Laguna Diagnostics said the FDA granted breakthrough device designation to its mRNA Gene Biomarker test aimed at differentiating schizophrenia from bipolar I disorder in symptomatic patients. The blood-based assay generates an objective probability score from venous blood mRNA signatures. The company reported strong performance metrics in a pivotal study, including 96.7% sensitivity for schizophrenia and 98.3% overall accuracy, with 100% specificity for bipolar I disorder. Laguna emphasized the test is intended to be used alongside clinical assessment rather than as a standalone diagnostic. The designation is a pathway milestone that can accelerate further clinical validation and regulatory discussions. The company said it is continuing studies and engaging with FDA as it works toward broader adoption. If successful in confirmatory settings, biology-driven psychiatry diagnostics could reduce diagnostic uncertainty and improve treatment targeting for patients where symptom overlap is common.