The objective of the DOMINO project is to develop know-how for the creation of in vitro diagnostic (IVD) products based on DNA and RNA sequencing technology—Next Generation Sequencing (NGS)—that can obtain CE IVD marking in compliance with the In Vitro Diagnostic Medical Devices Directive (98/79/EC).
OBJECTIVES
Through next-generation sequencing technologies, the DOMINO project aims to develop and validate a line of in vitro diagnostic (IVD) products to be used in oncology. The performance of this innovative system will surpass current molecular biology techniques, enabling the expansion of target regions to investigate and thus identifying various types of genetic variants. Within a system composed of a sequencing platform and a bioinformatics analysis tool, the partners aim to innovate the operational approach by employing modular technology capable of analyzing a new diagnostic target without revalidating the entire panel clinically. This will allow the complete molecular characterization of the sample, even in cases with limited material, such as in biopsies.
The achieved objectives will improve patient treatment, streamline hospital operations, and optimize the economic sustainability of precision medicine.
RESULTS
The main outcome of the project is the development and acquisition of the necessary technological capability to create innovative diagnostic devices based on NGS—Next Generation Sequencing technology. The project will lead to a generational leap in terms of skills and capabilities, overcoming the limitations of established technologies. Throughout the project, the following will be defined:
- the essential requirements to achieve compliance with European medical device directives;
- validated protocols for the evaluation, treatment, and extraction of nucleic acids from tumor samples, even in minimal quantities;
- validated library preparation protocols for different types of genetic variants, developed with proprietary chemistry and capable of replacing current methodologies, effective even with minimal sample quantities;
- a validated bioinformatics analysis pipeline system for analyzing different types of genetic variants.