Work performed in LIQBIOPSENS project can be divided in eight main activities:
1) Development of a disposable test cartridge that acts as the basic sensing unit of the whole system. During the project, a disposable test cartridge prototype has been developed and characterized. A complete production procedure, including quality control and sensor surface functionalization methods, has been implemented.
2) Development of a kit of chemical reagents to be used with the disposable test cartridge for the determination of up to 27 different mutations in the KRAS and BRAF genes. During the project, DestiNA has designed DGL probes and the chemistries needed for the preparation of SMART Nucleobases containing different tags, the “so called” BOT-SMART Bases. These reagents have been characterized and tested.
3) Optimal integration of both the sensing technology of AWSENSORS and the chemical DNA testing technology of DESTINA. FORTH has developed a complete acoustic detection protocol that has been applied to the final LIQBIOPSENS platform.
4) LIQBIOPSENS project deals with the market-oriented evolution of the LIQBIOPSENS platform. A prototype platform has been developed considering the very useful feedback from the end-users and liquid biopsy market trends. Developments carried out include mechanical and thermal design, electronic hardware, firmware and software implementations, and the integration of an automatic liquid handling systems capable of running different assay protocols autonomously.
5) Validation of the prototype in real application scenarios. During the project, the clinical validation study has been planned. A cohort of CRC patients with different mutations in KRAS and BRAF genes have been recruited for the validation study. Samples have been obtained and stored and patient data kept in a sample data base. Quality of the extracted DNA has been checked. A training program has been followed by the validation team to learn how to use the Liqbiopsens platform. Finally, real samples have been evaluated by Liqbiopsens platform and the results compared with reference analytic methods.
6) Innovation management allowed us to define a methodology to select and prioritize the implementation of new features. A very comprehensive report has been generated on companies developing or commercializing their own liquid biopsy tests or platforms. Following EC recommendations, Liqbiopsens market positioning study has been included, as well as a preliminary FtO (Freedom to Operate) analysis.
7) Exploitation activities consisted on the development of a comprehensive business plan to transfer the results of the project to the society. Liquid biopsy market study carried out within innovation management activities have been used as starting point to develop our exploitation strategy. A Joint Venture company has been selected as the optimal vehicle to implement the necessary steps to commercialize the valuable results of the project.
8) Last but not least, efforts in dissemination have also been made during these 36 months. A dissemination, communication and exploitation strategy has been planned. A project website has been developed based on this strategy. Two LIQBIOPSENS brochures have been designed and released. Press notes and articles for the general public have been launched. Consortium has attended workshops and conferences and scientific papers have been published in international open source peer reviewed journals. Other important achievement encompassed in the dissemination activities is the Foundation of “International Society of Liquid Biopsy”.
