• An estimated 2.3% of the European population is affected by bipolar disorder (BD)^[1], a largely underestimated figure, since an average of 8-10 years passes between the appearance of symptoms and diagnosis^[2]

• To date, the diagnosis of BD is based on a psychiatric clinical examination of the patient, made by a psychiatrist.

• BD is so difficult to diagnose because it is often confused with depression. Misdiagnosed patients may receive inappropriate treatment, which may even worsen their health condition.

• To significantly reduce this diagnosis wondering, ALCEDIAG and SYNLAB are announcing, on the occasion of the 31^st EPA congress, the availability of EDIT-B™, the world’s first CE-marked in-vitro blood test designed to differentiate BD from depression.

EDIT-B™: a reliable, validated and rapid biological response to reduce the diagnostic delay and address an unmet medical need.

ALCEDIAG and SYNLAB are making EDIT-B™ , based on RNA editing and AI, available to specialized healthcare professionals and their patients in Europe.

Clinically validated in two clinical studies^[3] on independent cohorts and CE IVD^[4] marked, it offers remarkable performance with sensitivity and specificity above 80%. Its objective is to help practitioners make a quicker diagnosis; reducing the diagnostic delay to a few days; patient care being consequently dramatically improved and patient management optimized.

“When the brain malfunctions, it sends signals just as a sick liver would. These signals, or biomarkers, can then be captured by a blood test, based on RNA editing, allowing for a faster diagnosis. The introduction of biology into psychiatry is a revolution”, comments Dr. Dinah Weissmann, co-founder and Scientific Director of ALCEDIAG.

“We are very proud to be part of the EDIT-B project, which will give an answer to so many patients who must face such a difficult patient journey before being diagnosed. The availability of this test will really be a game-changer in the psychiatric area”, states Giovanni Gianolli, CEO of SYNLAB Italy.     

EDIT-B™ complements the existing clinical scales. Technically, it measures the RNA editing of specific markers in patients’ blood. ALCEDIAG which developed the test and ensured its regulatory compliance, uses state-of-the-art Next Generation Sequencing (NGS) technology coupled with proprietary algorithms using artificial intelligence (AI).

EDIT-B™ is now available in Italy. It will be soon available in France and Switzerland during 2023 and gradually in other countries (SYNLAB is present 26 countries in Europe).