Laguna Diagnostics’ blood-based mRNA Gene Biomarker test for differentiating schizophrenia from bipolar I received FDA Breakthrough Device designation. The test, intended for use alongside clinical assessment and other patient information, generates a probability score from venous blood mRNA biomarker signatures. In the company’s pivotal study, Laguna reported 96.7% sensitivity for schizophrenia, 100% specificity for bipolar I, and 98.3% overall accuracy. Breakthrough designation can support more intensive FDA interaction and may accelerate development timelines when evidence requirements align. Laguna said it is pursuing additional clinical validation studies and continued engagement with the FDA. The company framed the program as aimed at adding objective, biology-based decision support in psychiatric care. For the diagnostics market, the designation highlights growing momentum for molecular assays in psychiatry and may increase attention on payer and clinician adoption pathways for biomarker-guided diagnosis.