TAXINOMISIS combined expertise in multidisciplinary areas to provide new knowledge on the clinical, biological and engineering domains. From a biological point of view, cellular composition of plaque specimens was assessed using mass cytometry (a novel platform for high-dimensional phenotypic and functional analysis of single cells) revealing a prevalence of T cells and myeloid cells. Ceramides and phosphatidylcholines were identified as potential markers for high-risk patients. Cardiovascular disease-related proteins in plasma extracellular vesicles (cell-derived membrane-surrounded vesicles that carry bioactive molecules and deliver them to recipient cells) were associated with major adverse cardiovascular events. Five new endotypes were defined by clustering atherosclerotic plaque and plasma patient samples into biologically and clinically relevant disease subtypes namely fibrous, inflammatory, lipo-necrotic, fibro-inflammatory, and fibro-productive. Lipo-necrotic and fibro-inflammatory were associated with high risk, inflammatory with intermediate risk and fibrous and fibro-productive with low risk.
TAXINOMISIS developed two tools: the risk stratification tool and the lab-on-a chip. The risk stratification tool is a user-friendly, cloud-based platform addressing the standard of care gaps in risk stratification and decision making. Risk assessment is provided using machine learning algorithms, computational fluid dynamics and predictive modeling. The platform considers various data such as personal information, blood exams, medication, and imaging data and was validated using data from 345 patients participating in the TAXINOMISIS observational clinical study. The risk stratification tool is based on a 3-level approach defined by clinical experts. The first level utilizes cutting-edge machine learning algorithms to predict more accurately an individual's risk of carotid artery disease. The second level leverages the power of computational fluid dynamics to simulate blood flow. The calculation of wall shear stress enhances the understanding of the mechanical forces contributing to plaque buildup. The third level uses computational models to simulate the progression of plaque over time allowing clinicians to forecast plaque growth and identify high risk patients.
In addition, a lab-on-a-chip device was developed and tested. Thirteen different single nucleotide polymorphisms (a variation at a single position in a DNA sequence among individuals) were detected which are relevant for patient treatment. The single nucleotide polymorphisms’ detection was based on quantitative polymerase chain reaction, a technique that combines amplification of a target DNA sequence with quantification of the concentration of that DNA species in the reaction.
The regulatory roadmap of TAXINOMISIS was defined. The risk stratification tool was categorized as class IIb according to Regulation (EU) 2017/745 on medical devices. The lab-on-a-chip was categorized as class A (instrument) according to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices.
The TAXINOMISIS results were disseminated and communicated using Journal and conference publications, exhibitions, demonstrations to experts, social media, and videos. Exploitation and commercialization activities included market analysis, Intellectual Property Rights and a business model. Also, a patent has been submitted.
