Laguna Diagnostics LLC has received Breakthrough Device Designation from U.S. Food and Drug Administration for its mRNA Gene Biomarker Test, a novel blood-based diagnostic designed to help differentiate between schizophrenia and bipolar I disorder in symptomatic patients.

Schizophrenia and bipolar disorder affect millions in the United States, yet diagnosis today relies largely on subjective clinical assessments, prolonged observation, and patient-reported symptoms. Misdiagnosis rates are estimated to exceed 50%, with definitive diagnosis often taking one to three years or longer.

The FDA’s designation underscores the potential of Laguna’s technology to address a long-standing challenge in psychiatry, where delayed or uncertain diagnoses are common due to the absence of objective diagnostic tools.

Laguna’s test analyses mRNA biomarker signatures from a simple venous blood sample to generate an objective probability score, helping clinicians distinguish between schizophrenia and bipolar I disorder. It is intended to complement clinical evaluation and other patient data, rather than function as a standalone diagnostic.

As part of the Breakthrough Device process, the company reanalysed its pivotal study using a locked diagnostic algorithm and FDA-recommended modifications. The updated results showed 96.7% sensitivity for schizophrenia, 100% specificity for bipolar I disorder, and an overall accuracy of 98.3%, indicating a strong biological signal and high potential clinical relevance.

Schizophrenia and bipolar I disorder are serious, often debilitating conditions, and differentiating between them remains complex. More objective and timely diagnostic tools could enable earlier intervention and better-informed clinical decisions, easing the burden on patients and caregivers.

The FDA’s Breakthrough Devices Program is designed to accelerate the development and review of technologies that may offer improved diagnosis or treatment for life-threatening or debilitating conditions. While the designation allows for closer collaboration with the FDA and expedited review, it does not alter regulatory standards or guarantee eventual approval.

Laguna Diagnostics is continuing clinical validation studies while working closely with the FDA under the program.

Commenting on the milestone, Terry W. Osborn, PhD, MBA, Co-Founder and CEO of Laguna Diagnostics, said, “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. We believe our approach has the potential to support clinicians in making more informed diagnostic decisions and, ultimately, improve outcomes for patients.”