In Europe, where he estimates that 2,3 % of the population would be affected by bipolar disorder (1). A figure that is largely underestimated, since on average 8 to 10 years pass between the appearance of symptoms and diagnosis (2).
To date, the diagnosis of bipolar disorders is based solely on a clinical psychiatric examination of the patient, carried out by a specialist doctor using questionnaires and various validated scales (3).
In order to significantly reduce the time to diagnosis of bipolar disorders, ALCEDIAG et SYNLAB join forces and announce, on the occasion of the 31st EPA Congress, the provision ofEDIT-B™, the first blood test in vitro CE marked, intended to differentiate the disorder bipolar major depression.
Clinically validated in depressed adults and CE marked, EDIT-B™ offers remarkable performance with excellent sensitivity and specificity, greater than 80%.
The objective is to help specialist doctors quickly make a precise differential diagnosis and thus significantly reduce the diagnostic delay, from several years to a few days. Patient care can then be optimized: implementation of appropriate treatment, reduction of comorbidities and improvement of quality of life (personal and professional spheres).
This biological tool complements the various existing clinical scales, the interpretation of which is empirical. Technically, EDIT-B™ measures the RNA editing change of specific markers in patients' blood. ALCEDIAG, behind the development of this test and its clinical and regulatory validation, uses cutting-edge next-generation sequencing (NGS) technology coupled with proprietary algorithms developed using artificial intelligence (AI).
Concretely, what does the availability of the EDIT-B™ test mean?
The patient goes to a psychiatrist. In order to make a precise diagnosis (depression or bipolar disorder), the practitioner prescribes EDIT-B™. The patient then goes to an accredited medical and biological analysis laboratory of the SYNLAB network who takes a blood sample, and carries out the sequencing of the patient's blood sample. SYNLAB uploads the data to a secure platform developed and provided by ALCEDIAG, which uses an algorithm that determines whether the patient has depression or bipolar disorder and sends the results back to the practitioner.
EDIT-B™ is now available in Italy, and will soon be made available to practitioners and patients in France and in Suisse during the year 2023, as well as gradually in other countries where SYNLAB is established (26 countries in total in Europe).
ABOUT ALCEDIAG
ALCEDIAG is an innovative diagnostic company, with a primary focus on mental health, which develops
a platform leveraging cutting-edge molecular biology and artificial intelligence to discover and use
new exclusive biomarkers based on RNA editing in the clinic. ALCEDIAG is a subsidiary of ALCEN,
a diversified French industrial group strongly focused on innovation in the service of societal challenges.
For further information, please visit www.alcediag-alcen.com
References
(1) Merikangas KR, Jin R, He JP, Kessler RC, Lee S, Sampson NA, et al. Prevalence and correlates of bipolar
spectrum disorder in the world mental health survey initiative. Arch Gen Psychiatry 2011;68(3):241- 51.
(2) High Authority of Health. Bipolar disorders: identification and diagnosis as a first resort. June 2014.
(3) https://www.psychiatry.org/psychiatrists/practice/dsm/educational-resources/dsm-5-fact-sheets