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Laguna Diagnostics mRNA Gene Biomarker Test Gets FDA Breakthrough Device Status

It’s a novel, blood-based test to aid differentiation of schizophrenia and bipolar I disorder.

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By: Patrick Lavery

Content Marketing Editor

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...

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