SYNLAB, a leading network of medical biology laboratories, in partnership with ALCEDIAG, has introduced myEDIT-B in France, the first blood test aimed at assisting in the diagnosis of mental health conditions by distinguishing between bipolar disorders and depression in adults. The test, which “surpasses 80 percent sensitivity and specificity” according to its founders, could enhance the management of bipolar disorders, reduce diagnostic timelines and ultimately improve patient outcomes.
Set to be available from April 2024 in SYNLAB France’s laboratory network, the myEDIT-B test significantly reduces the diagnosis time for bipolar disorders from an average of 8 years to less than a month. Clinically validated by ALCEDIAG, the test relies on next-generation sequencing (NGS) of RNA in the blood, coupled with an algorithm based on artificial intelligence, boasting performance rates exceeding 80%.
The urgency for quicker and more accurate differential diagnosis of bipolar disorders to improve disease prognosis and patient quality of life cannot be overstated. Bipolar disorders are psychiatric conditions characterized by alternating manic or hypomanic phases, known as “up” phases, and depressive phases, known as “down” phases.
Studies indicate an average diagnostic period of 8 to 10 years, with some cases extending beyond 15 years before confirmation. Currently, diagnosis relies on psychiatric clinical examination, often leading to misdiagnosis, particularly with Major Depressive Episodes (depression), whose symptoms mirror those of depressive phases in bipolar disorders.
Depression and bipolar disorders are distinct illnesses requiring different treatment approaches. Early and accurate diagnosis is pivotal, as bipolar disorders often lead to severe consequences such as social isolation, academic or professional challenges, addictions, risky behaviors, sleep disturbances and, alarmingly, suicidal tendencies, with 1 in 2 bipolar patients attempting suicide at least once in their lifetime.
Precision Medicine in Psychiatry
myEDIT-B offers a new ray of hope for patients and an advancement in precision medicine in psychiatry. Early and precise diagnosis, facilitating appropriate treatment, is paramount to averting adverse health and quality of life outcomes for patients and their families.
SYNLAB and ALCEDIAG’s myEDIT-B, as the first clinically validated diagnostic aid, complements existing diagnostic tools and criteria. The test targets patients aged 18 and above currently treated for Major Depressive Episodes, moderate or severe, and must be prescribed by a psychiatrist.
The prescription must be accompanied by clinical information and patient consent, with results delivered within 4 weeks to the prescribing psychiatrist for confirmation during consultation.
Key features of myEDIT-B include its clinical validation on hundreds of patients, superior sensitivity and specificity exceeding 80%, simplicity with a blood-based test, rapid turnaround time and certification as a qualitative in vitro medical device (CE-IVD).
Clinical Trials in France and Switzerland
Clinical studies have demonstrated its efficacy across diverse patient cohorts, with ongoing efforts to demonstrate its clinical utility and medico-economic impact for reimbursement.
Technically, myEDIT-B utilizes RNA editing markers measured through NGS technology, augmented by ALCEDIAG’s AI-driven algorithm. Eight specific RNA sequences were identified for analysis, considering multifactorial data such as age, gender, treatments and addictions. Clinical trials conducted in France and Switzerland have yielded consistent performance rates exceeding 80%, leading to CE-IVD marking, a global first.
Dr. Florian Scherrer, SYNLAB France’s Medical Director, said:
“Integrating diagnostic innovation is an ongoing process at SYNLAB. With the myEDIT-B test, we are particularly delighted to introduce a unique diagnostic aid in mental health, thereby fostering new professional relationships with psychiatrists and psychiatric care facilities, for the greatest benefit of patients.
The availability of the myEDIT-B test marks a significant breakthrough in the field of psychiatry.”
Alexandra Prieux, CEO of ALCEDIAG, commented:
“Our goal with myEDIT-B is to assist psychiatrists in reducing the diagnostic time for bipolar disorders from several years to a few weeks (initially) and ultimately, we hope, to just a few days.
Its availability for routine clinical use through our collaboration with the SYNLAB France medical biology group is a key step for the ALCEDIAG team.
We see it as a significant move towards achieving our mission: to contribute to improving the health and quality of life of patients and their families through precision psychiatry, by developing innovative diagnostic tests based on neuroscience, advanced biology, and artificial intelligence.”
