Autoimmune encephalitis (AiE) is a severe brain inflammatory disorder produced by an immune attack to neurons. Detection of neuronal antibodies in patient serum and cerebrospinal fluid, is key to establish adefinitive diagnosis. AiE affects patients of all ages, with complex neuropsychiatric symptoms, and the differential diagnosis with non-autoimmune disorders, such as infectious, toxic or degenerative diseases, is often a challenge. A rapid and accurate diagnosis is important in order to provide early treatment with immunotherapy, and improve patients’ outcome. The current AiE diagnostic tests are not perfect and can produce false positive and false ngative results. Moreover, in the last years new antibodies are being discovered, and negative results on the widely available diagnostic kits do not rule out AiE. To solve the problem, we developed a novel platform (NeurAntigen Kit) with significant advantages over existing technologies: i) is based on neurons derived from human induced pluripotent stem cells and ii) includes non-neural cells as a control. First experiments validate that our kit is able to detect antibodies directed to all AiE surface antigens known so far. Thus, our method has a high potential impact, increasing the sensitivity (unrestricted human neuronal antigens) and the specificity (self-controlled with non-relevant antigens) of AiE diagnostic tests on a single assay. Using NeurAntigen Kit as first diagnostic step will reduce unnecessary antigen-specific tests for patients with negative results (AiE excluded) helping in clinical decisions, thus impacting on treatment and prognosis. Next steps will allow us to complete the preclinical studies, perform a clinical validation of the Kit with patients’ samples obtained from three different reference laboratories for AiE in Europe, and assess the diagnostic value of the kit. Moreover, we will also consolidate our IPR strategy and determine the best strategy for tech transfer.
