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

IntroductionBipolar 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 po...

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Bibliographic Details
Published in:European psychiatry 2022-06, Vol.65 (S1), p.S413-S413
Main Authors: Abraham, J.-D., Salvetat, N., Guerra, P., Ferrari, M., Le Guen, P., Biglia, O., Henry, C., Kessing, L., Haro, J.M., Vieta, E., Weissmann, D.
Format: Article
Language:English
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Abstract
Bipolar disorder
clinical study
diagnostic
E-Poster Viewing
epigenetics
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Summary:IntroductionBipolar 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.ObjectivesThe objective of this project is to run a multicentric clinical study in Europe and assess the performances of the test.MethodsThe 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).ResultsAt the end of the study, the EDIT-B performance will be confirmed and the test will be CE-marked.ConclusionsThis test will address the needs of millions of patients suffering from misdiagnosis and therefore allow them to receive the correct treatment.DisclosureJDA, NS and DW are employees of Alcediag.
ISSN:0924-9338
1778-3585
DOI:10.1192/j.eurpsy.2022.1047