Vasculitides are conditions affecting the blood vessel which cause significant morbidity and mortality. Given the various vascular beds that may be involved, vasculitides have a complex symptomatology which often causes confusion in a broad range of clinical specialties. Vasculitides are considered as rare diseases; however taken together vasculitides represents a significant clinical issue and burden on public health particularly in elderly populations.

Because of their complex clinical presentation, vasculitides are difficult to diagnose. This often leads to a delayed diagnostic, a need to more aggressive therapeutic options and, often to a worsened outcome.

The diseases classified as vasculitides represents a relatively heterogeneous group of clinical entities, and the signs and symptoms vary widely according to the location of the damage (veins, arteries or capillaries), and its severity. Examples of vasculitis etiologies include Kawasaki disease, Behcet’s disease, polyarteritis nodosa, Wegener’s Granulomatosis, Takayasu’s Arteritis, Churg-Strauss Syndrome, giant cell arteritis, and Henoch Schonlein Purpura. Vasculitis can occurs as a complication of a pre-existing condition (e.g., hepatitis B, CMV, EBV, Rheumatoid artheritis, certain types of cancer), or following exposure to chemicals (e.g., amphetamines and cocaine) or medications (NSAIDs, Coxibs, PDE inhibitors, some chemotherapeuticals).

The current practices for the diagnostic of vasculitis patient currently rely on a panel of examinations often including costly imaging procedures, and unspecific laboratory parameters (CRP, ESR). These tests often aim at excluding other possible conditions but fail to provide an unequivocal diagnostic. The use of ANCA test is the unique test that is intended to specifically recognize vasculitides but the poor performance of this marker both in terms sensitivity and specificity does not allow its use as a definitive diagnostic tool. And while Invasive examinations such as biopsies can provide a specific diagnostic, they require sampling at the right time and the right location, and therefore have low sensitivity.

The need for the early recognition and treatment and the current lack of efficient diagnostic tool highlight the need for new biomarkers.

Based on preclinical studies, Firalis has identified a biomarker signature associated with the occurrence of vasculitis. Based on these candidate biomarkers, Firalis has initiated a large program (VasoDiag) in order to develop proprietary essays capable of screening these candidate biomarkers in relevant clinical samples.

The VasoDiag project is to our knowledge the first project to integrate an exhaustive list of biomarker candidates for vasculitis to be assessed in large scale multiplexed platforms and data analyzed using innovative advanced statistical methodologies, to identify the best combinations of marker in order to develop both a multiplexed assay measuring a panel of biomarkers as well as a predictive model for the interpretation of the data.

The ultimate objective of the VasoDiag program is to develop a kit containing a panel of biomarkers showing sufficient clinical utility and a predictive algorithm allowing the differential diagnostic of vasculitis. This kit and its interpretation model will be validated in clinical studies specifically designed for the exploratory translation of these candidate biomarkers.