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

Laguna Diagnostics, LLC received U.S. Food and Drug Administration Breakthrough Device Designation for a blood test that helps distinguish Schizophrenia from Bipolar I disorder.

The test uses mRNA biomarkers to provide an objective score, showing high accuracy (~98%), and could significantly reduce misdiagnosis and speed up diagnosis, though it’s still under review and meant to support—not replace—clinicians.