIES’S REFERENCE CENTER CONTACT INFORMATION
THE NETHERLANDS’S REFERENCE CENTER CONTACT INFORMATION
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The clonotypic B cell receptor immunoglobulin (BcR IG) is critically implicated in the pathogenesis of chronic lymphocytic leukemia (CLL). This is supported by the subdivision of patients with CLL in two categories with markedly different clinical behavior and outcome based on the load of somatic hypermutations (SHM) across the sequence of immunoglobulin heavy variable (IGHV) gene of the clonotypic BcR IG. In specific, patients with no or few SHMs within their IGHV genes (germline identity against the closest germline gene ≥ 98%; “unmutated” CLL, U-CLL) experience a significantly more aggressive disease than those with a significant SHM load (germline identity < 98%; “mutated” CLL, M- CLL). Besides these two main categories, there is also “borderline-mutated” CLL (germline identity of 97- 97.99%), which concerns a mixed group of cases with indolent and aggressive disease, underscoring the need of close follow-up of these patients.
IGHV gene mutational status is one of the most robust prognostic markers in CLL, readily identifiable at diagnosis and independent of clinical stage or other biomarkers. More importantly, it remains stable over time and has a strong predictive value for response to treatment. The important role of robust immunogenetic characterization in the proper management of patients with CLL is reflected in the most recent guidelines of the International Workshop on CLL (iwCLL) indicating that this biomarker should be assessed prior to treatment in all patients with CLL, i.e., in both general practice and clinical trials. CLL is notable for the existence of BcR IG stereotypy that defines subsets of patients with shared immunogenetic features and consistent clinicobiological profiles. From a clinical perspective, the most notable examples are stereotyped subsets #2 and #8. Subset #2 is associated with aggressive disease regardless of the SHM status: information regarding subset #2 membership is already used for stratifying patients in clinical trials (e.g. UK CLL FLAIR study). Subset #8 displays the highest risk for Richter’s transformation amongst all CLL, prompting specific recommendations regarding clinical management.
Given the obvious importance of BcR IG analysis for clinical decision making in CLL, ERIC, the European Research Initiative on CLL, has taken several initiatives for promoting good practices (Agathangelidis et al. Jove 2018) and providing standardized guidelines to the international scientific community (Agathangelidis et al. Leukemia 2022).
ERIC aims to promote and/or advance the analysis of the clonotypic BcR IG, including the determination of IGHV gene mutational status and the assessment to major stereotyped subsets #2 and #8 for diagnostic and prognostication purposes by educating the hematological community about:
- the need for performing immunogenetic analysis of the BcR IG in all CLL cases
- the quality of the appropriate experimental and analytical techniques to be utilized by diagnostic laboratories to ensure reliable and comparable results across different institutions in Europe and abroad.
Ultimately, this will improve optimal patient care and will increase the availability of relevant tests, allowing clinical study groups, as well as the pharmaceutical industry, to properly identify particularly difficult-to-treat CLL patients in routine diagnostics and clinical trials with the aim to further improving long-term outcomes.
The ERIC IG Network aims to be relevant to all personnel working in laboratories performing diagnostics for patients with CLL, including those who have never performed these analyses in the past, those who have recently introduced novel diagnostics and need reassurance on the accuracy of the procedure, and those already experienced in their use who want to keep high quality of applied methodologies. It also aims to increase physicians’ awareness of the need to test all CLL patients requiring therapy in order to select the most appropriate treatment for each case.
WORKING PLAN AND SPECIFIC OBJECTIVES
The ERIC IG Network accomplishes its goals using the following approaches:
- RECOMMENDATIONS ON IG GENE ANALYSIS
- EDUCATIONAL EVENTS
- ESTABLISHMENT AND EXPANSION OF THE IG NETWORK
- CERTIFICATION OF IG GENE ANALYSIS
- ONLINE WEBTOOLS
- ONLINE HELP DESK
The online help desk has been specifically set up for laboratories facing any difficulties during the analysis. It provides methodological as well as interpretation consultation.
- IG GENE ANALYSIS TEMPLATE REPORT FORM
This template serves as an example of the correct and comprehensive result report that should be provided to the physicians.
- A MANUAL FOR IG GENE ANALYSIS
This manual contains concise information on the IG GENE analysis process from sampling to data interpretation.
- CZECHIA
- FRANCE
- GERMANY
- GREECE
- ITALY
- SWEDEN AND NORDIC COUNTRIES
- THE NETHERLANDS
- GREECE
Sequences from both forward and reverse strand should be included.
How long does the lab have to analyse the samples?
Normally two months. Deadlines will be outlined.
How long for results to be sent after submitting the results?
Deadline will be provided.
How should the results be submitted?
Via an online personalised form that you will be sent.
Who should I contact if I need assistance?
Please email the ERIC Office.
How long is the certification valid for?
Three years.
How can I renew my certification?
Renewals are made by GenQA and UK NEQAS LI. You can find all the information here.
How can I certify my lab?
Please complete the Participation Form
How long does it take to receive participation confirmation?
You will be contacted via email. This may take a few weeks.
Who decides whether my lab can participate?
The certifying centre in charge of the Round.
What happens if there are no more spaces available?
Your lab will be included in the next available Round.
Is Certification free?
Yes it is. All courier costs are covered by ERIC.
How many certification rounds are there per year and when will the next one be?
Normally 2 per year: one gDNA-based and one RNA/cDNA-based.
How long is the certification valid for?
Three years.
How can I renew my certification?
Renewals are made by GenQA and UK NEQAS LI. You can find all the information here.
How can I request a duplicate certificate?
Please contact the ERIC Office at office@ericll.org
Which type of certification exists?
Standard.
How many times can my lab reapply if unsuccessful?
There is no limit.
How can I find out more about certified labs?
Please click on the Certified centres and Certification Round sections on the website.
When will the samples be sent?
You will be informed via email.
How many samples will be sent?
You will receive five samples.
Which type of nucleic acid will be tested?
There is one round for DNA and another one for RNA/cDNA per year.
Can my lab test both DNA and RNA?
Yes, but for your lab to receive certification, both of these methods must pass.
Buenos Aires, Centro de Hematología Pavlovsky (June 2017)
Buenos Aires, Leb Laboratorio (September 2023)
Bedford Park, SA Pathology (September 2016)
Bedford Park, GENOMIX (July 2023)
Melbourne, Peter MacCallum Cancer Centre (November 2020)
Sidney, Royal North Shore Hospital (July 2021)
Innsbruck, University Hospital Innsbruck ZIMCL (November 2020)
Inssbruck, Institute of Human Genetics-Medical University of Innsbruck (September 2022)
Linz, LMGD – Labor für Molekulargenetische Diagnostik (July 2021)
Linz, Ordensklinikum Linz (July 2023)
Salzburg, LIMCR / Krebsforschungslabor (February 2018)
Vienna, Medical University of Vienna (December 2018)
Brugge, AZ Sint-Jan Brugge (July 2023)
Brussels, Erasme Hospital (June 2017)
Brussels, Universitair Ziekenhuis Brussel (December 2018)
Liege, CHU Liège (January 2021)
Leuven, UZ Leuven (June 2017)
Nova Lima, Geneticenter (September 2022)
Rio de Janeiro, GeneOne – DIAGNÓSTICOS DA AMÉRICA S. A. (January 2023)
São Paulo – Fleury (October 2023)
São Paulo – Laboratório de Biologia Tumoral -HCFMUSP (August 2023)
Sofia, IMDL “Genome Center Bulgaria” (December 2022)
Montreal, Jewish General Hospital (January 2021)
Sudbury, Health Sciences North (November 2020)
Vancouver, Vancouver General Hospital Cytogenomics Laboratory (July 2021)
Santiago, Instituto Oncológico FALP (April 2024)
Beijing, Peking University People’s Hospital (September 2022)
Nanjing, Jiangsu Province Hospital (September 2022)
Suzhou, The First Affiliated Hospital of Soochow University (September 2022)
Suzhou, Suzhou Jsuniwell Medical Laboratory (August 2023)
Zagreb, University Hospital Centre Zagreb (July 2021)
Nicosia, Karaiskakio Foundation (September 2016)
Brno, University Hospital Brno (November 2020)
Hradec Kralove, Faculty Hospital (September 2016)
Novy Jicin, Laboratore AGEL a.s. (September 2016)
Olomouc, University Hospital Olomouc (August 2021)
Prague, UKHT Praha (IHBT Prague) (November 2020)
Prague, University Hospital Kralovske Vinohrady, Laboratory of Genomic Medicine (April 2024)
Aalborg, Aalborg University Hospital (April 2024)
Copenhagen, Rigshospitalet (April 2024)
Herlev, Herlev Hospital (June 2017)
Tartu, Tartu University Hospital (April 2024)
Turku, Hospital District of Southwest Finland (November 2020)
Besancon, EFSBFC-INSERM UMR1098 (September 2016)
Bobigny, Hôpital Avicenne (December 2020)
Lille, CHU de Lille (January 2021)
Montpellier, CHU Montpellier (June 2017)
Nantes, Nantes University Hospital (July 2023)
Paris, Hôpital Pitié-Salpêtrière (December 2018)
Pessac, Centre Hospitalier Universitaire de Bordeaux (July 2021)
Reims, L’Hôpital Robert Debré – CHU de Reims (September 2016)
Strasbourg, Hopitaux Universitaire de Strasbourg (November 2020)
Cologne, University Hospital Cologne (October 2019)
Dortmund, MVZ Labor Dr Eberhard & Partner (July 2021)
Dresden, Agendix GmbH (February 2018)
Giessen, Justus-Liebig-Universität Gießen (October 2019)
Göttingen, Universitätsmedizin Göttingen, INDIGHO Labor (July 2021)
Göttingen, Universitätsmedizin Göttingen Georg-August-Universität Klinik Für Hämatologie (April 2024)
Hamburg, Institut Für Haemotopathologie (September 2022)
Hannover, Hannover Medical School (January 2021)
Karlsruhe, MVZ Labor PD Dr. Volkmann & Kollegen GbR (April 2024)
Kiel, Hämatologie Labor Kiel, UKSH (February 2018)
Mannheim, LHO (November 2022)
Munich, MLL Münchner Leukämielabor GmbH (October 2023)
Ulm, Universitätsklinikum Ulm (December 2020)
Rostock, MVZ für Humangenetik und Molekularpathologie GmbH (April 2024)
Athens, BioAnalytica GenoTypos S.A. (September 2016)
Athens, National and Kapodistrian University of Athens (July 2023)
Pireaus, Nikea General Hospital (September 2016)
Thessaloniki, G. Papanicolaou Hospital (September 2016)
Hong Kong, Prince of Wales Hospital (July 2023)
Hong Kong, Tuen Mun Hospital (August 2023)
Budapest, Central Hospital of Southern Pest (August 2021)
Budapest, Semmelweis University (June 2017)
Debrecen, University of Debrecen (August 2021)
Dublin, St. James’s Hospital (November 2020)
Ashdod, Assuta Ashdod Hospital (July 2021)
Haifa, Rambam Medical Center (April 2024)
Haifa, The Simon Winter Institute for Human Genetics – The Bnai-Zion Medical Center (November 2020)
Kfar Saba, Meir Medical Center (February 2020)
Petach Tiqwa, Rabin Medical Center (February 2018)
Ramat Gan, Sheba Hospital (December 2020)
Tel Aviv, Tel Aviv Sourasky Medical Center (July 2021)
Zrifin, Shamir Medical Center (April 2024)
Ancona, AOR Ospedali Riuniti-Univpm Ancona (July 2021)
Ascoli Piceno, Asur 5 Ospedale “Mazzoni” di Ascoli Piceno (February 2018)
Aviano, I.R.C.C.S. Centro di Riferimento Oncologico (February 2018)
Bari, IRCCS Istituto Tumori “Giovanni Paolo II” di Bari (July 2021)
Bari, University of Bari (June 2017)
Bergamo, Asst Papa Giovanni XXIII (July 2023)
Cagliari, Ospedale Oncologico Armando Businco (December 2020)
Cosenza, UOC di Ematologia, A.O. Annunziata di Cosenza (December 2018)
Brescia, ASST Spedali Civili di Brescia – Lab Crea (June 2017)
Ferrara, University of Ferrara (June 2017)
Genova, Ospedale Policlinico Sanmartino (July 2021)
Meldola, IRST IRCCS (December 2020)
Milano, Grande Ospedale Niguarda (June 2017)
Milano, IRCCS Ospedale San Raffaele (November 2020)
Milano, Policlinico di Milano (December 2018)
Modena, Azienda Ospedaliera-Universitaria di Modena (January 2021)
Napoli, CEINGE Oncohematology Laboratory (July 2021)
Napoli, Istituto Nazionale Tumori di Napoli IRCCS -“G.Pascale” (April 2024)
Novara, Università del Piemonte Orientale (July 2023)
Nuoro, San Francesco Hospital, ASL Nuoro (November 2022)
Padova, Università degli Studi di Padova (September 2021)
Palermo, AO Villa Sofia Cervello (December 2018)
Pavia, Fondazione IRCCS Policlinico San Matteo (July 2021)
Perugia, University of Perugia (November 2020)
Pescara, Università Chieti – Pescara (February 2020)
Piacenza, AUSL Piacenza (December 2020)
Rome, A. O. San Camillo Forlanini (November 2020)
Rome, Sapienza University (February 2018)
Torino, SC Anatomia e Istologia Patologica 1U (December 2020)
Vicenza, San Bortolo Hospital (February 2020)
Amman, King Hussein Cancer Center (August 2023)
Vilnius, Vilnius University Hospital Santaros Klinikos (November 2020)
Kaunas, Hospital of Lithuanian University of Health Sciences Kauno (September 2022)
Skopje, UKIM – Faculty of Pharmacy (September 2016)
Amsterdam, Academic Medical Center, University of Amsterdam (July 2023)
Amsterdam, Sanquin Diagnostics Services (November 2020)
Nijmegen, Radboud University Medical Centre Nijmegen (September 2016)
Rotterdam, Erasmus University Medical Centre (September 2016)
Utrecht, UMC Utrecht (July 2021)
Zwolle, Isala (April 2024)
Oslo, Oslo University Hospital HF (April 2024)
Gdansk, Laboratory of Hematology, University Clinical Centre in Gdansk (April 2024)
Lodz, Wojewódzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopernika W Łodzi (September 2023)
Lublin, Medical University of Lublin (September 2016)
Poznań, Zakład Diagnostyki Medycznej Sp. z o.o. (May 2024)
Rzeszow, Uniwersytecki Szpital Kliniczny W Rzeszowie (April 2024)
Warzawa, Institute of Hematology and Transfusion Medicine, Molecular Biology Laboratory (November 2022)
Warszawa, Medical University of Warsaw (November 2022)
Warszawa, Narodowy Instytut Onkologii Im. Marii Skłodowskie-Curie – Państwowy Instytut Badawczy (April 2024)
Coimbra, Centro Hospitalar e Universitário de Coimbra (July 2021)
Lisbon, Instituto Português de Oncologia de Lisboa (September 2022)
Lisbon, Genomed – Diagnósticos de Medicina Molecular (January 2021)
Moscow, National Research Center for Hematology (September 2016)
Saint Petersburg, Almazov NW Federal Research Center (September 2016)
Saint Petersburg, Pavlov First State Medical University of St. Petersburg (January 2021)
Bratislava, Národný Onkologický Ústav (October 2019)
Ljubljana, University Medical Centre Ljubljana (June 2017)
Capetown, UNISTEL (January 2021)
Pretoria, Oncolab (September 2022)
Barcelona, Fundación IMIM (June 2017)
Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer, IDIBAPS (September 2022)
Barcelona, Hospital de St. Pau (June 2017)
Barcelona, Hospital Universitari Vall d’Hebron (July 2021)
Gran Canaria, Hospital de Gran Canaria Dr. Negrín (June 2017)
Majadahonda, Hospital Puerta de Hierro-Majadahonda (February 2018)
Salamanca, Centro de Investigación del Cáncer (February 2018)
Salamanca, Hospital Universitario de Salamanca (October 2019)
Valencia, Hospital Clínico Universitario (September 2022)
Goteborg, Sahlgrenska University Hospital (September 2016)
Uppsala, Uppsala University (June 2017)
Bellinzona, Laboratorio di Diagnostica Molecolare EOLAB (November 2020)
Bern, Inselspital University Hospital Bern (June 2017)
Bioggio, SYNLAB Suisse SA (December 2018)
Lausanne, Centre Hospitalier Vaudois (July 2021)
Lausanne, Unilabs (November 2020)
Taipei, National Taiwan University Hospital (June 2017)
Istanbul, Koc University Hospital (September 2022)
Belfast, Belfast City Hospital (February 2018)
Bournemouth, Royal Bournemouth Hospital (September 2016)
Cambridge, Addenbrookes Hospital (February 2018)
Edinburgh, NHS Lothian (February 2020)
Leeds, Leeds Institute of Oncology (December 2018)
Leeds, Leeds Teaching Hospitals (April 2024)
Liverpool, Royal Liverpool University Hospital (September 2016)
London, Synnovis (September 2023)
Southampton, University of Southampton Hospital Trust (September 2023)
Southampton, Molecular Pathology, University Hospital Southampton (November 2021)
Sutton, The Royal Marsden NHS Foundation Trust (February 2018)
Whitechapel, Barts Health NHS Trust (February 2020)
Bethesda MD, National Cancer Institute (February 2021)
Houston TX, NeoGenomics (June 2021)
Morrisville NC, Q2 Solutions (February 2017)
Morrisville NC, Flagship Biosciences (July 2021)
How long does the lab have to analyse the samples?
Normally two months. Deadlines will be outlined.
How long for results to be sent after submitting the results?
Deadline will be provided.
How should the results be submitted?
Via an online personalised form that you will be sent.
Who should I contact if I need assistance?
Please email the ERIC Office.
How long is the certification valid for?
Three years.
How can I renew my certification?
Renewals are made by GenQA and UK NEQAS LI. You can find all the information here.
How can I certify my lab?
Please complete the Participation Form
How long does it take to receive participation confirmation?
You will be contacted via email. This may take a few weeks.
Who decides whether my lab can participate?
The certifying centre in charge of the Round.
What happens if there are no more spaces available?
Your lab will be included in the next available Round.
Is Certification free?
Yes it is. All courier costs are covered by ERIC.
How many certification rounds are there per year and when will the next one be?
Normally 2 per year: one gDNA-based and one RNA/cDNA-based.
How long is the certification valid for?
Three years.
How can I renew my certification?
Renewals are made by GenQA and UK NEQAS LI. You can find all the information here.
How can I request a duplicate certificate?
Please contact the ERIC Office at office@ericll.org
Which type of certification exists?
Standard.
How many times can my lab reapply if unsuccessful?
There is no limit.
How can I find out more about certified labs?
Please click on the Certified centres and Certification Round sections on the website.
When will the samples be sent?
You will be informed via email.
How many samples will be sent?
You will receive five samples.
Which type of nucleic acid will be tested?
There is one round for DNA and another one for RNA/cDNA per year.
Can my lab test both DNA and RNA?
Yes, but for your lab to receive certification, both of these methods must pass.