EDIT-B®

Unlocking precision psychiatry:  simple and swift blood test to differentiate depression and Bipolar Disorder in adults, surpassing 80% Sensitivity and Specificity

EDIT-B®

Unlocking precision psychiatry:  simple and swift blood test to differentiate depression and Bipolar Disorder in adults, surpassing 80% Sensitivity and Specificity

EDIT-B® is a qualitative In Vitro Medical Device (IVD) intended for the differentiation of bipolar disorder from depression. The test is intended to be used in patients aged 18 years and older, male, or female, with a moderate to severe depression being treated for that depression.

EDIT-B® is as a decision-making support tool for mental healthcare professionals to complement the clinician diagnostic and faster the selection of the appropriate therapeutic treatment, avoiding in particular the diagnosis wondering usually associated with bipolar disorder.

EDIT-B® is patented, CE marked and clinically validated on independent cohorts. Since 2016, Alcediag has been conducting large-scale clinical trials involving over 800 patients showing a sensitivity and specificity over 80%. For more information about clinical trials, please click here.

EDIT-B® is based on RNA sequencing technology and Artificial Intelligence (AI). It uses RNA-editing modification patterns measured in whole blood, as well as individual patient data (e.g.: age, sex, treatment(s), addiction(s)). For more information, please click here

About Depression & Bipolar Disorder

Mental disorders are classified as one of the 10 most incapacitating pathologies. Depression is one of the most common ones with an estimated 5% of adults or 280 million people suffering from it according to the World Health Organization. Bipolar disorder is one of the most serious with 40 million people diagnosed worldwide in 2019, and a high level of underdiagnosis. In Europe, it is estimated between 2% and 4% of the population is affected by this chronic mental illness. 

Depression is characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in daily activities. Individuals experiencing depression may also struggle with changes in appetite, sleep disturbances, and a pervasive sense of fatigue. This condition can significantly impact not only the individual’s daily functioning but also strain relationships with family and friends.

On the other hand, bipolar disorder is a chronic disease marked by mood swings, cycling between periods of mania or hypomania and severe depression. During manic episodes, individuals may experience heightened energy levels, impulsivity, and a decreased need for sleep. These episodes are followed by depressive periods characterized by the symptoms mentioned earlier. The nature of bipolar disorder can be challenging for both the affected individuals and their loved ones, as it may lead to difficulties in personal and professional lives.

The Current Diagnosis & its Challenges

Today, the diagnosis of BD is mainly based on a psychiatric examination, carried out by a specialist using questionnaires and several validated scales.

According to NAMI (National Alliance on Mental illness), the typical delay for receiving a diagnosis of bipolar disorder is between 6 to 8 years. Several publications highlight the difficulty to accurately diagnose it (Bipolar disorder diagnosis: challenges and future directions): “Bipolar disorder is an especially good example of a group of psychiatric illnesses that are difficult to diagnose accurately. For example, although this disorder, along with other psychiatric illnesses, is one of the ten most debilitating of all non-communicable diseases, misdiagnosis of the illness as recurrent unipolar depression occurs in 60% of patients seeking treatment for depression”.

Recognizing the symptoms and seeking a timely diagnosis is crucial for effective treatment and management of both depression and bipolar disorder. Proper diagnosis allows for the implementation of tailored treatment plans, which may include therapy, medication, or a combination of both. Additionally, the support of family and friends plays a vital role in the overall well-being of individuals dealing with these mental health conditions.

Partners & Availabilities

As an In Vitro Diagnostic test, EDIT-B® is prescribed by a psychiatrist and requires a blood draw that is performed according to local standards. The test is exclusively conducted within medical biology laboratories. EDIT-B®. For more information, please refer to the FAQ – Frequently Asked Questions available in the Resources section.

EDIT-B® is available in some European countries under the name MyEDIT-B via an exclusive partnership with Synlab Group.

https://www.synlab.com/human/news/news-article/synlab-launches-revolutionary-bipolar-disorder-diagnostic-test-myedit-b-135

https://www.synlab.it/servizi/analisi-di-laboratorio/editb.html

In the landscape of Psychiatry, traditionally steered by clinical insights, we now stand on the cusp of Precision Psychiatry. Amidst the global prevalence of bipolar disorder, often under-diagnosed and mis-diagnosed due for example to the absence of manic episodes in some patients, a revolutionary era emerges. With a biomarker signature unveiled through a simple blood test, diagnostics can be turned into a realm of objectivity. This not only addresses the pervasive challenges of accurate identification of Bipolar Disorder but propels us into a future where mental health care is finely tuned to human biology. Beyond a test, it’s a promise of personalized therapies, optimized outcomes, and a brighter path to mental well-being for individuals, families, and society at large.

Eduard Vieta, MD PhD

Principal Investigator in the clinical trial, EDIT-B project, University of Barcelona and Head of the Department of Psychiatry Hospital Clinic Barcelona

I’m excited that in my lifetime we will finally have a reliable, precision psychiatry diagnostic tool for bipolar disorders.

David J. Kupfer, MD

World renowned expert of bipolar disorder – Distinguished Professor Emeritus of Psychiatry, University of Pittsburgh School of Medicine – Advisor for ALCEDIAG since 2014, DSM-5 Task Force Chair