Laguna Diagnostics received FDA Breakthrough Device designation for its mRNA Gene Biomarker blood test designed to differentiate schizophrenia from bipolar I disorder. The test generates an objective probability score using mRNA biomarker signatures from venous blood. In the pivotal study reported by the company, the assay showed 96.7% sensitivity for schizophrenia, 100% specificity for bipolar I, and 98.3% overall accuracy. The company positioned the tool for use alongside clinical assessment rather than as a standalone diagnostic. Breakthrough designation can support faster development pathways for clinical validation and review, which matters in psychiatry where diagnostic ambiguity often delays the right treatment. For biotech and diagnostic developers, the focus is on how well biology-based classifiers translate into real-world workflows, including patient selection, reproducibility across sites, and regulatory endpoints for clinical utility.