Background
Molecular in vitro diagnostics will play an important role in future health care practices. Gene expression profiling promises to provide insight into normal biological and pathological processes with the hope of predicting disease outcome or indicating individualised courses of therapy. The ability to obtain quantitative information from a transcriptional or protein profile would be an exceptionally powerful means to explore basic biology, to diagnose disease, to facilitate drug development, to tailor therapeutics to specific pathologies or genetic profiles, and also to generate databases relevant to biological or therapeutic processes and pathways.
Critical factors for reliable analysis of biomolecules like RNA and proteins are the pre-analytical steps through to the isolation of respective target molecules. SPIDIA partners have shown that the cellular profiles of these molecules and structures in clinical samples can change during transport and storage thereby making clinical assay results and pharmaceutical research unreliable or even impossible. Without the involvement of a stabilising technology, the clinical sample will undergo drastic changes during transport and storage that would alter the profile of the target molecules. The subsequent analysis will then not determine the situation in the patient himself but an artificial profile generated during sample transport.
It is obvious that the above-described evolution of the biomolecular target profiles in biological/clinical samples cannot be tolerated in any future molecular diagnostics, pharmacology research and other fields of application. Moreover, the entire pre-analytical process from sample collection to biomolecular target isolation needs to be standardised and integrated. The final goal of this process could be to include the development of integrated kits of innovative technologies and the development of quality control schemes and guidelines for every step of the pre-analytical phase. Respective systems must be useful in all areas of the in vitro diagnostic field from classical morphological analyses to the new developing molecular diagnostic applications. For classical diagnostics, as opposed to molecular diagnostics, many standards have already been published for the pre-analytical phase.However, novel molecular diagnostics lacks clear guidelines and quality assurance schemes for the pre-analytical procedures such as sample collection, handling, transportation, processing and storing of clinical samples.
In SPIDIA, official, evidence-based guidelines and quality assurance schemes (QAS) will be developed in collaboration with standardisation bodies, notably CEN. Furthermore, breakthrough technologies will be discovered and tested in order to enable the field of molecular diagnostics to significantly grow in the future.The outcomes of SPIDIA are expected to increase the European share of the competitive IVD market whose global value is estimated at $21 billion.
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