Blood Test Receives FDA Breakthrough Status to Differentiate Schizophrenia and Bipolar Disorder

Current diagnostic pathways rely heavily on subjective assessments and extended observation, contributing to delays and uncertainty. Misdiagnosis rates may exceed 50%, and establishing a definitive diagnosis can take one to three years in many cases. A new blood-based mRNA gene biomarker test has now received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation to support more accurate differentiation between schizophrenia and bipolar I disorder.

The mRNA Gene Biomarker Test from Laguna Diagnostics, LLC (Irvine, CA, USA) is intended for use in symptomatic patients to support clinicians when the differential includes both schizophrenia and bipolar I disorder. The assay analyzes mRNA biomarker signatures from a standard venous blood sample and generates an objective probability score to help distinguish schizophrenia from bipolar I disorder. It is designed to be used alongside routine clinical assessment and other patient information and is not a standalone diagnostic.

The U.S. FDA granted Breakthrough Device Designation to the test, a program intended to speed development and review of technologies that may offer more effective diagnosis or treatment of life‑threatening or irreversibly debilitating conditions. The designation enables enhanced interaction with the agency and prioritized review as development proceeds. Laguna reports it is advancing the technology through further clinical validation studies, with ongoing FDA engagement under the program.

As part of the Breakthrough Device process, the company reanalyzed pivotal study data using FDA‑suggested modifications and a locked diagnostic algorithm. In that analysis, the test achieved 96.7% sensitivity for schizophrenia, 100% specificity for bipolar I disorder, and 98.3% overall accuracy. These findings demonstrated evidence of a highly discriminative biological signal supporting potential clinical relevance when the differential diagnosis includes both conditions.

“This designation is an important milestone in our mission to bring objective, biology-based, blood-based mRNA biomarker tools with a strong biological rationale into psychiatric care,” said Terry W. Osborn, PhD, MBA, Co-Founder and Chief Executive Officer of Laguna Diagnostics. "We believe our approach has the potential to support clinicians in making more informed diagnostic decisions and, ultimately, improve outcomes for patients."

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