The SPIDIA project (standardisation and improvement of generic pre-analytical tools and procedures for in-vitro diagnostics) will be run by a consortium of 16 companies and research institutions from 11 countries, and will be led by the Dutch firm Qiagen.
The four-year €13 million project will expand the potential and utility of in vitro diagnostics through the creation of new standards for the collection, handling and processing of blood, tissue, tumour and other sample materials, whether carried out in laboratories, hospitals or doctors’ practices. The project will also develop associated tools and quality assurance schemes.
These handling procedures are critical, since the reliability of the subsequent analysis – and thus the accuracy of the diagnosis – is dependent upon the integrity of the sample. For example, the molecular profiles of target molecules may change or disappear if samples are not properly treated and stabilised during collection, transportation or storage.
“Far too many differing sample processing methods, which then lead to different results, are still being used,” said Arnd Hoeveler, Head of the Health Biotechnology Unit in the Health Directorate of the European Commission’s Directorate-General for Research. “This hampers the comparability and reproducibility of results and reduces the meaningfulness of the analyses. More standardised guidelines and quality assurance schemes will help to introduce new and better diagnostic methods, which will benefit all European patients.”
The project will pave the way for a significant expansion of the potential of in vitro diagnostics, says Peer Schatz, CEO of Qiagen. “The ongoing standardisation of the collection, handling and processing of relevant samples will speed up the dissemination of new in vitro diagnostic methods. With its support of this project, the Commission is providing strong leadership in emphasising the importance of these processes in general and molecular diagnostics and their role as cornerstones of future healthcare in Europe in particular.”
SPIDIA also intends to develop standards for the actual analysis. At the end of the four years a proposal for quality controls and uniform guidelines for the execution of in vitro diagnostics should be in place. The network expects to share the first results after two years.
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