In the past decade, exosomes receive exponentially growing attention due to their recently understood significance as key elements facilitating intercellular communication. The power of exosomes as biomarkers relies on the enrichment of highly selected markers, which otherwise constitute only a very small proportion (less than 0.01%) of the total secretome of body fluids. The enrichment of diagnostic markers at the exosomal source, due to cargo sorting into exosomes, helps the discovery of relatively lowly expressed biomarkers that normally would go undetected. The most promising application is certainly the diagnosis and monitoring of certain cancers. Despite all their potential in diagnostic and therapeutic use, the transition of exosome-based applications from lab to clinic is hindered by a number of technical barriers. The greatest of these barriers is probably the lack of a gold standard, optimal method and technology to isolate exosomes from bodily fluids that is necessary for all downstream applications. The conventional protocols involving multiple ultracentrifugation steps are tedious, time-consuming and inefficient; and not applicable in the clinical setting.
Our scientific team has established optimal conditions for the isolation of exosomes by size-exclusion chromatography and identified optimal column materials for the process. Based on these results, we decided to develop a platform consisting of an equipment and consumables bespoke for most specific needs in exosome isolation from complex biofluids, such as blood. The innovative tools we propose to market will increase the quality, the throughput and the reproducibility; and decrease the required time of exosome isolation. Use of the platform will require minimal experience in chromatography, thereby decreasing barrier to enter the field.
In the Phase 1 project our overall objective was to assess the feasibility of our technological and commercial approach before continuing with the next stage of the development. As our key assumptions have been confirmed, the conclusion of this assessment was to continue with the development
