Laguna Diagnostics mRNA Gene Biomarker Test Gets FDA Breakthrough Device Status

Laguna Diagnostics has earned Breakthrough Device designation from the U.S. FDA for its mRNA Gene Biomarker Test. The test is a novel, blood-based way to aid differentiation of schizophrenia and bipolar I disorder in symptomatic patients.

Schizophrenia and bipolar I disorder are serious, often debilitating psychiatric conditions that affect millions of people in the United States. It is sometimes difficult to differentiate between the two. Diagnostic timelines can stretch from months to years, and research has suggested misdiagnosis rates exceed 50%.

How mRNA Biomarker Can Help

Current diagnostic methods include subjective assessments, long-term observation, and self-reporting by patients. Laguna says the mRNA biomarker signatures gathered from its test generate an objective probability score to help differentiation.

FDA’s Breakthrough Devices program intends to speed development and review of technologies that may offer more effective diagnoses. Commonly, these technologies deal with life-threatening or “irreversibly debilitating” conditions.

FDA asked Laguna to analyze pivotal study data, with certain conditions. The results yielded 96.7% sensitivity for schizophrenia, 100% for bipolar I disorder, and 98.3% overall accuracy.

Test Aligns With Laguna Mission

Laguna Diagnostics focuses on bringing rapid, objective, blood- and biology-based mRNA biomarker tests into psychiatric settings. Acknowledging that, co-founder and CEO Terry Osborn, PhD, called this an “important milestone in our mission.”

“[It has] potential to support clinicians in making more informed diagnostic decisions and, ultimately, improve outcomes for patients,” Osborn said.

What FDA is Offering Going Forward

As part of the Breakthrough Device designation, Laguna receives enhanced interaction opportunities with the FDA, plus prioritized review. The FDA decision does not, however, circumvent standards for safety and effectiveness—nor guarantee marketing approval.

Laguna Diagnostics is currently raising money to support validation, strategic hiring, and launching clinical trials with FDA study design support.

The mRNA Gene Biomarker Test has been designed to be used in combination with clinical assessment and other patient information. It is not intended as a standalone diagnosis.