Laguna Diagnostics has secured a major regulatory milestone after the US FDA granted Breakthrough Device Designation to its mRNA Gene Biomarker Test, a blood-based assay to diagnose schizophrenia and bipolar I disorder in symptomatic patients.

 

The move puts a spotlight on one of psychiatry’s most persistent clinical challenges: misdiagnosis and delay. 

 

Laguna’s approach attempts to shift that paradigm. The company’s test analyzes mRNA biomarker signatures from a standard venous blood sample to generate an objective probability score designed to help distinguish between schizophrenia and bipolar I disorder. 

 

It is intended to complement—not replace—clinical judgment and other diagnostic inputs.

As part of the FDA Breakthrough Device process, Laguna was required to reanalyze pivotal study data using a locked diagnostic algorithm and FDA-suggested modifications. 

 

The results reported 96.7% sensitivity for schizophrenia, 100% specificity for bipolar I disorder, and 98.3% overall accuracy. These findings, according to the company, indicate a highly discriminative biological signal with potential clinical utility in difficult differential cases.

 

The Breakthrough Device Designation is reserved for technologies that may offer more effective diagnosis or treatment for serious or life-threatening 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, 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.”

 

Laguna emphasized that the test is still undergoing further clinical validation and remains under active development within the FDA Breakthrough Device program.

 

Schizophrenia and bipolar I disorder remain among the most complex psychiatric conditions to diagnose early and accurately. Advocates for improved diagnostics argue that earlier, more objective tools could reduce patient uncertainty, shorten time to treatment, and ease long-standing burdens on families and healthcare systems.

 

Laguna Diagnostics is currently advancing additional studies and regulatory engagement while pursuing funding to support CAP/CLIA validation, expanded clinical trials, and operational scaling.