Project title: VASCUDIA: a novel multi-parametric diagnostic tool for diagnosis of vasculitis
Rationale:Biomarkers, patient data and covariates will be used in combination for accurate diagnosis of vasculitis and vasculitis flare. Extensive exploratory work has established a panel of potential biomarkers that are ready to move to TRL 4 on the path to commercialisation.
Objectives:Develop and clinically qualify an IVD test Multivariate Index Assay for diagnosis of different forms of vasculitis: Isolate (i) minimal biomarker set for diagnosis of active vasculitis (Objective 10), (ii) best performing biomarkers for differential diagnosis and disease activity (Objective 10), (iii) best performing patient data and covariates (Objective 10). Create software for results interpretation and decision making for clinicians: VASCUDIA software tool to include multiplex immunoassay on the Quantamatrix platform for future clinical application/submission for FDA CFR21 Part 11 qualification (Objective 11).
Expected Results:Software algorithm capable of handling multiple parameters and generating multiple decision trees based on available and missing data.
Planned Secondments:KTH: 4 mths (to validate proteomic analyses)