U.S. FDA Grants Breakthrough Device Designation to Laguna Diagnostics’ mRNA Gene Biomarker Test to Aid in Differentiation of Schizophrenia and Bipolar I Disorder

IRVINE, CA, April 29, 2026 / Biotech Newswire / -- Laguna Diagnostics, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s mRNA Gene Biomarker Test, a novel blood-based test designed to aid in the differentiation of schizophrenia and bipolar I disorder in symptomatic patients. Schizophrenia and bipolar disorder affect millions of Americans, yet current diagnostic methods rely heavily on subjective assessments, long-term observation, and patient self-reporting. Research suggests misdiagnosis rates may exceed 50%(1), and current methods often require 1–3+ years to reach a conclusion. The designation highlights the potential of Laguna’s approach to ...