The mRNA-based test aims to provide objective data to help clinicians distinguish between psychiatric conditions that often share symptoms.
The US Food and Drug Administration (FDA) granted Breakthrough Device Designation to an mRNA gene biomarker test from Laguna Diagnostics designed to aid in differentiating schizophrenia and bipolar I disorder in symptomatic patients.
Currently, diagnosing these psychiatric conditions relies on subjective assessments, patient self-reporting, and long-term observation. Research indicates misdiagnosis rates may exceed 50%, with diagnostic timelines often requiring one to three years to reach a conclusion, according to Laguna Diagnostics.
The new test utilizes mRNA biomarker signatures from a venous blood sample to generate an objective probability score. This score is intended for use alongside clinical assessments and other patient information rather than as a standalone diagnostic tool.
“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,” says Terry W Osborn, PhD, MBA, co-founder and chief executive officer of Laguna Diagnostics, in a release. “We believe our approach has the potential to support clinicians in making more informed diagnostic decisions and, ultimately, improve outcomes for patients.”
Clinical Data and Accuracy
In data submitted for the FDA Breakthrough Device process, the test’s diagnostic algorithm demonstrated 96.7% sensitivity for schizophrenia and 100% specificity for bipolar I disorder. The overall accuracy was reported at 98.3%. These results suggest a discriminative biological signal that may provide clinical insights when a differential diagnosis includes both conditions.
The company’s precision psychiatry platform is designed to deliver data-driven insights to support clinical decision-making. By providing results in days rather than years, the test addresses a significant unmet need in the accurate and timely diagnosis of severe mental illnesses.
The Breakthrough Device Program
The FDA Breakthrough Devices Program is intended to accelerate the development and review of technologies that provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating conditions. While the designation provides prioritized review and enhanced interaction with the FDA, it does not change the agency’s standards for safety and effectiveness or guarantee marketing approval.
Laguna Diagnostics is currently moving the technology through further clinical validation studies. The company is also seeking funding to support CAP/CLIA validation, strategic hires, and the initiation of clinical validation trials with FDA study design support.
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