Laguna Diagnostics’ blood-based mRNA Gene Biomarker test for schizophrenia and bipolar I disorder received FDA Breakthrough Device designation. The assay is designed to differentiate schizophrenia from bipolar I in symptomatic patients, using mRNA biomarker signatures from a venous blood draw to produce a probability score. The company emphasized the test is intended for use alongside clinical assessment and other information, and not as a standalone diagnostic. In a pivotal study, Laguna reported 96.7% sensitivity for schizophrenia, 100% specificity for bipolar I, and 98.3% overall accuracy. The designation supports continued clinical validation and interactions with FDA as Laguna moves toward further evidence generation.