FADEQ · Fully automated cell-free DNA extraction and quantification - liquid biopsies safely from Patient to Lab

Liquid biopsies are blood tests with growing potential in diagnostics for cancer and prenatal screening. Pre-analytical challenges, such as the need for skilled workforce and strict logistic requirements for samples transportation, are limiting the full exploitation of the method. To address these technical issues, we developed a method for immediate and automated sample processing that provides a sample with higher reliability, less human labour, and less transport requirements. BiopSense innovation is a fully automated disposable cartridge, where the blood is filtrated using a dedicated hollow fiber membrane and then cfDNA is isolated from the plasma in the microfluidic system. The resulting sample can be then transported by regular post and eluted at the destination to carry out the final analysis. The cartridge is controlled by a control unit composed of a vacuum generator, software, and a simple spectrophotometer. In this EIC Transition project our objectives are to validate the automated cfDNA extraction technology and to integrate all the features of the innovation in a single disposable cartridge, which will be ready for marketing, licensing and IVD validation by the end of the project. The cartridge design will be done in close collaboration with the potential customers sector (biotech companies and hospital laboratories) to use their feedback to develop the user interface, manufacturability, and regulatory compliance. The project will focus on the cartridge design and will outsource control unit development to a company with experience in vitro diagnostic devices designing and production. In this project the commercialisation strategy for the next 5-10 years will be developed to define how our start-up company BiopSense will handle the disposable cartridge design and commercialization, and further R&D of the technology in additional applications.