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.
EFCC 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.
EFCC and SPIDIA
EFCC 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 EFCC 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 EFCC 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. EFCC 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 (EFCC). 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.
