Members
The terms of reference

The members of the Scientific Committee are the chairs of the different working groups whereas the chair of the SC is directly appointed by the Executive Board.

Members

Name	Contact
Chair Sverre Sandberg second term 2011-2013	Laboratory of Clinical Chemistry Haukeland University Hospital N-5021 Bergen Norway E-Mail
Päivi Laitinen first term 2011-2013	HUSLAB Clinical Chemistry and Haematology P.O. Box 340 00290 Helsinki Haartmaninkatu 4 Phone:+358 50 427 9208 E-Mail
Ana-Maria Simundić first term 2011-2013	University Dept. of Chemistry University Hospital “Sestre Milosrdnice” Vinogradska 29 10000 Zagreb Croatia Tel.: +385-1-3787184 Fax: +385-1-3768280 Mobile: +385-99-2554708 E-Mail
William A. Bartlett second term 2011-2013	Blood Sciences Ninewells Hospital & Medical School DD1 9SY Dundee United Kingdom Tel.: +44-1382-632512 Fax: +44-1382-645333 Mobile: +44-777-4103338 E-Mail E-Mail
Wytze Oosterhuis second term 2011-2013	Dept Clinical Chemistra Atrium Medical Center Henri Dunantstraat 5 6419 PC Heerlen The Netherlands Tel.: +31-455766341 Fax: +31-455676575 Mobile:+31-625065465 E-Mail
Andrea R. Horváth first term 2010-2012	SEALS North Department of Clinical Chemistry Prince of Wales Hospital Barker Street Randwick, NSW 2031 Sydney Australia Tel.: +61-2-93829078 Fax: +61-2-93829099 Mobile: +61-404027843 E-Mail
Éva Ajzner first term 2013-2014	Sz-Sz-B County’sTeaching Hospital Central Laboratory Szt Istvan Street 68 H-4400 Nyíregyháza – Hungary E-Mail: ajznereva@josa.hu

The terms of reference

The Scientific Committee is responsible for scientific matters within EFLM and projects which further the scientific development of EFLM (except those specifically related to quality management, which are the responsibility of the Quality Management Committee). Activities of the Committee should particularly focus on promotion of research that translates the scientific results of clinical chemistry and laboratory medicine to clinical applications and improves patient outcomes through the appropriate use and interpretation of laboratory data in clinical practice.

The Scientific Committee will work towards the following general goals of EFLM:

• To promote and improve science and education within the field of clinical chemistry and laboratory medicine.
• To improve patient outcomes and the quality and safety of patient care through the highest standards of laboratory medicine.

The Scientific Committee will deliver the following specific objectives of EFLM:

• Promoting scientific co-operation in clinical chemistry and laboratory medicine between European institutions and other organizations within and outside Europe.
• Co-operation in defining European guidelines for the investigation and laboratory management of diseases.
• Harmonising standards of practice in scientific matters through production of guidance documents stating best practice in areas of clinical chemistry and laboratory medicine.
• Developing European initiatives on the standardization of laboratory data.

To achieve the above, the Committee may consider pre-analytical, analytical and post-analytical matters within its remit, and will also advise on the exploitation of basic research, evaluation of new biomarkers and their translation into routine clinical practice. The Scientific Committee will have direct links to the Scientific Division of IFCC, and will also seek to maintain an overview of scientific projects being undertaken in National Societies.

The Scientific Committee will collaborate with relevant clinical and scientific societies, and will also take part in international collaborative projects involving EFLM member societies.

The Scientific Committee will organize and participate in international clinical audit projects and surveys, and will also engage in guideline development in co-operation with relevant clinical organizations.

Results of the Committee’s work will be actively disseminated at conferences and workshops, published in scientific journals (e.g. CCLM) and available on the EFLM web site. Dissemination will be carried out in co-operation with the Education and Training Committee, within the limits of available resources.

Name	Contact
Chair Mario Pazzagli first term 2013-2014	Department of Clinical Physiopathology University of Florence, ITALY E-Mail: m.pazzagli@dfc.unifi.it
Member Ivan Brandslund first term 2013-2014	Department of Clinical Biochemistry Vejle Hospital, DENMARK E-Mail: ivan.brandslund@slb.regionsyddanmark.dk
Member Pieter Vermeersch first term 2013-2014	Laboratory Medicine University Hospitals Leuven, BELGIUM E-Mail: pieter.vermeersch@uzleuven.be

Terms of reference
To define the role and responsibilities of medical laboratories in procedures linked to personalized medicine approaches in cancer. This could be achieved by developing scientific publications or guidance on:
– the recent improvements in analytical techniques (mainly genomics), linked to the rapidly increasing knowledge on biological mechanisms;
– the improvements and requirements in the corresponding computing resources;
– specific oncological pathologies describing the process of the use of co-dependent technologies (including laboratory tests) for the management of individual patients;
– the potentials and limitations of the most recent laboratory technologies applied in personalized medicine;
– setting competency standards for staff involved in testing; or
– specifying professional criteria for quality goals and for accreditation in this field.

Name	Contact
ad Interim Chair Ian Watson 2013	Department Clinical Biochemistry University Hospital Aintree Longmoor Lane L9 7AL Liverpool United Kingdom Tel.: +44 151 529 3575 Fax: +44 151 529 3310 E-Mail
Member Joel Corberand first term 2013-2014	Haematology Department Rangueil Hospital 1 Avenue Jean Poulhès Toulouse France E-Mail: corberand.j@chu-toulouse.fr
Member Per Jørgensen one year term 2013	Glostrup Hospital Ndr. Ringvej 57 2600 Glostrup Denmark E-Mail: per.joergensen.01@regionh.dk
Member Wytze Oosterhuis first term 2013-2014	Dept Clinical Chemistry Atrium Medisch Centrum Henri Dunantstraat 5 6419 PC Heerlen The Netherlands E-Mail: w.oosterhuis@atriummc.nl
Member Young Scientist Joanna Pollak first term 2013-2014	Dept of Laboratory Medicine University of Nicolaus Copernicus Collegium Medicum M. Sklodowskiej – Curie 9 85-094 Bydgoszcz Poland E-Mail: asiapollak@wp.pl
Corresponding Member Z. Gunnur Dikmen first term 2013-2014	Dept of Biochemistry University of Hacettepe 06100 Ankara Turkey E-Mail: zgunnur@gmail.com
Corresponding Member Snezana Jovicic first term 2013-2014	Center for Medical Biochemistry Clinical Center of Serbia Visegradska 26 11000 Belgrade Serbia E-Mail: hionati@gmail.com

Terms of reference

1. Evaluate and study methods for how specialists in laboratory medicine can communicate directly with the patients;
2. Evaluate and study how the laboratory can play an active role in patients using self-monitoring for monitoring their disease.

Action Plan 2013

1. Carry out a survey among European countries to evaluate what (if any) activity the EFLM member states have in the two areas above;
2. Perform a study to evaluate the usefulness of a direct report of laboratory data to the patient.

Aim

To perform a European survey on what critical result management procedures and policies laboratories have and how critical values are established and used in European laboratories.

Deliverables

To publish at least one scientific paper about the subject and to give a presentation or poster at EuroMedLab or other EFLM and/or AACB-related conference or symposium.

Members

SPIDIA
EUmetaLAB

SPIDIA

The Spidia Project‘s main aim is the development of standards for patient sample processing in order to facilitate the discovery and prediction of diseases.

EFLM will participate in the SPIDIA Project supporting the process of standardization and of the dissemination of the results.

Background

The European Union has launched a new research project targeting to expand the potentials and utility of in-vitro diagnostics through the creation of new standards for the collection, handling and processing of blood, tissue, tumor and other sample materials. Under the 7th Framework Programme, the European Commission approved the initiative’s funding and scope to develop corresponding standards, tools and quality assurance schemes. The SPIDIA project (“Standardization and improvement of generic Pre-analytical tools and procedures for In-vitro Diagnostics”) is scheduled to run for four years and has a total budget of over 13 million Euros. The consortium, consisting of a total of 16 companies and research institutions from 11 countries, will be led by QIAGEN, Europe’s largest biotechnology company and a global leader in molecular sample and assay technologies.

The project has been set up to standardize the pre-analytical handling of patient samples used for in-vitro diagnosis of human diseases. The EU Commission has recognized that in “in-vitro” diagnostics, the collection, handling and processing of sample materials are regarded as particularly critical procedures, as the reliability of the subsequent analysis and therefore the meaningfulness of the diagnosis are vitally dependent upon the integrity of the sample.

This seems particularly relevant for the so-called “Molecular Diagnostics”, in which DNA, RNA or proteomic analysis will play a particularly vital role in future healthcare in Europe. It is believed that these new diagnostics should allow earlier and more reliable information about the status of a disease than conventional methods. Molecular diagnostics can also facilitate predictions concerning the future courses of diseases and lead to individualized therapeutic measures. They are therefore viewed as fundamental to the emergence of the new era of personalized medicine.

EFLM and SPIDIA

EFLM welcomes the SPIDIA initiative and it is interested in playing a role in the project for a significant expansion of the potential of in-vitro diagnostics and in particular in supporting the process of the standardization of the collection, handling and processing of biological samples and in the dissemination of the results of this project. With its support of this project, the EFLM is providing strong leadership in emphasizing the importance of these processes in general and molecular diagnostics and their role as cornerstones of future healthcare in Europe. Specific activities of EFLM in supporting the SPIDIA Project will be soon described in this web site.

About SPIDIA

The SPIDIA project (Standardization and improvement of generic Pre-analytical tools and procedures for In-vitro Diagnostics) is a Consortium of 16 members from 11 countries, including companies such as TATAA BIOCENTER AB, PreAnalytiX GmbH (a QIAGEN/BD Company), DIAGENIC ASA, Aros Applied Biotechnology A/S, Dako Denmark A/S, ACIES, ImmunID Technologies, academic partners such as universities and research institutes in Munich, Florence, Graz, Prague and Rotterdam. The International Agency for Research and Cancer and the European Standardization Committee are also members of the project, which is being led by QIAGEN GmbH in Hilden. EFLM role in the SPIDIA Project is recognized with a subcontracting for specific activities addressing topics on Standardization and Dissemination. The project is being sponsored as part of the European Union’s 7th framework programme.

EUmetaLAB

EU-wide interdisciplinary Metastructure for the Generation and Support of multicentric clinical Research Studies

The background problem

Biotechnology is considered the most important new areas of technology for the 21st century and already has gained profound impact on life sciences and medicine. In order to identify disease mechanisms, devise new therapeutic strategies and provide health benefit for the individual patient citizen, modern medicine increasingly uses advanced high-throughput technologies that have emerged over the last 20 years. To employ these technologies, archived samples from biomaterial resources have become an important source for translational and clinical research studies, and numerous biobanks have been established over the last years. A Europe-wide biobanking network is a logical concept possessing high potential to foster European research and eventually improve health care. However, major challenges include harmonization and standardization of future biomaterial archives for later translational research and scientific clinical studies – a challenge by far not met at present.

Indeed, harmonization of existing biobank is a very difficult task due to highly specialized laboratory data and medical context data sets (e.g. when collected in different context like arteriosclerosis or cancer or when designed with different perspectives). Accordingly, the overlapping information generated from these biobanks may be limit mutual use. With respect to the development of future biobanking projects on supranational scale, biobanking partners will need rigorous standardization of sampling, processing and archiving. Again, consented standards are far from being defined. Another issue is the time needed to develop biobanking networks (each then still representing research projects dedicated to single or few disease entities) to grow to representative sizes suitable for large studies. Finally, bioanalytes behave differently under archiving conditions. For example, while DNA is “basically indestructible” in a biosample, instable biomarkers like RNA, proteins, metabolites or whole cells are very delicate.

The EUmetaLAB project

EUmetaLAB represents an ambitious concept to support scientific Laboratory Medicine, multicentric scientific studies and assist biobanking initiatives. EUmetaLAB is embedded in the European Society for Clinical Chemistry (EFLM). The project will aim at the standardization in management and processing of routine clinical biosamples (mainly serum and plasma) received by Clinical Chemistry laboratories. Clinical Chemistry and Laboratory Medicine are central to public health care throughout Europe, as they provide clinicians with critical medical information. Clinical laboratories process by far the largest numbers of blood samples every day.
EUmetaLAB´s presumption is that within clinical labs the sample handling, monitoring and archiving already has reached a high level of standardization, thus allowing the definition of comparable routine procedures that result in biosamples of homogeneous qualities. In addition, modern clinical laboratories use comparable analytical methods and machinery allowing to assess and to compare sample qualities. Finally, most laboratories run extensive quality management systems ranging from internal control to participation in external quality assessment and to accreditation allowing to constantly monitor their analytical and professional proficiency.

EUmetaLAB aims at networking European academic clinical laboratories to provide the backbone for future multicentric biomaterial sampling (a laboratory metastructure) in a standardized manner. In contrast to the local disease-oriented biobanking, EUmetaLAB is highly dynamic, adjustable to changes and responsive to scientific requests for biomaterial on a multicentric scale. Of advantage is the high-throughput sample flow covering all diseases and disease states observable in Europe.

The backbone of EUmetaLAB is the „NetPoint“ consisting of laboratory and the clinical unit sending diagnostic samples (Fig.1). Clinical units provide medical context data with the samples. EUmetaLAB samples consists of three components that can be delivered for scientific studies: the pseudonymized sample in standardized quality, the lab data set containing routine clinical laboratory test results and a basic medical context data set including medical information on condition together environmental information for stratification. The sets are consented between NetPoints and follow standardize EUmetaLAB procedures and internal quality guidelines.

Fig. 1: Harmonization of laboratory and clinical aspects in an individual NETpoint (vertical harmonization) and between all NETpoints (horizontal harmonizations) as proposed by EUmetaLAB

The EUmetaLAB procedures ensure that samples with equal quality can be provided from the different NetPoints in Europe (e.g. in Helsinki and Lisboa). SOPs exist or will be established for rapid adjustments of these sets related to requests by the studies. Existing External Quality Assessment (EQA) schemes will be used to ensure comparability of laboratory routine test results from different NetPoints. In addition, novel EQA programs will be implemented to monitor specific EUmetaLAB activities for quality verification and harmonization. An IT framework will be needed and implemented in EUmetaLAB for communication within the network. EUmetaLAB server and website will be implemented to provide all information required to schedule its cooperation with studies and other biomaterial resources.

Members

Name	Contact
Chair Andrea R. Horváth second term 2013-2014	SEALS North, Department of Clinical Chemistry Prince of Wales Hospital Barker Street Randwick, NSW 2031 Sydney – Australia Tel.: +61-2-93829078 Fax: +61-2-93829099 Mobile: +61-404027843 E-Mail: rita.horvath@sesiahs.health.nsw.gov.au
Member Christa Cobbaert second term 2013-2014	Dept of Clinical Chemistry Leiden University Medical Center Albinusdreef 2 NL 2300 RC Leiden – The Nederland Tel.: +31-71-5264483 Tel.: +31-71-5266753 E-Mail: c.m.cobbaert@lumc.nl
Member Andrew St. John first term 2012-2014	Perth Australia E-Mail: astjohn14@gmail.com
Member Sally Lord first term 2013-2014	NHM RC Clinical Trials Centre The University of Sidney – Autralia Tel.: +61-2-95625322, Fax: +61-2-95651863 E-Mail: sally.lord@ctc.usyd.edu.au
Member Young Scientist Dr Phillip J Monaghan first term 2012-2014	Department of Clinical Biochemistry The Christie Hospital NHS Foundation Trust Wilmslow Road Withington, Manchester, M 20 4BX, UK Tel.: 0044-161-446 3298 E-Mail: phillip.monaghan@nhs.net
Corresponding Member Alexey Bugrov first term 2012-2014	Dept. of Clinical Laboratory Diagnostics Russian Medical Academy of Postgraduate Education 125424 P.O.B. Moscow 32, Russia Tel.: 0079-265769490 Fax: 0074-959458400 E-Mail: avb81@bk.ru
Expert/Consultant Sverre Sandberg	Laboratory of Clinical Biochemistry Haukeland University Hospital NO 5021 Bergen – Norway E-Mail: sverre.sandberg@isf.uib.no
Expert/Consultant Patrick Bossuyt	Amsterdam – The Netherlands E-Mail: p.m.bossuyt@amc.nl
Expert/Consultant Lieselotte Lennartz	Scientific Affairs Manager EMEA (Europe, Middle East, Africa & India ) Abbott GmbH & Co.KG Max-Planck-Ring 2 65205 Wiesbaden – Germany Tel.: +49(0)6122 58-2886 Fax: +49(0)6122 58-1668 Mobile: +49(0)151 14038965 E-Mail: l.lennartz@abbott.com
Expert/Consultant Wilma Verhagen-Kamerbeek	Clinical Science Leader Roche Diagnostics Ltd. Roche Professional Diagnostics DXC Medical Affairs, Forrenstraße 6343 Rotkreuz – Switzerland Tel.: +41(0)41 798 78 28 Fax: +41(0)41 798 72 29 E-Mail: wilma_dj.verhagen-kamerbeek@roche.com
Expert/Consultant Christoph Ebert	Head of Clinical Trials Roche Diagnostics Ltd. Roche Professional Diagnostics DXC Medical Affairs,Forrenstraße 6343 Rotkreuz – Switzerland Tel.: +41(0)41 798 78 28 Fax: +41(0)41 798 72 29 E-Mail: christoph.ebert@roche.com

EFLM Science Committee, Chair: Prof. Sverre Sandberg
Test Evaluation Working Group (WG-TE),

Chair: Prof. Andrea Rita Horvath
Email: rita.horvath@sesiahs.health.nsw.gov.au

EFLM’s Test Evaluation Working Group (WG-TE), established under its Science Committee, is a joint collaboration between EFLM and AACB (Australasian Association of Clinical Biochemistry). Membership of this WG represents collaboration between experts in evidence-based laboratory medicine, evidence-based diagnosis and epidemiology, and research and development of IVD industrial partners. The background, rationale and terms of reference of the working group are listed below.

Background and rationale

Clinical utilization and reimbursement for laboratory tests should move from a cost-based towards a value- and evidence-based approach. Laboratory tests have clinical value only if they provide benefit to patients at acceptable costs. Translational research aims to decrease the gap between the identification of new biomarkers and proving that these are clinically effective and improve patient-centred, organizational or economic outcomes. Nevertheless, new laboratory tests are often released to market with little evidence supporting their value or impact in clinical practice. Since resources are finite, evidence-based decisions about the use of diagnostic interventions should depend on well-designed and conducted test evaluation studies and technology appraisals.

After initial discovery of new biomarkers, careful consideration should be given to its purpose, the context and the clinical pathway for its application, the population and healthcare setting in which the test is intended to be used, and its potential consequences in clinical practice. No new test should be subjected to tedious evaluation if the test is unlikely to result in improved clinical actions or measurable outcomes. Test evaluation should be carried out with carefully planned study designs appropriate for the questions addressed at each stage of development. The below steps are proposed when investigating the value of testing: Basic research into the association of disease with the new biomarker; Research into the analytical and clinical performance of tests; Clinical research into the clinical application and effectiveness of tests; Impact of testing in practice.

The evidence-based methodology of these steps is not widely understood and there are now a number of published examples on the common pitfalls and potential biases in test evaluation studies that may lead to inappropriate medical decisions and threaten patient safety. Therefore the European Commission and IVD regulatory bodies have also acknowledged that a more responsive and proportionate risk assessment during pre-market approval of new tests is needed, which involves the review of the evidence for the clinical effectiveness and impact of new biomarkers.

Terms of reference:

1. To develop a framework and guidance for the appropriate evaluation of the clinical effectiveness and impact of new laboratory tests.
2. To develop practical toolboxes which support the design and conduct of clinical research trials for the above purposes.
3. Education and training of researchers via pilot biomarker studies on how to design test evaluation studies.
4. Collaboration with epidemiologists, industry and regulatory authorities in setting standards for clinical evaluation of new biomarkers.

Deliverables:

General guidance on the process of test evaluation studies and on the best study design for the clinical evaluation of new tests at various stages of the test development process.

Criteria for test evaluation studies depending on the purpose or intended clinical application of the new test (i.e. diagnosis, screening, monitoring, risk assessment, prognosis).

Minimum reporting criteria that can also be used by regulatory or approval bodies (e.g. FDA, CE marking) assessing the clinical value of new biomarkers.
Training materials and courses on diagnostic trial design and how to conduct high quality diagnostic studies.

Representation of EFLM’s above interests at relevant international forums and commenting the revision of the EU IVD Directive at EC level accordingly. (The latter will be carried out in collaboration with EFLM’s delegates to the EC Exploratory Process on Medical Devices and jointly with EFLM’s WG-IVD).

Members

Name	Contact
Chair Ana-Maria Simundic first term 2012-2014	University Dept. of Chemistry University Hospital “Sestre Milosrdnice” Vinogradska 29 10000 Zagreb, Croatia Tel.: +385-1-3787184 Fax: +385-1-3768280 Mobile: +385-99-2554708 E-Mail: am.simundic@gmail.com
Member Giuseppe Lippi first term 2012-2014	Clinical Chemistry and Hematology Laboratory Academic Hospital of Parma, Italy E-Mail: glippi@ao.pr.it
Member Kjell Grankvist first term 2012-2014	Dept. of Medical Biosciences, Clinical Chemistry Umea University Building 6M 2nd Floor S-90185 Umea – Sweden Tel.: +46-907851262, Fax: +46-907854484 E-Mail: kjell.grankvist@medbio.umu.se
Member Mads Nybo first term 2012-2014	Dept. of Clinical Biochemistry and Pharmacology Odense University Hospital Sdr. Boulevard 29 5000 Odense C – Denmark Tel.: +45-65411161 E-Mail: mads.nybo@ouh.regionsyddanmark.dk
Member Young Scientist Michael Cornes first term 2012-2014	The Royal Wolverhampton Hospitals NHS Trust New Cross Hospital Wednessfield Road Wloverhampton WV10 0QP – UK Tel.: +45-65411161 E-Mail: michael.cornes@nhs.net
Corresponding Member Pinar Eker first term 2013-2014	Umraniye Training And Research Hospital Istanbul, Turkey E-Mail: pinareker@yahoo.com
Corresponding Member Svetlana Kovalevskaya first term 2012-2014	Labstory Company Office 312 Saint Petersburg, Russia E-Mail: kovalevskaya@labstory.ru
Corresponding Member Gunn B.B. Kristensen first term 2012-2014	NKK– Norwegian Clinical Chemistry EQA Programme Bergen, Norway E-Mail: gunn.kristensen@noklus.no
Corresponding Member Ludek Sprongl first term 2012-2014	Central Laboratory Sumperska nemocnice a.s. Sumperk, Czech Rep. E-Mail: sprongl@nemspk.cz
Corresponding Member Zorica Sumarac first term 2012-2014	Center for Medical Biochemistry Clinical Center of Serbia Belgrade, Serbia E-Mail: zsumarac@open.telekom.rs
Corresponding Member Edmée van Dongen-Lases first term 2013-2014	Dept. of Clinical Chemistry Academic Medical Center Amsterdam, The Netherlands E-Mail: e.c.vanDongen-Lases@amc.nl
Expert/Consultant Stephen Church	Becton Diskinson E-Mail: stephen_church@europe.bd.com

Members

Members

Name	Contact
Chair WG-G Wytze Oosterhuis second term 2011-2013	Dept Clinical Chemistry Atrium Medisch Centrum Henri Dunantstraat 5 6419 PC Heerlen – The Netherlands Tel.: +31-455766341 Fax: +31-455676575 E-Mail: w.oosterhuis@atriummc.nl
Member Kristin Moberg Aakre second term 2011-2013	Laboratory of Clinical Biochemistry Haukeland University Hospital Jonas Lies vei 65 5021 Bergen – Norway Tel.: +47 55973155 E-Mail: kristin.moberg.aakre@helse-bergen.no
Member Joseph Watine second term 2011-2013	Biologie Polyvalente Hopital de la Chartreuse Avenue Caylet 12200 Villefranche-de-Rouergue, France Tel.: +33-565653131 Fax: +33-565653112 E-Mail: wjoseph61@hotmail.com
Member Julian H. Barth first term 2011-2013	c/o ACB 130-132 Tooley St London SE1 2TU, UK Tel.: +44-20-74038001 Fax: +44-20-74038006 E-Mail: Julian.Barth@leedsth.nhs.uk
Member Michel R. Langlois first term 2011-2013	Dept. of Laboratory Medicine AZ St. Jan Hospital Ruddershove 10, B-8000 Bruges, Beldium E-Mail: michel.langlois@azsintjan.be
Member Young Scientist Shivani Misra first term 2012-2014	Clinical Biochemistry 8th Floor East Wing Charing Cross Hospital Fullham Palace Road London, W6 8RF, UK E-Mail: s.misra@imperial.ac.uk
Expert/Consultant Ferruccio Ceriotti	Diagnostica e Ricerca San Raffaele S.p.A Via Olgettina 60 20132 Milano – Italy Tel.: +39-02-26432282 Fax: +39-02-26432640 E-Mail: sceriotti.ferruccio@hsr.it

Terms of reference

Co-operation in defining European guidelines for the investigation and laboratory management of disease by:

1. Prepare guidelines for making recommendations for laboratory testing
2. Co-operate with clinical guidelines developers (e.g. SIGN, ADA, NICE) for the development of the laboratory part of clinical guidelines
3. Develop laboratory guidelines for reflective testing

Members

Name	Contact
Chair Päivi Laitinen first term 2011-2013	HUSLAB Clinical Chemistry and Haematology P.O. Box 340 00290 Helsinki Haartmaninkatu 4 Tel: +358 50 427 9208 E-Mail: paivi.h.laitinen@hus.fi
Member Paul Collinson first term 2011-2013	St George’s Hospital Blackshaw Road SW17 0QT London United Kingdom Tel: +44-208-725-5934 E-Mail: paul.collinson@stgeorges.nhs.uk
Member Marja P. van Dieijen-Visser first term 2011-2013	Netherlands E-Mail: mp.van.dieijen.visser@mumc.nl
Member Angelika Hammerer-Lercher first term 2011-2013	Austria E-Mail: angelika.hammerer-lercher@uki.at
Member Kari Pulkki first term 2011-2013	Dept of Clinical Chemistry (Laboratory Medicine) School of Medicine, Univ. of Eastern Finland Kuopio Eastern Finland Laboratory Centre Joint Authority Enterprise, P.O. Box 1700 FIN-70211 Finland E-Mail: kari.pulkki@uef.fi E-Mail: kari.pulkki@islab.fi
Member Young Scientist Christopher Duff first term 2012-2014	Department of Biochemistry University Hospital of North Staffordshire Stoke-on-Trent, ST4 7PX – UK Tel: +44-1782-555195 E-Mail: chris.duff@uhns.nhs.uk
Corresponding Member Ana Stavljenic-Rukavena first term 2011-2013	Hungary E-Mail: ana.stavljenic-rukavina@zg.htnet.hr
Corresponding Member Michel Langlois first term 2011-2013	Belgium
Corresponding Member Kristin Moberg Aakre first term 2011-2013	Laboratory of Clinical Biochemistry Haukeland University Hospital Jonas Lies vei 65 5020 Bergen Norway Tel: +47 55973188 Fax: +47 55975976 E-Mail: kristin.moberg.aakre@helse-bergen.no
Corresponding Member Hannsjörg Baum first term 2012-2014	Klinikum Ludwigsburg Posilipostraße 4 571640 Ludwigsburg Germany Tel: +49 7141-9965800 Fax: +49-7141-9965819 E-Mail: hannsjoerg.baum@verbund-rkh.de: hannsjoerg.baum@verbund-rkh.de

Members
The terms of reference

The members of the Scientific Committee are the chairs of the different working groups whereas the chair of the SC is directly appointed by the Executive Board.

Members

Name	Contact
Chair Sverre Sandberg second term 2011-2013	Laboratory of Clinical Chemistry Haukeland University Hospital N-5021 Bergen Norway E-Mail
Päivi Laitinen first term 2011-2013	HUSLAB Clinical Chemistry and Haematology P.O. Box 340 00290 Helsinki Haartmaninkatu 4 Phone:+358 50 427 9208 E-Mail
Ana-Maria Simundić first term 2011-2013	University Dept. of Chemistry University Hospital “Sestre Milosrdnice” Vinogradska 29 10000 Zagreb Croatia Tel.: +385-1-3787184 Fax: +385-1-3768280 Mobile: +385-99-2554708 E-Mail
William A. Bartlett second term 2011-2013	Blood Sciences Ninewells Hospital & Medical School DD1 9SY Dundee United Kingdom Tel.: +44-1382-632512 Fax: +44-1382-645333 Mobile: +44-777-4103338 E-Mail E-Mail
Wytze Oosterhuis second term 2011-2013	Dept Clinical Chemistra Atrium Medical Center Henri Dunantstraat 5 6419 PC Heerlen The Netherlands Tel.: +31-455766341 Fax: +31-455676575 Mobile:+31-625065465 E-Mail
Andrea R. Horváth first term 2010-2012	SEALS North Department of Clinical Chemistry Prince of Wales Hospital Barker Street Randwick, NSW 2031 Sydney Australia Tel.: +61-2-93829078 Fax: +61-2-93829099 Mobile: +61-404027843 E-Mail
Éva Ajzner first term 2013-2014	Sz-Sz-B County’sTeaching Hospital Central Laboratory Szt Istvan Street 68 H-4400 Nyíregyháza – Hungary E-Mail: ajznereva@josa.hu

The terms of reference

The Scientific Committee is responsible for scientific matters within EFLM and projects which further the scientific development of EFLM (except those specifically related to quality management, which are the responsibility of the Quality Management Committee). Activities of the Committee should particularly focus on promotion of research that translates the scientific results of clinical chemistry and laboratory medicine to clinical applications and improves patient outcomes through the appropriate use and interpretation of laboratory data in clinical practice.

The Scientific Committee will work towards the following general goals of EFLM:

• To promote and improve science and education within the field of clinical chemistry and laboratory medicine.
• To improve patient outcomes and the quality and safety of patient care through the highest standards of laboratory medicine.

The Scientific Committee will deliver the following specific objectives of EFLM:

• Promoting scientific co-operation in clinical chemistry and laboratory medicine between European institutions and other organizations within and outside Europe.
• Co-operation in defining European guidelines for the investigation and laboratory management of diseases.
• Harmonising standards of practice in scientific matters through production of guidance documents stating best practice in areas of clinical chemistry and laboratory medicine.
• Developing European initiatives on the standardization of laboratory data.

To achieve the above, the Committee may consider pre-analytical, analytical and post-analytical matters within its remit, and will also advise on the exploitation of basic research, evaluation of new biomarkers and their translation into routine clinical practice. The Scientific Committee will have direct links to the Scientific Division of IFCC, and will also seek to maintain an overview of scientific projects being undertaken in National Societies.

The Scientific Committee will collaborate with relevant clinical and scientific societies, and will also take part in international collaborative projects involving EFLM member societies.

The Scientific Committee will organize and participate in international clinical audit projects and surveys, and will also engage in guideline development in co-operation with relevant clinical organizations.

Results of the Committee’s work will be actively disseminated at conferences and workshops, published in scientific journals (e.g. CCLM) and available on the EFLM web site. Dissemination will be carried out in co-operation with the Education and Training Committee, within the limits of available resources.

Name	Contact
Chair Mario Pazzagli first term 2013-2014	Department of Clinical Physiopathology University of Florence, ITALY E-Mail: m.pazzagli@dfc.unifi.it
Member Ivan Brandslund first term 2013-2014	Department of Clinical Biochemistry Vejle Hospital, DENMARK E-Mail: ivan.brandslund@slb.regionsyddanmark.dk
Member Pieter Vermeersch first term 2013-2014	Laboratory Medicine University Hospitals Leuven, BELGIUM E-Mail: pieter.vermeersch@uzleuven.be

Terms of reference
To define the role and responsibilities of medical laboratories in procedures linked to personalized medicine approaches in cancer. This could be achieved by developing scientific publications or guidance on:
– the recent improvements in analytical techniques (mainly genomics), linked to the rapidly increasing knowledge on biological mechanisms;
– the improvements and requirements in the corresponding computing resources;
– specific oncological pathologies describing the process of the use of co-dependent technologies (including laboratory tests) for the management of individual patients;
– the potentials and limitations of the most recent laboratory technologies applied in personalized medicine;
– setting competency standards for staff involved in testing; or
– specifying professional criteria for quality goals and for accreditation in this field.

Name	Contact
ad Interim Chair Ian Watson 2013	Department Clinical Biochemistry University Hospital Aintree Longmoor Lane L9 7AL Liverpool United Kingdom Tel.: +44 151 529 3575 Fax: +44 151 529 3310 E-Mail
Member Joel Corberand first term 2013-2014	Haematology Department Rangueil Hospital 1 Avenue Jean Poulhès Toulouse France E-Mail: corberand.j@chu-toulouse.fr
Member Per Jørgensen one year term 2013	Glostrup Hospital Ndr. Ringvej 57 2600 Glostrup Denmark E-Mail: per.joergensen.01@regionh.dk
Member Wytze Oosterhuis first term 2013-2014	Dept Clinical Chemistry Atrium Medisch Centrum Henri Dunantstraat 5 6419 PC Heerlen The Netherlands E-Mail: w.oosterhuis@atriummc.nl
Member Young Scientist Joanna Pollak first term 2013-2014	Dept of Laboratory Medicine University of Nicolaus Copernicus Collegium Medicum M. Sklodowskiej – Curie 9 85-094 Bydgoszcz Poland E-Mail: asiapollak@wp.pl
Corresponding Member Z. Gunnur Dikmen first term 2013-2014	Dept of Biochemistry University of Hacettepe 06100 Ankara Turkey E-Mail: zgunnur@gmail.com
Corresponding Member Snezana Jovicic first term 2013-2014	Center for Medical Biochemistry Clinical Center of Serbia Visegradska 26 11000 Belgrade Serbia E-Mail: hionati@gmail.com

Terms of reference

1. Evaluate and study methods for how specialists in laboratory medicine can communicate directly with the patients;
2. Evaluate and study how the laboratory can play an active role in patients using self-monitoring for monitoring their disease.

Action Plan 2013

1. Carry out a survey among European countries to evaluate what (if any) activity the EFLM member states have in the two areas above;
2. Perform a study to evaluate the usefulness of a direct report of laboratory data to the patient.

Aim

To perform a European survey on what critical result management procedures and policies laboratories have and how critical values are established and used in European laboratories.

Deliverables

To publish at least one scientific paper about the subject and to give a presentation or poster at EuroMedLab or other EFLM and/or AACB-related conference or symposium.

Members

SPIDIA
EUmetaLAB

SPIDIA

The Spidia Project‘s main aim is the development of standards for patient sample processing in order to facilitate the discovery and prediction of diseases.

EFLM will participate in the SPIDIA Project supporting the process of standardization and of the dissemination of the results.

Background

The European Union has launched a new research project targeting to expand the potentials and utility of in-vitro diagnostics through the creation of new standards for the collection, handling and processing of blood, tissue, tumor and other sample materials. Under the 7th Framework Programme, the European Commission approved the initiative’s funding and scope to develop corresponding standards, tools and quality assurance schemes. The SPIDIA project (“Standardization and improvement of generic Pre-analytical tools and procedures for In-vitro Diagnostics”) is scheduled to run for four years and has a total budget of over 13 million Euros. The consortium, consisting of a total of 16 companies and research institutions from 11 countries, will be led by QIAGEN, Europe’s largest biotechnology company and a global leader in molecular sample and assay technologies.

The project has been set up to standardize the pre-analytical handling of patient samples used for in-vitro diagnosis of human diseases. The EU Commission has recognized that in “in-vitro” diagnostics, the collection, handling and processing of sample materials are regarded as particularly critical procedures, as the reliability of the subsequent analysis and therefore the meaningfulness of the diagnosis are vitally dependent upon the integrity of the sample.

This seems particularly relevant for the so-called “Molecular Diagnostics”, in which DNA, RNA or proteomic analysis will play a particularly vital role in future healthcare in Europe. It is believed that these new diagnostics should allow earlier and more reliable information about the status of a disease than conventional methods. Molecular diagnostics can also facilitate predictions concerning the future courses of diseases and lead to individualized therapeutic measures. They are therefore viewed as fundamental to the emergence of the new era of personalized medicine.

EFLM and SPIDIA

EFLM welcomes the SPIDIA initiative and it is interested in playing a role in the project for a significant expansion of the potential of in-vitro diagnostics and in particular in supporting the process of the standardization of the collection, handling and processing of biological samples and in the dissemination of the results of this project. With its support of this project, the EFLM is providing strong leadership in emphasizing the importance of these processes in general and molecular diagnostics and their role as cornerstones of future healthcare in Europe. Specific activities of EFLM in supporting the SPIDIA Project will be soon described in this web site.

About SPIDIA

The SPIDIA project (Standardization and improvement of generic Pre-analytical tools and procedures for In-vitro Diagnostics) is a Consortium of 16 members from 11 countries, including companies such as TATAA BIOCENTER AB, PreAnalytiX GmbH (a QIAGEN/BD Company), DIAGENIC ASA, Aros Applied Biotechnology A/S, Dako Denmark A/S, ACIES, ImmunID Technologies, academic partners such as universities and research institutes in Munich, Florence, Graz, Prague and Rotterdam. The International Agency for Research and Cancer and the European Standardization Committee are also members of the project, which is being led by QIAGEN GmbH in Hilden. EFLM role in the SPIDIA Project is recognized with a subcontracting for specific activities addressing topics on Standardization and Dissemination. The project is being sponsored as part of the European Union’s 7th framework programme.

EUmetaLAB

EU-wide interdisciplinary Metastructure for the Generation and Support of multicentric clinical Research Studies

The background problem

Biotechnology is considered the most important new areas of technology for the 21st century and already has gained profound impact on life sciences and medicine. In order to identify disease mechanisms, devise new therapeutic strategies and provide health benefit for the individual patient citizen, modern medicine increasingly uses advanced high-throughput technologies that have emerged over the last 20 years. To employ these technologies, archived samples from biomaterial resources have become an important source for translational and clinical research studies, and numerous biobanks have been established over the last years. A Europe-wide biobanking network is a logical concept possessing high potential to foster European research and eventually improve health care. However, major challenges include harmonization and standardization of future biomaterial archives for later translational research and scientific clinical studies – a challenge by far not met at present.

Indeed, harmonization of existing biobank is a very difficult task due to highly specialized laboratory data and medical context data sets (e.g. when collected in different context like arteriosclerosis or cancer or when designed with different perspectives). Accordingly, the overlapping information generated from these biobanks may be limit mutual use. With respect to the development of future biobanking projects on supranational scale, biobanking partners will need rigorous standardization of sampling, processing and archiving. Again, consented standards are far from being defined. Another issue is the time needed to develop biobanking networks (each then still representing research projects dedicated to single or few disease entities) to grow to representative sizes suitable for large studies. Finally, bioanalytes behave differently under archiving conditions. For example, while DNA is “basically indestructible” in a biosample, instable biomarkers like RNA, proteins, metabolites or whole cells are very delicate.

The EUmetaLAB project

EUmetaLAB represents an ambitious concept to support scientific Laboratory Medicine, multicentric scientific studies and assist biobanking initiatives. EUmetaLAB is embedded in the European Society for Clinical Chemistry (EFLM). The project will aim at the standardization in management and processing of routine clinical biosamples (mainly serum and plasma) received by Clinical Chemistry laboratories. Clinical Chemistry and Laboratory Medicine are central to public health care throughout Europe, as they provide clinicians with critical medical information. Clinical laboratories process by far the largest numbers of blood samples every day.
EUmetaLAB´s presumption is that within clinical labs the sample handling, monitoring and archiving already has reached a high level of standardization, thus allowing the definition of comparable routine procedures that result in biosamples of homogeneous qualities. In addition, modern clinical laboratories use comparable analytical methods and machinery allowing to assess and to compare sample qualities. Finally, most laboratories run extensive quality management systems ranging from internal control to participation in external quality assessment and to accreditation allowing to constantly monitor their analytical and professional proficiency.

EUmetaLAB aims at networking European academic clinical laboratories to provide the backbone for future multicentric biomaterial sampling (a laboratory metastructure) in a standardized manner. In contrast to the local disease-oriented biobanking, EUmetaLAB is highly dynamic, adjustable to changes and responsive to scientific requests for biomaterial on a multicentric scale. Of advantage is the high-throughput sample flow covering all diseases and disease states observable in Europe.

The backbone of EUmetaLAB is the „NetPoint“ consisting of laboratory and the clinical unit sending diagnostic samples (Fig.1). Clinical units provide medical context data with the samples. EUmetaLAB samples consists of three components that can be delivered for scientific studies: the pseudonymized sample in standardized quality, the lab data set containing routine clinical laboratory test results and a basic medical context data set including medical information on condition together environmental information for stratification. The sets are consented between NetPoints and follow standardize EUmetaLAB procedures and internal quality guidelines.

Fig. 1: Harmonization of laboratory and clinical aspects in an individual NETpoint (vertical harmonization) and between all NETpoints (horizontal harmonizations) as proposed by EUmetaLAB

The EUmetaLAB procedures ensure that samples with equal quality can be provided from the different NetPoints in Europe (e.g. in Helsinki and Lisboa). SOPs exist or will be established for rapid adjustments of these sets related to requests by the studies. Existing External Quality Assessment (EQA) schemes will be used to ensure comparability of laboratory routine test results from different NetPoints. In addition, novel EQA programs will be implemented to monitor specific EUmetaLAB activities for quality verification and harmonization. An IT framework will be needed and implemented in EUmetaLAB for communication within the network. EUmetaLAB server and website will be implemented to provide all information required to schedule its cooperation with studies and other biomaterial resources.

Members

Name	Contact
Chair Andrea R. Horváth second term 2013-2014	SEALS North, Department of Clinical Chemistry Prince of Wales Hospital Barker Street Randwick, NSW 2031 Sydney – Australia Tel.: +61-2-93829078 Fax: +61-2-93829099 Mobile: +61-404027843 E-Mail: rita.horvath@sesiahs.health.nsw.gov.au
Member Christa Cobbaert second term 2013-2014	Dept of Clinical Chemistry Leiden University Medical Center Albinusdreef 2 NL 2300 RC Leiden – The Nederland Tel.: +31-71-5264483 Tel.: +31-71-5266753 E-Mail: c.m.cobbaert@lumc.nl
Member Andrew St. John first term 2012-2014	Perth Australia E-Mail: astjohn14@gmail.com
Member Sally Lord first term 2013-2014	NHM RC Clinical Trials Centre The University of Sidney – Autralia Tel.: +61-2-95625322, Fax: +61-2-95651863 E-Mail: sally.lord@ctc.usyd.edu.au
Member Young Scientist Dr Phillip J Monaghan first term 2012-2014	Department of Clinical Biochemistry The Christie Hospital NHS Foundation Trust Wilmslow Road Withington, Manchester, M 20 4BX, UK Tel.: 0044-161-446 3298 E-Mail: phillip.monaghan@nhs.net
Corresponding Member Alexey Bugrov first term 2012-2014	Dept. of Clinical Laboratory Diagnostics Russian Medical Academy of Postgraduate Education 125424 P.O.B. Moscow 32, Russia Tel.: 0079-265769490 Fax: 0074-959458400 E-Mail: avb81@bk.ru
Expert/Consultant Sverre Sandberg	Laboratory of Clinical Biochemistry Haukeland University Hospital NO 5021 Bergen – Norway E-Mail: sverre.sandberg@isf.uib.no
Expert/Consultant Patrick Bossuyt	Amsterdam – The Netherlands E-Mail: p.m.bossuyt@amc.nl
Expert/Consultant Lieselotte Lennartz	Scientific Affairs Manager EMEA (Europe, Middle East, Africa & India ) Abbott GmbH & Co.KG Max-Planck-Ring 2 65205 Wiesbaden – Germany Tel.: +49(0)6122 58-2886 Fax: +49(0)6122 58-1668 Mobile: +49(0)151 14038965 E-Mail: l.lennartz@abbott.com
Expert/Consultant Wilma Verhagen-Kamerbeek	Clinical Science Leader Roche Diagnostics Ltd. Roche Professional Diagnostics DXC Medical Affairs, Forrenstraße 6343 Rotkreuz – Switzerland Tel.: +41(0)41 798 78 28 Fax: +41(0)41 798 72 29 E-Mail: wilma_dj.verhagen-kamerbeek@roche.com
Expert/Consultant Christoph Ebert	Head of Clinical Trials Roche Diagnostics Ltd. Roche Professional Diagnostics DXC Medical Affairs,Forrenstraße 6343 Rotkreuz – Switzerland Tel.: +41(0)41 798 78 28 Fax: +41(0)41 798 72 29 E-Mail: christoph.ebert@roche.com

EFLM Science Committee, Chair: Prof. Sverre Sandberg
Test Evaluation Working Group (WG-TE),

Chair: Prof. Andrea Rita Horvath
Email: rita.horvath@sesiahs.health.nsw.gov.au

EFLM’s Test Evaluation Working Group (WG-TE), established under its Science Committee, is a joint collaboration between EFLM and AACB (Australasian Association of Clinical Biochemistry). Membership of this WG represents collaboration between experts in evidence-based laboratory medicine, evidence-based diagnosis and epidemiology, and research and development of IVD industrial partners. The background, rationale and terms of reference of the working group are listed below.

Background and rationale

Clinical utilization and reimbursement for laboratory tests should move from a cost-based towards a value- and evidence-based approach. Laboratory tests have clinical value only if they provide benefit to patients at acceptable costs. Translational research aims to decrease the gap between the identification of new biomarkers and proving that these are clinically effective and improve patient-centred, organizational or economic outcomes. Nevertheless, new laboratory tests are often released to market with little evidence supporting their value or impact in clinical practice. Since resources are finite, evidence-based decisions about the use of diagnostic interventions should depend on well-designed and conducted test evaluation studies and technology appraisals.

After initial discovery of new biomarkers, careful consideration should be given to its purpose, the context and the clinical pathway for its application, the population and healthcare setting in which the test is intended to be used, and its potential consequences in clinical practice. No new test should be subjected to tedious evaluation if the test is unlikely to result in improved clinical actions or measurable outcomes. Test evaluation should be carried out with carefully planned study designs appropriate for the questions addressed at each stage of development. The below steps are proposed when investigating the value of testing: Basic research into the association of disease with the new biomarker; Research into the analytical and clinical performance of tests; Clinical research into the clinical application and effectiveness of tests; Impact of testing in practice.

The evidence-based methodology of these steps is not widely understood and there are now a number of published examples on the common pitfalls and potential biases in test evaluation studies that may lead to inappropriate medical decisions and threaten patient safety. Therefore the European Commission and IVD regulatory bodies have also acknowledged that a more responsive and proportionate risk assessment during pre-market approval of new tests is needed, which involves the review of the evidence for the clinical effectiveness and impact of new biomarkers.

Terms of reference:

1. To develop a framework and guidance for the appropriate evaluation of the clinical effectiveness and impact of new laboratory tests.
2. To develop practical toolboxes which support the design and conduct of clinical research trials for the above purposes.
3. Education and training of researchers via pilot biomarker studies on how to design test evaluation studies.
4. Collaboration with epidemiologists, industry and regulatory authorities in setting standards for clinical evaluation of new biomarkers.

Deliverables:

General guidance on the process of test evaluation studies and on the best study design for the clinical evaluation of new tests at various stages of the test development process.

Criteria for test evaluation studies depending on the purpose or intended clinical application of the new test (i.e. diagnosis, screening, monitoring, risk assessment, prognosis).

Minimum reporting criteria that can also be used by regulatory or approval bodies (e.g. FDA, CE marking) assessing the clinical value of new biomarkers.
Training materials and courses on diagnostic trial design and how to conduct high quality diagnostic studies.

Representation of EFLM’s above interests at relevant international forums and commenting the revision of the EU IVD Directive at EC level accordingly. (The latter will be carried out in collaboration with EFLM’s delegates to the EC Exploratory Process on Medical Devices and jointly with EFLM’s WG-IVD).

Members

Name	Contact
Chair Ana-Maria Simundic first term 2012-2014	University Dept. of Chemistry University Hospital “Sestre Milosrdnice” Vinogradska 29 10000 Zagreb, Croatia Tel.: +385-1-3787184 Fax: +385-1-3768280 Mobile: +385-99-2554708 E-Mail: am.simundic@gmail.com
Member Giuseppe Lippi first term 2012-2014	Clinical Chemistry and Hematology Laboratory Academic Hospital of Parma, Italy E-Mail: glippi@ao.pr.it
Member Kjell Grankvist first term 2012-2014	Dept. of Medical Biosciences, Clinical Chemistry Umea University Building 6M 2nd Floor S-90185 Umea – Sweden Tel.: +46-907851262, Fax: +46-907854484 E-Mail: kjell.grankvist@medbio.umu.se
Member Mads Nybo first term 2012-2014	Dept. of Clinical Biochemistry and Pharmacology Odense University Hospital Sdr. Boulevard 29 5000 Odense C – Denmark Tel.: +45-65411161 E-Mail: mads.nybo@ouh.regionsyddanmark.dk
Member Young Scientist Michael Cornes first term 2012-2014	The Royal Wolverhampton Hospitals NHS Trust New Cross Hospital Wednessfield Road Wloverhampton WV10 0QP – UK Tel.: +45-65411161 E-Mail: michael.cornes@nhs.net
Corresponding Member Pinar Eker first term 2013-2014	Umraniye Training And Research Hospital Istanbul, Turkey E-Mail: pinareker@yahoo.com
Corresponding Member Svetlana Kovalevskaya first term 2012-2014	Labstory Company Office 312 Saint Petersburg, Russia E-Mail: kovalevskaya@labstory.ru
Corresponding Member Gunn B.B. Kristensen first term 2012-2014	NKK– Norwegian Clinical Chemistry EQA Programme Bergen, Norway E-Mail: gunn.kristensen@noklus.no
Corresponding Member Ludek Sprongl first term 2012-2014	Central Laboratory Sumperska nemocnice a.s. Sumperk, Czech Rep. E-Mail: sprongl@nemspk.cz
Corresponding Member Zorica Sumarac first term 2012-2014	Center for Medical Biochemistry Clinical Center of Serbia Belgrade, Serbia E-Mail: zsumarac@open.telekom.rs
Corresponding Member Edmée van Dongen-Lases first term 2013-2014	Dept. of Clinical Chemistry Academic Medical Center Amsterdam, The Netherlands E-Mail: e.c.vanDongen-Lases@amc.nl
Expert/Consultant Stephen Church	Becton Diskinson E-Mail: stephen_church@europe.bd.com

Members

Members

Name	Contact
Chair WG-G Wytze Oosterhuis second term 2011-2013	Dept Clinical Chemistry Atrium Medisch Centrum Henri Dunantstraat 5 6419 PC Heerlen – The Netherlands Tel.: +31-455766341 Fax: +31-455676575 E-Mail: w.oosterhuis@atriummc.nl
Member Kristin Moberg Aakre second term 2011-2013	Laboratory of Clinical Biochemistry Haukeland University Hospital Jonas Lies vei 65 5021 Bergen – Norway Tel.: +47 55973155 E-Mail: kristin.moberg.aakre@helse-bergen.no
Member Joseph Watine second term 2011-2013	Biologie Polyvalente Hopital de la Chartreuse Avenue Caylet 12200 Villefranche-de-Rouergue, France Tel.: +33-565653131 Fax: +33-565653112 E-Mail: wjoseph61@hotmail.com
Member Julian H. Barth first term 2011-2013	c/o ACB 130-132 Tooley St London SE1 2TU, UK Tel.: +44-20-74038001 Fax: +44-20-74038006 E-Mail: Julian.Barth@leedsth.nhs.uk
Member Michel R. Langlois first term 2011-2013	Dept. of Laboratory Medicine AZ St. Jan Hospital Ruddershove 10, B-8000 Bruges, Beldium E-Mail: michel.langlois@azsintjan.be
Member Young Scientist Shivani Misra first term 2012-2014	Clinical Biochemistry 8th Floor East Wing Charing Cross Hospital Fullham Palace Road London, W6 8RF, UK E-Mail: s.misra@imperial.ac.uk
Expert/Consultant Ferruccio Ceriotti	Diagnostica e Ricerca San Raffaele S.p.A Via Olgettina 60 20132 Milano – Italy Tel.: +39-02-26432282 Fax: +39-02-26432640 E-Mail: sceriotti.ferruccio@hsr.it

Terms of reference

Co-operation in defining European guidelines for the investigation and laboratory management of disease by:

1. Prepare guidelines for making recommendations for laboratory testing
2. Co-operate with clinical guidelines developers (e.g. SIGN, ADA, NICE) for the development of the laboratory part of clinical guidelines
3. Develop laboratory guidelines for reflective testing

Members

Name	Contact
Chair Päivi Laitinen first term 2011-2013	HUSLAB Clinical Chemistry and Haematology P.O. Box 340 00290 Helsinki Haartmaninkatu 4 Tel: +358 50 427 9208 E-Mail: paivi.h.laitinen@hus.fi
Member Paul Collinson first term 2011-2013	St George’s Hospital Blackshaw Road SW17 0QT London United Kingdom Tel: +44-208-725-5934 E-Mail: paul.collinson@stgeorges.nhs.uk
Member Marja P. van Dieijen-Visser first term 2011-2013	Netherlands E-Mail: mp.van.dieijen.visser@mumc.nl
Member Angelika Hammerer-Lercher first term 2011-2013	Austria E-Mail: angelika.hammerer-lercher@uki.at
Member Kari Pulkki first term 2011-2013	Dept of Clinical Chemistry (Laboratory Medicine) School of Medicine, Univ. of Eastern Finland Kuopio Eastern Finland Laboratory Centre Joint Authority Enterprise, P.O. Box 1700 FIN-70211 Finland E-Mail: kari.pulkki@uef.fi E-Mail: kari.pulkki@islab.fi
Member Young Scientist Christopher Duff first term 2012-2014	Department of Biochemistry University Hospital of North Staffordshire Stoke-on-Trent, ST4 7PX – UK Tel: +44-1782-555195 E-Mail: chris.duff@uhns.nhs.uk
Corresponding Member Ana Stavljenic-Rukavena first term 2011-2013	Hungary E-Mail: ana.stavljenic-rukavina@zg.htnet.hr
Corresponding Member Michel Langlois first term 2011-2013	Belgium
Corresponding Member Kristin Moberg Aakre first term 2011-2013	Laboratory of Clinical Biochemistry Haukeland University Hospital Jonas Lies vei 65 5020 Bergen Norway Tel: +47 55973188 Fax: +47 55975976 E-Mail: kristin.moberg.aakre@helse-bergen.no
Corresponding Member Hannsjörg Baum first term 2012-2014	Klinikum Ludwigsburg Posilipostraße 4 571640 Ludwigsburg Germany Tel: +49 7141-9965800 Fax: +49-7141-9965819 E-Mail: hannsjoerg.baum@verbund-rkh.de: hannsjoerg.baum@verbund-rkh.de

Members
The terms of reference

The members of the Scientific Committee are the chairs of the different working groups whereas the chair of the SC is directly appointed by the Executive Board.

Members

Name	Contact
Chair Sverre Sandberg second term 2011-2013	Laboratory of Clinical Chemistry Haukeland University Hospital N-5021 Bergen Norway E-Mail
Päivi Laitinen first term 2011-2013	HUSLAB Clinical Chemistry and Haematology P.O. Box 340 00290 Helsinki Haartmaninkatu 4 Phone:+358 50 427 9208 E-Mail
Ana-Maria Simundić first term 2011-2013	University Dept. of Chemistry University Hospital “Sestre Milosrdnice” Vinogradska 29 10000 Zagreb Croatia Tel.: +385-1-3787184 Fax: +385-1-3768280 Mobile: +385-99-2554708 E-Mail
William A. Bartlett second term 2011-2013	Blood Sciences Ninewells Hospital & Medical School DD1 9SY Dundee United Kingdom Tel.: +44-1382-632512 Fax: +44-1382-645333 Mobile: +44-777-4103338 E-Mail E-Mail
Wytze Oosterhuis second term 2011-2013	Dept Clinical Chemistra Atrium Medical Center Henri Dunantstraat 5 6419 PC Heerlen The Netherlands Tel.: +31-455766341 Fax: +31-455676575 Mobile:+31-625065465 E-Mail
Andrea R. Horváth first term 2010-2012	SEALS North Department of Clinical Chemistry Prince of Wales Hospital Barker Street Randwick, NSW 2031 Sydney Australia Tel.: +61-2-93829078 Fax: +61-2-93829099 Mobile: +61-404027843 E-Mail
Éva Ajzner first term 2013-2014	Sz-Sz-B County’sTeaching Hospital Central Laboratory Szt Istvan Street 68 H-4400 Nyíregyháza – Hungary E-Mail: ajznereva@josa.hu

The terms of reference

The Scientific Committee is responsible for scientific matters within EFLM and projects which further the scientific development of EFLM (except those specifically related to quality management, which are the responsibility of the Quality Management Committee). Activities of the Committee should particularly focus on promotion of research that translates the scientific results of clinical chemistry and laboratory medicine to clinical applications and improves patient outcomes through the appropriate use and interpretation of laboratory data in clinical practice.

The Scientific Committee will work towards the following general goals of EFLM:

• To promote and improve science and education within the field of clinical chemistry and laboratory medicine.
• To improve patient outcomes and the quality and safety of patient care through the highest standards of laboratory medicine.

The Scientific Committee will deliver the following specific objectives of EFLM:

• Promoting scientific co-operation in clinical chemistry and laboratory medicine between European institutions and other organizations within and outside Europe.
• Co-operation in defining European guidelines for the investigation and laboratory management of diseases.
• Harmonising standards of practice in scientific matters through production of guidance documents stating best practice in areas of clinical chemistry and laboratory medicine.
• Developing European initiatives on the standardization of laboratory data.

To achieve the above, the Committee may consider pre-analytical, analytical and post-analytical matters within its remit, and will also advise on the exploitation of basic research, evaluation of new biomarkers and their translation into routine clinical practice. The Scientific Committee will have direct links to the Scientific Division of IFCC, and will also seek to maintain an overview of scientific projects being undertaken in National Societies.

The Scientific Committee will collaborate with relevant clinical and scientific societies, and will also take part in international collaborative projects involving EFLM member societies.

The Scientific Committee will organize and participate in international clinical audit projects and surveys, and will also engage in guideline development in co-operation with relevant clinical organizations.

Results of the Committee’s work will be actively disseminated at conferences and workshops, published in scientific journals (e.g. CCLM) and available on the EFLM web site. Dissemination will be carried out in co-operation with the Education and Training Committee, within the limits of available resources.

Name	Contact
Chair Mario Pazzagli first term 2013-2014	Department of Clinical Physiopathology University of Florence, ITALY E-Mail: m.pazzagli@dfc.unifi.it
Member Ivan Brandslund first term 2013-2014	Department of Clinical Biochemistry Vejle Hospital, DENMARK E-Mail: ivan.brandslund@slb.regionsyddanmark.dk
Member Pieter Vermeersch first term 2013-2014	Laboratory Medicine University Hospitals Leuven, BELGIUM E-Mail: pieter.vermeersch@uzleuven.be

Terms of reference
To define the role and responsibilities of medical laboratories in procedures linked to personalized medicine approaches in cancer. This could be achieved by developing scientific publications or guidance on:
– the recent improvements in analytical techniques (mainly genomics), linked to the rapidly increasing knowledge on biological mechanisms;
– the improvements and requirements in the corresponding computing resources;
– specific oncological pathologies describing the process of the use of co-dependent technologies (including laboratory tests) for the management of individual patients;
– the potentials and limitations of the most recent laboratory technologies applied in personalized medicine;
– setting competency standards for staff involved in testing; or
– specifying professional criteria for quality goals and for accreditation in this field.

Name	Contact
ad Interim Chair Ian Watson 2013	Department Clinical Biochemistry University Hospital Aintree Longmoor Lane L9 7AL Liverpool United Kingdom Tel.: +44 151 529 3575 Fax: +44 151 529 3310 E-Mail
Member Joel Corberand first term 2013-2014	Haematology Department Rangueil Hospital 1 Avenue Jean Poulhès Toulouse France E-Mail: corberand.j@chu-toulouse.fr
Member Per Jørgensen one year term 2013	Glostrup Hospital Ndr. Ringvej 57 2600 Glostrup Denmark E-Mail: per.joergensen.01@regionh.dk
Member Wytze Oosterhuis first term 2013-2014	Dept Clinical Chemistry Atrium Medisch Centrum Henri Dunantstraat 5 6419 PC Heerlen The Netherlands E-Mail: w.oosterhuis@atriummc.nl
Member Young Scientist Joanna Pollak first term 2013-2014	Dept of Laboratory Medicine University of Nicolaus Copernicus Collegium Medicum M. Sklodowskiej – Curie 9 85-094 Bydgoszcz Poland E-Mail: asiapollak@wp.pl
Corresponding Member Z. Gunnur Dikmen first term 2013-2014	Dept of Biochemistry University of Hacettepe 06100 Ankara Turkey E-Mail: zgunnur@gmail.com
Corresponding Member Snezana Jovicic first term 2013-2014	Center for Medical Biochemistry Clinical Center of Serbia Visegradska 26 11000 Belgrade Serbia E-Mail: hionati@gmail.com

Terms of reference

1. Evaluate and study methods for how specialists in laboratory medicine can communicate directly with the patients;
2. Evaluate and study how the laboratory can play an active role in patients using self-monitoring for monitoring their disease.

Action Plan 2013

1. Carry out a survey among European countries to evaluate what (if any) activity the EFLM member states have in the two areas above;
2. Perform a study to evaluate the usefulness of a direct report of laboratory data to the patient.

Aim

To perform a European survey on what critical result management procedures and policies laboratories have and how critical values are established and used in European laboratories.

Deliverables

To publish at least one scientific paper about the subject and to give a presentation or poster at EuroMedLab or other EFLM and/or AACB-related conference or symposium.

Members

SPIDIA
EUmetaLAB

SPIDIA

The Spidia Project‘s main aim is the development of standards for patient sample processing in order to facilitate the discovery and prediction of diseases.

EFLM will participate in the SPIDIA Project supporting the process of standardization and of the dissemination of the results.

Background

The European Union has launched a new research project targeting to expand the potentials and utility of in-vitro diagnostics through the creation of new standards for the collection, handling and processing of blood, tissue, tumor and other sample materials. Under the 7th Framework Programme, the European Commission approved the initiative’s funding and scope to develop corresponding standards, tools and quality assurance schemes. The SPIDIA project (“Standardization and improvement of generic Pre-analytical tools and procedures for In-vitro Diagnostics”) is scheduled to run for four years and has a total budget of over 13 million Euros. The consortium, consisting of a total of 16 companies and research institutions from 11 countries, will be led by QIAGEN, Europe’s largest biotechnology company and a global leader in molecular sample and assay technologies.

The project has been set up to standardize the pre-analytical handling of patient samples used for in-vitro diagnosis of human diseases. The EU Commission has recognized that in “in-vitro” diagnostics, the collection, handling and processing of sample materials are regarded as particularly critical procedures, as the reliability of the subsequent analysis and therefore the meaningfulness of the diagnosis are vitally dependent upon the integrity of the sample.

This seems particularly relevant for the so-called “Molecular Diagnostics”, in which DNA, RNA or proteomic analysis will play a particularly vital role in future healthcare in Europe. It is believed that these new diagnostics should allow earlier and more reliable information about the status of a disease than conventional methods. Molecular diagnostics can also facilitate predictions concerning the future courses of diseases and lead to individualized therapeutic measures. They are therefore viewed as fundamental to the emergence of the new era of personalized medicine.

EFLM and SPIDIA

EFLM welcomes the SPIDIA initiative and it is interested in playing a role in the project for a significant expansion of the potential of in-vitro diagnostics and in particular in supporting the process of the standardization of the collection, handling and processing of biological samples and in the dissemination of the results of this project. With its support of this project, the EFLM is providing strong leadership in emphasizing the importance of these processes in general and molecular diagnostics and their role as cornerstones of future healthcare in Europe. Specific activities of EFLM in supporting the SPIDIA Project will be soon described in this web site.

About SPIDIA

The SPIDIA project (Standardization and improvement of generic Pre-analytical tools and procedures for In-vitro Diagnostics) is a Consortium of 16 members from 11 countries, including companies such as TATAA BIOCENTER AB, PreAnalytiX GmbH (a QIAGEN/BD Company), DIAGENIC ASA, Aros Applied Biotechnology A/S, Dako Denmark A/S, ACIES, ImmunID Technologies, academic partners such as universities and research institutes in Munich, Florence, Graz, Prague and Rotterdam. The International Agency for Research and Cancer and the European Standardization Committee are also members of the project, which is being led by QIAGEN GmbH in Hilden. EFLM role in the SPIDIA Project is recognized with a subcontracting for specific activities addressing topics on Standardization and Dissemination. The project is being sponsored as part of the European Union’s 7th framework programme.

EUmetaLAB

EU-wide interdisciplinary Metastructure for the Generation and Support of multicentric clinical Research Studies

The background problem

Biotechnology is considered the most important new areas of technology for the 21st century and already has gained profound impact on life sciences and medicine. In order to identify disease mechanisms, devise new therapeutic strategies and provide health benefit for the individual patient citizen, modern medicine increasingly uses advanced high-throughput technologies that have emerged over the last 20 years. To employ these technologies, archived samples from biomaterial resources have become an important source for translational and clinical research studies, and numerous biobanks have been established over the last years. A Europe-wide biobanking network is a logical concept possessing high potential to foster European research and eventually improve health care. However, major challenges include harmonization and standardization of future biomaterial archives for later translational research and scientific clinical studies – a challenge by far not met at present.

Indeed, harmonization of existing biobank is a very difficult task due to highly specialized laboratory data and medical context data sets (e.g. when collected in different context like arteriosclerosis or cancer or when designed with different perspectives). Accordingly, the overlapping information generated from these biobanks may be limit mutual use. With respect to the development of future biobanking projects on supranational scale, biobanking partners will need rigorous standardization of sampling, processing and archiving. Again, consented standards are far from being defined. Another issue is the time needed to develop biobanking networks (each then still representing research projects dedicated to single or few disease entities) to grow to representative sizes suitable for large studies. Finally, bioanalytes behave differently under archiving conditions. For example, while DNA is “basically indestructible” in a biosample, instable biomarkers like RNA, proteins, metabolites or whole cells are very delicate.

The EUmetaLAB project

EUmetaLAB represents an ambitious concept to support scientific Laboratory Medicine, multicentric scientific studies and assist biobanking initiatives. EUmetaLAB is embedded in the European Society for Clinical Chemistry (EFLM). The project will aim at the standardization in management and processing of routine clinical biosamples (mainly serum and plasma) received by Clinical Chemistry laboratories. Clinical Chemistry and Laboratory Medicine are central to public health care throughout Europe, as they provide clinicians with critical medical information. Clinical laboratories process by far the largest numbers of blood samples every day.
EUmetaLAB´s presumption is that within clinical labs the sample handling, monitoring and archiving already has reached a high level of standardization, thus allowing the definition of comparable routine procedures that result in biosamples of homogeneous qualities. In addition, modern clinical laboratories use comparable analytical methods and machinery allowing to assess and to compare sample qualities. Finally, most laboratories run extensive quality management systems ranging from internal control to participation in external quality assessment and to accreditation allowing to constantly monitor their analytical and professional proficiency.

EUmetaLAB aims at networking European academic clinical laboratories to provide the backbone for future multicentric biomaterial sampling (a laboratory metastructure) in a standardized manner. In contrast to the local disease-oriented biobanking, EUmetaLAB is highly dynamic, adjustable to changes and responsive to scientific requests for biomaterial on a multicentric scale. Of advantage is the high-throughput sample flow covering all diseases and disease states observable in Europe.

The backbone of EUmetaLAB is the „NetPoint“ consisting of laboratory and the clinical unit sending diagnostic samples (Fig.1). Clinical units provide medical context data with the samples. EUmetaLAB samples consists of three components that can be delivered for scientific studies: the pseudonymized sample in standardized quality, the lab data set containing routine clinical laboratory test results and a basic medical context data set including medical information on condition together environmental information for stratification. The sets are consented between NetPoints and follow standardize EUmetaLAB procedures and internal quality guidelines.

Fig. 1: Harmonization of laboratory and clinical aspects in an individual NETpoint (vertical harmonization) and between all NETpoints (horizontal harmonizations) as proposed by EUmetaLAB

The EUmetaLAB procedures ensure that samples with equal quality can be provided from the different NetPoints in Europe (e.g. in Helsinki and Lisboa). SOPs exist or will be established for rapid adjustments of these sets related to requests by the studies. Existing External Quality Assessment (EQA) schemes will be used to ensure comparability of laboratory routine test results from different NetPoints. In addition, novel EQA programs will be implemented to monitor specific EUmetaLAB activities for quality verification and harmonization. An IT framework will be needed and implemented in EUmetaLAB for communication within the network. EUmetaLAB server and website will be implemented to provide all information required to schedule its cooperation with studies and other biomaterial resources.

Members

Name	Contact
Chair Andrea R. Horváth second term 2013-2014	SEALS North, Department of Clinical Chemistry Prince of Wales Hospital Barker Street Randwick, NSW 2031 Sydney – Australia Tel.: +61-2-93829078 Fax: +61-2-93829099 Mobile: +61-404027843 E-Mail: rita.horvath@sesiahs.health.nsw.gov.au
Member Christa Cobbaert second term 2013-2014	Dept of Clinical Chemistry Leiden University Medical Center Albinusdreef 2 NL 2300 RC Leiden – The Nederland Tel.: +31-71-5264483 Tel.: +31-71-5266753 E-Mail: c.m.cobbaert@lumc.nl
Member Andrew St. John first term 2012-2014	Perth Australia E-Mail: astjohn14@gmail.com
Member Sally Lord first term 2013-2014	NHM RC Clinical Trials Centre The University of Sidney – Autralia Tel.: +61-2-95625322, Fax: +61-2-95651863 E-Mail: sally.lord@ctc.usyd.edu.au
Member Young Scientist Dr Phillip J Monaghan first term 2012-2014	Department of Clinical Biochemistry The Christie Hospital NHS Foundation Trust Wilmslow Road Withington, Manchester, M 20 4BX, UK Tel.: 0044-161-446 3298 E-Mail: phillip.monaghan@nhs.net
Corresponding Member Alexey Bugrov first term 2012-2014	Dept. of Clinical Laboratory Diagnostics Russian Medical Academy of Postgraduate Education 125424 P.O.B. Moscow 32, Russia Tel.: 0079-265769490 Fax: 0074-959458400 E-Mail: avb81@bk.ru
Expert/Consultant Sverre Sandberg	Laboratory of Clinical Biochemistry Haukeland University Hospital NO 5021 Bergen – Norway E-Mail: sverre.sandberg@isf.uib.no
Expert/Consultant Patrick Bossuyt	Amsterdam – The Netherlands E-Mail: p.m.bossuyt@amc.nl
Expert/Consultant Lieselotte Lennartz	Scientific Affairs Manager EMEA (Europe, Middle East, Africa & India ) Abbott GmbH & Co.KG Max-Planck-Ring 2 65205 Wiesbaden – Germany Tel.: +49(0)6122 58-2886 Fax: +49(0)6122 58-1668 Mobile: +49(0)151 14038965 E-Mail: l.lennartz@abbott.com
Expert/Consultant Wilma Verhagen-Kamerbeek	Clinical Science Leader Roche Diagnostics Ltd. Roche Professional Diagnostics DXC Medical Affairs, Forrenstraße 6343 Rotkreuz – Switzerland Tel.: +41(0)41 798 78 28 Fax: +41(0)41 798 72 29 E-Mail: wilma_dj.verhagen-kamerbeek@roche.com
Expert/Consultant Christoph Ebert	Head of Clinical Trials Roche Diagnostics Ltd. Roche Professional Diagnostics DXC Medical Affairs,Forrenstraße 6343 Rotkreuz – Switzerland Tel.: +41(0)41 798 78 28 Fax: +41(0)41 798 72 29 E-Mail: christoph.ebert@roche.com

EFLM Science Committee, Chair: Prof. Sverre Sandberg
Test Evaluation Working Group (WG-TE),

Chair: Prof. Andrea Rita Horvath
Email: rita.horvath@sesiahs.health.nsw.gov.au

EFLM’s Test Evaluation Working Group (WG-TE), established under its Science Committee, is a joint collaboration between EFLM and AACB (Australasian Association of Clinical Biochemistry). Membership of this WG represents collaboration between experts in evidence-based laboratory medicine, evidence-based diagnosis and epidemiology, and research and development of IVD industrial partners. The background, rationale and terms of reference of the working group are listed below.

Background and rationale

Clinical utilization and reimbursement for laboratory tests should move from a cost-based towards a value- and evidence-based approach. Laboratory tests have clinical value only if they provide benefit to patients at acceptable costs. Translational research aims to decrease the gap between the identification of new biomarkers and proving that these are clinically effective and improve patient-centred, organizational or economic outcomes. Nevertheless, new laboratory tests are often released to market with little evidence supporting their value or impact in clinical practice. Since resources are finite, evidence-based decisions about the use of diagnostic interventions should depend on well-designed and conducted test evaluation studies and technology appraisals.

After initial discovery of new biomarkers, careful consideration should be given to its purpose, the context and the clinical pathway for its application, the population and healthcare setting in which the test is intended to be used, and its potential consequences in clinical practice. No new test should be subjected to tedious evaluation if the test is unlikely to result in improved clinical actions or measurable outcomes. Test evaluation should be carried out with carefully planned study designs appropriate for the questions addressed at each stage of development. The below steps are proposed when investigating the value of testing: Basic research into the association of disease with the new biomarker; Research into the analytical and clinical performance of tests; Clinical research into the clinical application and effectiveness of tests; Impact of testing in practice.

The evidence-based methodology of these steps is not widely understood and there are now a number of published examples on the common pitfalls and potential biases in test evaluation studies that may lead to inappropriate medical decisions and threaten patient safety. Therefore the European Commission and IVD regulatory bodies have also acknowledged that a more responsive and proportionate risk assessment during pre-market approval of new tests is needed, which involves the review of the evidence for the clinical effectiveness and impact of new biomarkers.

Terms of reference:

1. To develop a framework and guidance for the appropriate evaluation of the clinical effectiveness and impact of new laboratory tests.
2. To develop practical toolboxes which support the design and conduct of clinical research trials for the above purposes.
3. Education and training of researchers via pilot biomarker studies on how to design test evaluation studies.
4. Collaboration with epidemiologists, industry and regulatory authorities in setting standards for clinical evaluation of new biomarkers.

Deliverables:

General guidance on the process of test evaluation studies and on the best study design for the clinical evaluation of new tests at various stages of the test development process.

Criteria for test evaluation studies depending on the purpose or intended clinical application of the new test (i.e. diagnosis, screening, monitoring, risk assessment, prognosis).

Minimum reporting criteria that can also be used by regulatory or approval bodies (e.g. FDA, CE marking) assessing the clinical value of new biomarkers.
Training materials and courses on diagnostic trial design and how to conduct high quality diagnostic studies.

Representation of EFLM’s above interests at relevant international forums and commenting the revision of the EU IVD Directive at EC level accordingly. (The latter will be carried out in collaboration with EFLM’s delegates to the EC Exploratory Process on Medical Devices and jointly with EFLM’s WG-IVD).

Members

Name	Contact
Chair Ana-Maria Simundic first term 2012-2014	University Dept. of Chemistry University Hospital “Sestre Milosrdnice” Vinogradska 29 10000 Zagreb, Croatia Tel.: +385-1-3787184 Fax: +385-1-3768280 Mobile: +385-99-2554708 E-Mail: am.simundic@gmail.com
Member Giuseppe Lippi first term 2012-2014	Clinical Chemistry and Hematology Laboratory Academic Hospital of Parma, Italy E-Mail: glippi@ao.pr.it
Member Kjell Grankvist first term 2012-2014	Dept. of Medical Biosciences, Clinical Chemistry Umea University Building 6M 2nd Floor S-90185 Umea – Sweden Tel.: +46-907851262, Fax: +46-907854484 E-Mail: kjell.grankvist@medbio.umu.se
Member Mads Nybo first term 2012-2014	Dept. of Clinical Biochemistry and Pharmacology Odense University Hospital Sdr. Boulevard 29 5000 Odense C – Denmark Tel.: +45-65411161 E-Mail: mads.nybo@ouh.regionsyddanmark.dk
Member Young Scientist Michael Cornes first term 2012-2014	The Royal Wolverhampton Hospitals NHS Trust New Cross Hospital Wednessfield Road Wloverhampton WV10 0QP – UK Tel.: +45-65411161 E-Mail: michael.cornes@nhs.net
Corresponding Member Pinar Eker first term 2013-2014	Umraniye Training And Research Hospital Istanbul, Turkey E-Mail: pinareker@yahoo.com
Corresponding Member Svetlana Kovalevskaya first term 2012-2014	Labstory Company Office 312 Saint Petersburg, Russia E-Mail: kovalevskaya@labstory.ru
Corresponding Member Gunn B.B. Kristensen first term 2012-2014	NKK– Norwegian Clinical Chemistry EQA Programme Bergen, Norway E-Mail: gunn.kristensen@noklus.no
Corresponding Member Ludek Sprongl first term 2012-2014	Central Laboratory Sumperska nemocnice a.s. Sumperk, Czech Rep. E-Mail: sprongl@nemspk.cz
Corresponding Member Zorica Sumarac first term 2012-2014	Center for Medical Biochemistry Clinical Center of Serbia Belgrade, Serbia E-Mail: zsumarac@open.telekom.rs
Corresponding Member Edmée van Dongen-Lases first term 2013-2014	Dept. of Clinical Chemistry Academic Medical Center Amsterdam, The Netherlands E-Mail: e.c.vanDongen-Lases@amc.nl
Expert/Consultant Stephen Church	Becton Diskinson E-Mail: stephen_church@europe.bd.com

Members

Members

Name	Contact
Chair WG-G Wytze Oosterhuis second term 2011-2013	Dept Clinical Chemistry Atrium Medisch Centrum Henri Dunantstraat 5 6419 PC Heerlen – The Netherlands Tel.: +31-455766341 Fax: +31-455676575 E-Mail: w.oosterhuis@atriummc.nl
Member Kristin Moberg Aakre second term 2011-2013	Laboratory of Clinical Biochemistry Haukeland University Hospital Jonas Lies vei 65 5021 Bergen – Norway Tel.: +47 55973155 E-Mail: kristin.moberg.aakre@helse-bergen.no
Member Joseph Watine second term 2011-2013	Biologie Polyvalente Hopital de la Chartreuse Avenue Caylet 12200 Villefranche-de-Rouergue, France Tel.: +33-565653131 Fax: +33-565653112 E-Mail: wjoseph61@hotmail.com
Member Julian H. Barth first term 2011-2013	c/o ACB 130-132 Tooley St London SE1 2TU, UK Tel.: +44-20-74038001 Fax: +44-20-74038006 E-Mail: Julian.Barth@leedsth.nhs.uk
Member Michel R. Langlois first term 2011-2013	Dept. of Laboratory Medicine AZ St. Jan Hospital Ruddershove 10, B-8000 Bruges, Beldium E-Mail: michel.langlois@azsintjan.be
Member Young Scientist Shivani Misra first term 2012-2014	Clinical Biochemistry 8th Floor East Wing Charing Cross Hospital Fullham Palace Road London, W6 8RF, UK E-Mail: s.misra@imperial.ac.uk
Expert/Consultant Ferruccio Ceriotti	Diagnostica e Ricerca San Raffaele S.p.A Via Olgettina 60 20132 Milano – Italy Tel.: +39-02-26432282 Fax: +39-02-26432640 E-Mail: sceriotti.ferruccio@hsr.it

Terms of reference

Co-operation in defining European guidelines for the investigation and laboratory management of disease by:

1. Prepare guidelines for making recommendations for laboratory testing
2. Co-operate with clinical guidelines developers (e.g. SIGN, ADA, NICE) for the development of the laboratory part of clinical guidelines
3. Develop laboratory guidelines for reflective testing

Members

Name	Contact
Chair Päivi Laitinen first term 2011-2013	HUSLAB Clinical Chemistry and Haematology P.O. Box 340 00290 Helsinki Haartmaninkatu 4 Tel: +358 50 427 9208 E-Mail: paivi.h.laitinen@hus.fi
Member Paul Collinson first term 2011-2013	St George’s Hospital Blackshaw Road SW17 0QT London United Kingdom Tel: +44-208-725-5934 E-Mail: paul.collinson@stgeorges.nhs.uk
Member Marja P. van Dieijen-Visser first term 2011-2013	Netherlands E-Mail: mp.van.dieijen.visser@mumc.nl
Member Angelika Hammerer-Lercher first term 2011-2013	Austria E-Mail: angelika.hammerer-lercher@uki.at
Member Kari Pulkki first term 2011-2013	Dept of Clinical Chemistry (Laboratory Medicine) School of Medicine, Univ. of Eastern Finland Kuopio Eastern Finland Laboratory Centre Joint Authority Enterprise, P.O. Box 1700 FIN-70211 Finland E-Mail: kari.pulkki@uef.fi E-Mail: kari.pulkki@islab.fi
Member Young Scientist Christopher Duff first term 2012-2014	Department of Biochemistry University Hospital of North Staffordshire Stoke-on-Trent, ST4 7PX – UK Tel: +44-1782-555195 E-Mail: chris.duff@uhns.nhs.uk
Corresponding Member Ana Stavljenic-Rukavena first term 2011-2013	Hungary E-Mail: ana.stavljenic-rukavina@zg.htnet.hr
Corresponding Member Michel Langlois first term 2011-2013	Belgium
Corresponding Member Kristin Moberg Aakre first term 2011-2013	Laboratory of Clinical Biochemistry Haukeland University Hospital Jonas Lies vei 65 5020 Bergen Norway Tel: +47 55973188 Fax: +47 55975976 E-Mail: kristin.moberg.aakre@helse-bergen.no
Corresponding Member Hannsjörg Baum first term 2012-2014	Klinikum Ludwigsburg Posilipostraße 4 571640 Ludwigsburg Germany Tel: +49 7141-9965800 Fax: +49-7141-9965819 E-Mail: hannsjoerg.baum@verbund-rkh.de: hannsjoerg.baum@verbund-rkh.de