Laguna Diagnostics received FDA Breakthrough Device designation for its mRNA Gene Biomarker test intended to help differentiate schizophrenia from bipolar I disorder in symptomatic patients. The blood-based assay generates an objective probability score from venous samples and is designed for use alongside clinical evaluation rather than as a standalone diagnostic. In a pivotal study, Laguna reported 96.7% sensitivity for schizophrenia, 100% specificity for bipolar I disorder, and 98.3% overall accuracy. The company said it is continuing clinical validation studies and ongoing engagement with the FDA to support further development steps. The Breakthrough designation can accelerate development timelines for clinically unmet diagnostic needs in psychiatry by signaling the agency sees potential for meaningful improvement in diagnostic decision-making.