FDA Grants Breakthrough Device Designation To Laguna Diagnostics For Blood Test To Differentiate Schizophrenia & Bipolar I Disorder

Laguna Diagnostics, LLC announced that the U.S. Food and Drug Administration (FDA) 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 people. Laguna's test uses mRNA biomarker signatures derived from a simple venous blood sample to generate an objective probability score that may help distinguish between schizophrenia and bipolar I disorder. The test is intended for use in conjunction with clinical assessment and other consumer information; it is not a standalone diagnostic.

Schizophrenia and bipolar disorder . . .