Clinical validation of EDIT-B test for the diagnosis of bipolar disorder

INTRODUCTION: Bipolar disorder (BD) is a psychiatric disorder characterized by alternating episodes of high mood and low mood similar to depression. To differentiate BD patients from unipolar (UN) depressed patients remains a challenge and the clinical scales available failed to distinguish these 2 populations. ALCEDIAG developed EDIT-B, the first blood test able to make a differential diagnosis of BD. Based on RNA editing modifications measurement and AI, the test requires a simple blood draw and equipment available in most central laboratories. A first study on 160 UN and 95 BD patients allowed a differential diagnosis with an AUC of 0.935 and high specificity (Sp=84.6%) and sensitivity (Se=90.9%). A multicentric clinical study has been set up to validate these performances. OBJECTIVES: The objective of this project is to run a multicentric clinical study in Europe and assess the performances of the test. METHODS: The EDIT-B project, led by Alcediag, is supported by EIT-Health grant (European institute of Innovation and Technology) and gathers 4 clinical centers in 3 countries (France, Spain, Danemark), a CRO for the clinical study management (Aixial), a CRO for the development of a diagnostic kit (Veracyte), a diagnostic lab for molecular biology analyses (Synlab), and a regulatory company (PLG). RESULTS: At the end of the study, the EDIT-B performance will be confirmed and the test will be CE-marked. CONCLUSIONS: This test will address the needs of millions of patients suffering from misdiagnosis and therefore allow them to receive the correct treatment. DISCLOSURE: JDA, NS and DW are employees of Alcediag.