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

Published online by Cambridge University Press:  01 September 2022

J.-D. Abraham ,
N. Salvetat ,
P. Guerra ,
M. Ferrari ,
P. Le Guen ,
O. Biglia ,
C. Henry ,
L. Kessing ,
J.M. Haro  and
E. Vieta
...Show all authors
J.-D. Abraham*
Affiliation:
Alcediag/Sys2Diag, Neurology, Montpellier, France
N. Salvetat
Affiliation:
Alcediag/Sys2Diag, Neurology, Montpellier, France
P. Guerra
Affiliation:
Product Life Group, Plg, Suresnes, France
M. Ferrari
Affiliation:
Synlab, Italy, Monza, Italy
P. Le Guen
Affiliation:
Aixial, France, Boulogne-Billancourt, France
O. Biglia
Affiliation:
Veracyte, Luminy Biotech Entreprises, Marseille, France
C. Henry
Affiliation:
Institut Pasteur, Unité Perception Et Mémoire, Paris, France
L. Kessing
Affiliation:
The Copenhagen Affective Disorder Research Center, Rigshospitalet, Copenhagen, Denmark
J.M. Haro
Affiliation:
Parc Sanitari Sant Joan de Déu, Fundació Sant Joan De Déu, Cibersam, Barcelona, Spain
E. Vieta
Affiliation:
University of Barcelona, Hospital Clinic, Barcelona, Spain
D. Weissmann
Affiliation:
Alcediag/Sys2Diag, Neurology, Montpellier, France
*
*Corresponding author.

Abstract

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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 disorderdiagnosticclinical studyepigenetics
Type
Abstract
Information
European Psychiatry , Volume 65 , Special Issue S1: Abstracts of the 30th European Congress of Psychiatry , June 2022 , pp. S413
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Author(s), 2022. Published by Cambridge University Press on behalf of the European Psychiatric Association
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