The EU has launched a research project to increase the potential of in-vitro diagnostics by creating standards for the collection, handling and processing of blood, tissue, tumour and other samples.
The Spidia project (standardisation 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 EUR13m.
The consortium, consisting of a total of 16 companies and research institutions from 11 countries, will be led by Qiagen.
The project has been set up to standardise the pre-analytical handling of patient samples used for in-vitro (in glass) diagnosis of human diseases.
Such diagnostic procedures are performed in laboratories, hospitals and doctors' practices.
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.
For example, the molecular profiles of target molecules may change or disappear without proper treatment or stabilisation during collection, transportation or storage of the sample, making improperly handled samples useless for subsequent analysis.
'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 Commission's Directorate-General for Research.
'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.' It is believed that molecular diagnostics, in which DNA and RNA are the molecules of interest, will play a particularly vital role in future healthcare in Europe.
These molecular diagnostic methods allow earlier and more reliable information about the status of a disease than conventional methods.
Molecular diagnostics can also ease predictions concerning the future courses of diseases and lead to individualised therapeutic measures.
They are therefore viewed as fundamental to the emergence of personalised medicine.
