Laguna Diagnostics said its mRNA Gene Biomarker blood test for differentiating schizophrenia from bipolar I disorder received FDA Breakthrough Device Designation. The assay is intended to generate a probability score using mRNA signatures from a venous blood sample, used alongside clinical assessment 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 advancing additional clinical validation work while continuing FDA engagement. The designation highlights the FDA’s interest in objective biomarker tools for psychiatric diagnosis, where differential accuracy can affect downstream treatment selection and patient outcomes.