Every year, ovarian cancer (OC) kills more than 40 000 women in Europe and 150 000 worldwide. In large part this is due to the fact that most women are not diagnosed until advanced stages. There is an urgent unmet clinical need for screening tools for the early, accurate identification of OC. OC is associated with alterations in glycosylation of secreted glycoproteins, and as such, they can serve as early OC biomarkers. However, this knowledge has still not been translated into clinic due to the lack of assays that can differentiate subtle differences between glycan chains.
In this project, we have developed a high-throughput clinical assay for the specific identification of unique overall glycan structures associated with ovarian cancer in serum. The assay incorporates our glycan recognition technology in the high-throughput Luminex platform, which is globally used in clinical diagnostics. Imprinted (molecularly moulded) nanoparticles have been produced that can selectively bind glycans. This nanoparticle development is based on our patented technology (Patent No: WO2015/118294). As part of the project, a strategy has been also devised to functionalise the glycans associated with OC that reduces significantly the costs of the glycans used to create the imprinted nanoparticles. The assay has undergone a series of optimization steps and extensive analytical validation to ensure reproducible results and we have now well-defined standard operating procedures in place.
Through this project we have developed a novel assay that has the potential to radically change the diagnostic standard of care for OC, ultimately saving lives and reducing the health, social and economic burden imposed by OC. Further clinical validation will be sought in the future to strength the validity of the new assay and bring it to the market.
