EDIT-B: Fighting the diagnostic delay of bipolar disorder

Bipolar disorder is a mental health condition that causes extreme shifts in a person’s mood and energy level. Globally, 45 million people [1] are correctly diagnosed and treated for bipolar disorder. More concerning though is that bipolar disorder is often confused with depression, meaning that of the 300 million people currently living with unipolar depression [2], 40% could be misdiagnosed and potentially have bipolar disorder [3]. Because of this, an accurate diagnosis in many countries can be as long as 8 years [4]. 

Living with undiagnosed bipolar disorder can be incredibly challenging, because without a proper diagnosis and effective treatment, the strain of coping can exacerbate feelings of isolation and hinder the ability to lead a fulfilling life. The undiagnosed individual may grapple with unpredictable mood swings and intense emotional fluctuations, and the lack of clarity this brings about the root cause of these episodes can lead to confusion, self-doubt, and strained relationships as they struggle to manage their symptoms alone. [5] 

Navigating through the world without a diagnosis 

Isabel, who was diagnosed with bipolar disorder in 2009 and features in the short film, said: “Not having a diagnosis is like being in a well, it’s very dark because you know you’re not okay, but you don’t know what’s wrong with you. And until you get the diagnosis you can’t think about how to go about recovering. For me an earlier diagnosis would have meant everything because it would have saved me a very hard and very difficult stage of my life.” 

No diagnosis, or misdiagnosis can have devastating consequences to an individual’s life as well as negatively affecting healthcare systems. The societal cost of just one year’s delay in diagnosis is estimated at €50k per patient in Europe [6], and because medical treatment differs substantially between bipolar disorder and unipolar depression, a misdiagnosed prescription of antidepressants can be harmful to bipolar patients, who are at risk of worsening their condition and developing comorbidities.

A simple blood test helps practitioners make a quicker diagnosis 

The EIT Health supported EDIT-B consortium is tackling this diagnostic challenge with myEDIT-B, a blood test that’s used in the clinical daily routine as a diagnostic aid for psychiatrists to differentiate unipolar depression from bipolar disorder. With no equivalent test on the market, the main objective of the myEDIT-B test is to provide objective biological data, complementing the psychiatrists’ consultation, to provide an accurate and rapid differential diagnosis to drastically reduce the delay in diagnosis as well as the misdiagnosis with harmful consequences for the patient. EDIT-B has already undergone clinical validation in two studies on independent cohorts, and is CE IVD marked, boasting sensitivity and specificity rates above 80% [7].

Find out more about myEDIT-B and the people it’s helping 

ALCEDIAG, which leads the consortium, is a French-based diagnostic company whose ambition is to advance precision psychiatry by introducing biology into clinical routines using editing-based RNA biomarkers and Artificial Intelligence to change the lives of millions of patients. 

When the brain malfunctions it send signals, just as a sick liver would. ALCEDIAG realised that by capturing these signals, or biomarkers, via a blood test that detects alterations in RNA molecules, a process known as RNA editing, they could identify a person living with undiagnosed bipolar disorder.  

This short film is all about the power of teamwork and tells the story of ALCEDIAG’s journey and their collaboration with EIT Health Partners with differing expertise to help healthcare professionals improve the diagnostic outcomes for people living with bipolar disorder. 

EIT Health helped ALCEDIAG realise their idea 

With a potentially life-changing solution on their hands, ALCEDIAG realised they would need to work with the right partners to help test and develop myEDIT-B at scale, navigate the complex regulatory requirements and ensure the solution reaches as many people as possible in Europe and beyond.  

Alexandra Prieux, CEO of ALCEDIAG, said: “It’s not always easy if you want to do something meaningful. You always have difficulties in the research, commercialisation and regulatory spaces. So, bringing an innovation to market is a long and difficult journey. EIT Health has a vision for innovation and was willing to help us in developing an innovation in mental health.” 

EIT Health not only provided ALCEDIAG with critical funding (€2.5M) to kick-start the project but, more importantly, as part of the EIT Health network, connected them to suitable EIT Health Partners.  

The subsequently formed EDIT-B consortium, enabled ALCEDIAG to work with world-class experts in mood disorders and in 2023, launch myEDIT-B in Italy, two years’ ahead of schedule. In 2024 on World Bipolar Day, 30 March, myEDIT-B launched in France and the consortium members are now working to ensure the solution reaches Europe and beyond. 

Watch our short film at the top of this page to learn how EIT Health connects innovative companies, such as ALCEDIAG, to Partners with different specialisms to help solve an unmet need.

A special thanks to our consortium partners: Alcediag, Alcen, Capital Region of Denmark, Fundació Clinic per la Recerca Biomèdica, Fundació Sant Joan de Déu, GHU Paris Psychiatrie & Neurosciences, Hospital Clínic de Barcelona, Parc Sanitari Sant Joan de Déu, ProductLife Group, and Synlab.