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12 Jul 2022

ALCEDIAG Announces the Inclusion of the First Patient in clinical validation study for EDIT-B test: an aid for differential diagnosis of bipolar disorder, based on RNA editing blood biomarkers

Paris & Montpellier, France July 12, 2022. Diagnostics company ALCEDIAG announces today the inclusion of the first patient at the GHU center (Paris) in the clinical validation study for EDIT-B test.

EDIT-B is an innovative blood test that uses specific RNA editing-based biomarkers, next-generation sequencing (NGS) and artificial intelligence to help clinicians distinguish between bipolar disorder and major depressive disorder. This clinical study intends to validate clinical results that were discovered in prior studies and should assist in resolving the current diagnostic difficulty associated with bipolar disorder.

The study will include 436 patients and take place in 4 expert clinical centres: Hospital Clínic de Barcelona, Spain with Prof. Eduard Vieta as Principal Investigator; Center of Psychiatry of the Copenhagen region, Denmark with Prof. Lars Kessing; GHU Paris Psychiatrie & Neurosciences, France with Prof. Chantal Henry and Parc Sanitari Sant Joan de Déu, Spain with Dr. Josep Maria Haro as investigators, respectively. This first patient inclusion marks the start of the study that will take 2 years in total.

The study is partially funded by the EIT Health (European Institute of Innovation and Technology for Health), as part of the EDIT-B project consortium, named after the test. Launched in March, this public-private partnership brings together ALCEDIAG, the aforementioned 4 expert clinical centers, as well as ProductLife Group and Synlab Italy.

"In a first clinical discovery study, a panel of RNA blood biomarkers in patients with a major depressive episode has been identified, allowing to differentiate bipolar disorder from MDD (unipolar depression). These biomarkers are based on RNA modifications, namely RNA editing, that could be identified using molecular biology, NGS and artificial intelligence. We now want to validate these results in a multi-center study”, Says Dinah Weissmann Deputy CEO of ALCEDIAG.

"Mental illnesses are pathologies of the brain that cause almost 10,000 suicides per year in France alone, and the numbers are much higher on a global scale. We must be able to improve the care of patients through personalized diagnosis based on biomarkers", said Prof. Chantal Henry, psychiatrist and study investigator at GHU Paris Psychiatrie & Neurosciences, where the first patient was recruited. “I am very happy that we have recruited our first patient and are able to launch this validation study”.

About EDIT-B blood test

EDIT-B assay is a qualitative in vitro diagnostic system. It determines the RNA editing rate of a panel of biomarkers isolated from human peripheral blood samples using NGS and artificial intelligence.  The result , in conjunction with the standard diagnostic methods and clinical practice guidelines, supports the differential diagnosis between bipolar disorder and unipolar depression (major depressive disorder).

The EDIT-B blood test is based on ALCEDIAG’s proprietary and patented biomarkers and algorithms.

About ALCEDIAG

ALCEDIAG is an innovative diagnostics company focusing on mental health, developing a platform harnessing cutting-edge molecular biology and Artificial Intelligence to discover and utilize new proprietary RNA editing based biomarkers in clinical routine. ALCEDIAG is a subsidiary of ALCEN, an industrial diversified French group with a strong focus on innovation advancing societal challenges.

For more information visit: www.alcediag-alcen.com

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