The assay based on glycan analysis was optimized in an ELISA-like (Enzyme-linked immunosorbent assays) format, which is compatible with standard clinical practice. In order to make the assay as short as possible, we needed to optimize the composition of magnetic particles applied in the assay format by consultation with a provider of magnetic particles. The other important issue we focused on was to decrease the variability of sample analysis by using an automatic pipetting machine. We are currently investigating how the assay protocol from an ELISA-like format analysis can be made compatible with solution-based assays, which are also used at clinical labs requiring moderate and high-throughput sample assays.
Pre-clinical validation was then run using an optimal assay protocol in an ELISA-like format using 140 samples from the Austrian biobank. Samples were chosen from a grey zone when it is difficult for the urologist to decide if the level of a current prostate cancer biomarker – PSA (prostate specific antigen) really indicates prostate cancer or not. Pre-clinical validation showed that glycan-based assays can be applied for diagnostics of prostate cancer (i.e. to differentiate healthy men from prostate cancer patients) and for prognostics of the disease (i.e. to distinguish prostate cancer patients at an early stage from those with an advanced form of the disease) with accuracy significantly outperforming current PSA analysis.
We prepared a full package necessary for fundraising (2 pager, investor´s pitch, web page, etc.) and we pitched to 3 angel investors (2 from Slovakia and 1 from Switzerland) and to 2 Slovak VC funds. At the same time, start-up Glycanostics pitched at several start-up competitions (Vodafone Idea of the Year, Czech Republic – 3rd place; Future Now, Slovakia, but opened to start-ups from Central and Eastern Europe – Top 6; Central European Startup award, Slovakia – prize for Social impact startup and for Health-tech startup) and the startup was part of an intensive bootcamp and an incubator.
In cooperation with the Slovak consulting company, we are working on regulatory and commercialization assessment for the company, as well as on strategy for marketing and sales. Currently, we are negotiating the possibility to cooperate with biotech/diagnostic companies on the development of our assay protocol in a way to be fully compatible and operational on their detection platforms.
