ALCEDIAG and SYNLAB join forces in Europe to fight diagnostic delay of bipolar disorder with the EDIT-B™ test

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ALCEDIAG , SYNLAB

27 Mar, 2023, 09:00 GMT

PARIS and MILAN , March 27, 2023 /PRNewswire/ --

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EDIT-B: First-in-class CE-marked blood test differentiating bipolar disorder from depression

  • 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 31st 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).

Press Contact ALCEDIAG
AZAPHARM(Paris)
Merryl Marcout
mmarcout@azapharm.com

Press contact  SYNLAB
HAVAS PR (Milan)
Giovanna Giacalone
Giovanna.giacalone@havaspr.com  

About ALCEDIAG

ALCEDIAG is an innovative diagnostics company, focused on mental health, leveraging advanced molecular biology and artificial intelligence to discover and clinically validate the use of new proprietary biomarkers based on RNA editing. ALCEDIAG is a subsidiary of ALCEN, French industrial group with a strong focus on innovation to address societal challenges.

About SYNLAB

SYNLAB strives daily to put people and their health at the center, through responsibility, reliability and innovation, and has introduced in Italy a new "integrated" approach to medical prevention and health care in accordance with the highest European quality standards. Its aim is offering customers a solid and reliable basis for taking the best possible therapeutic decisions.

[1] Merikangas KR & al. Prevalence and correlates of bipolar spectrum disorder in the world mental health survey initiative. Arch Gen Psychiatry 2011;68(3):241- 51.
[2] HAS. June 2014
[3] Salvetat & al. A game changer for bipolar disorder diagnosis using RNA editing-based biomarkers. Transl.Psychiatry (2022) 12:182
[4] Directive 98-79-CE

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