U.S. FDA Grants Breakthrough Device Designation to Laguna Diagnostics' mRNA Gene Biomarker Test to Aid in Differentiation of Schizophrenia and Bipolar I Disorder

IRVINE, Calif., April 28, 2026 /PRNewswire/ -- Laguna Diagnostics, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company's mRNA Gene Biomarker Test, a novel blood-based test designed to aid in the differentiation of...

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