By: Richard Park

TRENDS & PERSPECTIVES

The European Union launched a new research project that intends to expand the potential and utility of IVDs by creating new standards for collecting, handling, and processing blood, tissue, tumor, and other sample materials. Under the 7th Framework Program, the European Commission approved this initiative's funding and scope to develop corresponding standards, tools, and quality assurance schemes.

The Standardization and Improvement of Generic Preanalytical Tools and Procedures for In Vitro Diagnostics project (SPIDIA) is scheduled to run for four years and has a total budget of more than 13 million €. The consortium involved in the project consists of 16 companies and research institutions representing 11 countries, and will be led by Qiagen GmbH (Venlo, The Netherlands).

“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 variance hampers the comparability and reproducibility of results, and reduces the meaningfulness of the analyses. More standardized guidelines and quality assurance schemes will help to introduce new and better diagnostic methods, which will benefit all European patients.”

Some of the companies and institutions participating in this project, along with their respective tasks, include the following:

• ACIES (Lyon, France): Strategic and operational project management.

• Aros Applied Biotechnology A/S (Aarhus, Denmark): Optimization of preanalytical work flows for molecular diagnostics of colorectal cancer using whole blood samples.

• Biotechnology Institute of the Czech Academy of Sciences (Prague, Czech Republic): Training, dissemination, and exploitation of SPIDIA's findings.

• Dako Denmark A/S (Glostrup, Denmark): Optimization of the preanalytical work flow in the pathology laboratory in order to improve cancer diagnostics.

• DiaGenic ASA (Oslo, Norway): Optimization of preanalytical work flows for biomarker discovery programs for Alzheimer's disease.

• Erasmus Medical Center Rotterdam, Department of Pathology (Rotterdam, The Netherlands): Project ethics, pathological evaluation of new tools, and procedures for preanalytical tissue handling.

• European Committee for Standardization (Brussels): Converting the standardized protocols and procedures for preanalytical handling of blood and tissue samples into technical guidelines.

“Qiagen welcomes this initiative and considers it extremely important in paving the way for a significant expansion of the potential of IVDs,” said Peer M. Schatz, Qiagen's chief executive officer. “The ongoing standardization of the collection, handling, and processing of relevant samples will speed up the dissemination of new IVD methods. With its support of this project, the commission 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 in particular.”

SPIDIA's overall purpose is to provide official pan-European quality assurance schemes and guidelines for the preanalytical phase of IVDs, allowing the analysis of both cell morphology and biomolecules in one sample.

Such guidelines will be based on evidence gathered during trials that will elucidate problematic steps in preanalytical procedures, with a specific focus on DNA, RNA, protein, and metabolite targets isolated from tissue, tumor, and whole blood samples. Quality assurance biomarkers will also be discovered to serve as indicators of effective stabilization or degradation/induction for such samples.

In addition, the project's objectives include the development of new integrated preanalytical tools that will help to improve sample collection, stabilization, handling, storage, transport of blood and tissue samples, and extraction of biomolecules such as proteins, DNA, RNA, and metabolite from such samples.

The ultimate goal for such integrated systems for blood and tissue samples is to protect the molecular and cellular integrity of the samples. For tissue samples, such systems will enable generating reliable data and diagnoses through tissue and tumor morphology, biomolecular assays, immunohistochemistry, and staining from one sample. For blood samples, the aim is to support IVD analysis based on RNA, DNA, and other blood biomolecule assays from the same sample.

Additional information about this project can be accessed from the SPIDIA Web site at www.spidia.eu.