SYNLAB Launches New Test to Differentiate Bipolar Disorder and Depression; Clinical Validation Shows High Accuracy Using Novel RNA Biomarkers

SYNLAB, a leading reference laboratory in Europe, is introducing a new diagnostic test for bipolar disorder known as myEDIT-B. The blood-based test is the world’s first broadly clinically marketed test for distinguishing between bipolar disorder and unipolar depression, and aims to improve diagnosis process for these mental health disorders. The development of myEDIT-B is the result of a collaboration between SYNLAB and diagnostics manufacturer Alcediag, conducted under the EU funding program EITHealth. This test is now available in Italy and through SYNLAB’s network in various countries.

myEDIT-B is a CE-IVD certified molecular test that utilizes RNA-editing biomarkers through RNA sequencing from a blood sample in the laboratory. The test utilizes the myEDIT-B algorithm which then assesses RNA editing profiles of genes associated with common mood disorders. The test provides clinically validated results within just 24 days.

In a research study validating the test, researchers utilized A-to-I RNA editing analysis to identify 646 variants (involving 366 genes) with differential editing between depressed patients and healthy volunteers in a discovery cohort of 57 participants. By applying stringent criteria and biological pathway analysis, eight genes were identified as potential biomarkers. These candidates were then tested in a validation cohort comprising 410 participants. A machine learning approach that combined these biomarkers effectively differentiated depressed patients (n = 267) from controls (n = 143) with a high accuracy of 0.930 (CI 95% [0.879–0.982]), along with a sensitivity of 84.0% and specificity of 87.1%. In the second phase of the study, the focus shifted to distinguishing between unipolar depression (n = 160) and BD (n = 95) within the group of depressed patients. Researchers identified a combination of six biomarkers that enabled a differential diagnosis of bipolar disorder with an impressive accuracy of 0.935, coupled with a high specificity (Sp = 84.6%) and sensitivity (Se = 90.9%).

Mental health disorders affect approximately 84 million people in Europe, which is roughly 17% of the population. Bipolar disorders are diagnosed in about 1.3% of the European population. The conventional process of diagnosing mood disorders is complex and often lengthy, with bipolar disorder diagnoses extending over several years. Research indicates an average of seven years until a confirmed diagnosis is reached with patients often undergoing a diagnostic and treatment odyssey. An accurate distinction between bipolar disorder and unipolar depression is particularly challenging but vital, as both conditions require very different treatments. Currently, about 50% of patients are initially misdiagnosed with unipolar depression. In people with bipolar disorder, SSRIs and other antidepressants carry a risk of bringing about mania and this misdiagnosis puts patients at risk of hospitalization, comorbidity, addiction, suicide, and a decreased quality of life.