Mental health diagnostics have been in crisis for some time now due to increasing patient loads, lack of definitive diagnostics and adverse societal impact. This has created a huge burden on healthcare systems along with uncertainty for individuals, particularly young people who begin to exhibit symptoms in their early teens, causing anguish for families, often for many years. Recent advances in mRNA analytics and automation, along with scalable solutions, have led to improved tests that detect and differentiate schizophrenia from bipolar disorder with higher accuracy than traditional psychiatric methods. Results are reported in days, not months or years, from a simple blood test. Recently, the US FDA assigned “Breakthrough Device Designation” to a methodology in this area in recognition of its potential to change the way these two diseases are diagnosed. The methods being developed have the potential to change how psychiatry is practiced more in the next ten years than it has been practiced in the past 100 years.

Schizophrenia (SZ) and bipolar disorder (BD) are severe psychiatric disorders associated with functional impairment, substantial morbidity and reduced life expectancy. SZ is characterised by psychiatric symptoms such as delusions, hallucinations and cognitive deficits that manifest as people seemingly lose touch with reality. It is usually first diagnosed between the ages of 16 and 30 following an initial psychotic episode. SZ affects millions of people with a global prevalence of 0.33%-0.75%. BD is a chronic mood disorder characterised by episodes of mania alternating with depressive episodes.¹ BD affects more than 1% of the world’s population and ranks second in terms of its most significant impact for lost workdays. The clinical presentation of these disorders frequently overlaps during acute episodes. Psychosis is present in 20% to 50% of patients with acute bipolar mania and depressive symptoms occur in both conditions ² First-episode psychosis patients may present with overlapping symptoms making initial differentiation particularly challenging.³ This overlap is especially pronounced in young adults with first presenting episodes, where distinguishing features may not yet fully show.

Despite advances in understanding disease biology, diagnosis and differentiation of SZ and BD remain based almost exclusively on clinical and symptom-based criteria rather than objective biological measurements. The lack of quantitative tools to aid in early detection and differentiation between SZ and BD represents a significant unmet need for the mental health community. Misdiagnosis or delayed diagnosis can result in inappropriate treatments, including exposure to medications that may be ineffective or cause adverse effects, as well as delay of appropriate therapies. Accurate differentiation between SZ and BD is essential, as treatment selection, dosing strategies and risk–benefit profiles differ substantially. Misdiagnosis can lead to delayed or inappropriate therapy and increased hospitalisation, leading to poorer long-term outcomes.