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

Abstract

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.

Keywords

• bipolar disorder
• diagnostic
• clinical study
• epigenetics