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Posted: January 13, 2009

New guidelines open up the potential of molecular diagnostics

(Nanowerk News) A new EU-funded research project is set to lead the way in creating top-quality healthcare standards for in vitro diagnostics, an area of medicine that could be of vital importance to personalised medicine.
SPIDIA ('Standardisation and improvement of generic pre-analytical tools and procedures for in vitro diagnostics') has recently got off the ground with EUR 9 million from the EU's Seventh Framework Programme (FP7) under the Health research Theme. The 4-year molecular biology project brings together 16 partners, including 4 small- and medium-sized enterprises, from 11 countries. Clinical chemists and pre-analytical diagnostic tool developers will work to develop new in vitro analysis techniques and standards.
In vitro diagnostics are tests that are carried out on samples of body tissues or fluids, such as blood or saliva. They give vitally important information about the body's state of health and the presence of disease. They are being used increasingly to monitor the progress of a disease or condition in a patient, to help doctors make the best decisions about which course of treatment to follow.
Standardisation is crucial for the viability of pre-analytical collection, handling, transportation and storage of patient tissue materials for in vitro tests. Tissue samples are critical for accurate test results, but at present there are many sample processing methods that can lead to changes in or degradation of samples. Currently, the molecular profiles of sample molecules may disappear or undergo changes because there are no standardised stabilisation methods during collection or storage. This can lead to the redundancy of a sample.
'Far too many differing sample-processing methods which then lead to different results are still being used,' said Arnd Hoeveler, Head of Unit of the European Commission's Biotechnology for Health Directorate. 'This variance 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.'
SPIDIA will be coordinated by Qiagen, a Netherlands-based sample and assay technology firm. Mr Peer M. Schatz, Qiagen's CEO, said, 'Qiagen welcomes this initiative and considers it extremely important in paving the way for a significant expansion of the potential of in-vitro diagnostics. 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.'
Expanding the potential of in vitro tests may lead to breakthroughs in the area of molecular diagnostics (in which DNA and RNA play a crucial part), which will be of central importance to European healthcare in the future. 'Personalised medicine', in which a patient's personal DNA profile will be used for diagnosis, will be able to offer far more accurate information than conventional diagnosis.
By 2012 SPIDIA intends to have in place a firm set of standards and guidelines for the handling of vitro samples. The project also intends to develop new standards for the actual analysis of tissue material.
Source: Cordis