On Apr. 28, 2026, Laguna Diagnostics 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%, and current methods often require 1–3+ years to reach a conclusion.

The designation highlights the potential of Laguna’s approach to address a longstanding challenge in psychiatry, where diagnosis often relies on subjective assessment, extended observation, and patient-reported symptoms—frequently resulting in delayed or uncertain diagnoses.

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 patient information and is not a standalone diagnostic.

As part of the FDA Breakthrough Device process, Laguna was asked to reanalyze its pivotal study data with suggested modifications and a locked diagnostic algorithm. The results demonstrated 96.7% sensitivity for schizophrenia, 100% specificity for bipolar I disorder, and 98.3% overall accuracy. These findings indicate a highly discriminative biological signal and support the test’s potential to provide clinically meaningful insights in cases where the differential diagnosis includes both conditions. With the test demonstrating high levels of sensitivity and specificity, it further supporting its potential clinical utility.