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Qiagen to Lead EU Project to Develop IVD Standards

NEW YORK (GenomeWeb News) — Qiagen said today that it will lead a European Commission research consortium of 16 companies and institutions from 11 countries whose goal is to create new standards for handling and processing samples for in vitro diagnostics.

Funded with more than €13 million ($17.4 million) from the 7th Framework Program, the four-year Standardization and improvement of generic Pre-analytical tools and procedures for In-vitro DIAgnostics, or SPIDIA, project will attempt to develop new standards for collecting, handling, and processing blood, tissue, tumor, and other sample materials.

"Far too many differing sample processing methods, which then lead to different results, are still being used," Arnd Hoeveler, head of Health Biotechnology in the Health Directorate of the Commission's Directorate-General for Research, said in a statement.

Hoeveler said this variation "hampers the comparability and reproducibility of results and reduces the meaningfulness of the analyses," and proposed that standardized guidelines and quality-assurance plans will help "introduce new and better diagnostic methods."

The project also plans to develop standards for other IVD steps, such as the actual analysis, "further along the road," Qiagen said in the statement.

The consortium will share its first results after two years, and after the project ends the company said it expects that "uniform guidelines for the execution of the entire in vitro diagnostic process should be in place."

SPIDIA also includes partnerships with universities and institutes in Munich, Germany; Florence, Italy; Graz, Austria; Prague, Czech Republic; and Rotterdam, the Netherlands. It also includes contributions from the International Agency for Research and Cancer and the European Standardization Committee.

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