DOMINO is an innovative project characterized by a high level of industrial research activities. Two industrial partners, three research institutes and several Pathological Anatomy Operative Units of different Hospitals of the Friuli Venezia Giulia Region are involved in the project. The partners during the project will compare the reference results obtained with diagnostics routine with the real samples analysis output and develop the know-how for the creation of in vitro diagnostic (IVD) products. The products will be based on DNA and RNA-NGS (Next Generation Sequencing) technology and in accordance with the In Vitro Diagnostic Medical Device Directive (98/79 / EC), will receive the CE IVD label.
Biomedical Technologies, in Vivo and in Vitro Diagnostics
The partners want to innovate the operational approach with the use of modular technology. A system composed by a sequencing platform and a bioinformatic analysis tool will be able to analyze new diagnostic target without re-performing the clinical validation of the whole panel, obtaining the complete molecular characterization of the sample, even in conditions of scarcity of material, such as the biopsies cases. The targets achieved will improve patient treatment, simplify hospital operations and optimize the economic sustainability of precision medicine.
Development and acquisition of new technological capacity for the production of an innovative diagnostic NGS technology-based devices is the main project goal. Thanks to the project activities the current skills and capabilities will leap from one generation to another and overcome the limits of present technologies. During the project the following activities will be carried out:
- to set the prerequisites for obtaining compliance with European directives on medical devices;
- validated protocols for the evaluation, treatment and extraction of nucleic acids from the tumor sample, even on small quantities;
- validated library preparation protocols for the different types of genetic variants. Developed on own design chemistry and characterized by the capacity to replace the various methods currently in use and effective even with small amounts of sample;
- a validated bioinformatic analysis pipeline system for the analysis of the different types of genetic variants.