Laguna Diagnostics Awarded Second U.S. Patent for Revolutionary Blood-Based Diagnostics for Mental Health

Strategic Insights -

Laguna Diagnostics, LLC, a pioneer in blood-based diagnostics for mental health, has been awarded its second U.S. patent for its breakthrough rapid blood tests that accurately diagnose and differentiate schizophrenia and bipolar disorder. The patented method represents the only rapid blood tests capable of diagnosing SZ or BD from psychiatrically normal individuals, offering results in 'Days, NOT Years(TM)'. The $3 billion market opportunity addresses a critical unmet need in mental health diagnosis, where schizophrenia and bipolar disorder affect millions of Americans and are notoriously difficult to distinguish clinically.

Key Takeaways:

  • Laguna Diagnostics' patented method differentiates between schizophrenia and bipolar disorder with over 90% accuracy, offering results in days rather than years.
  • The patented method comprises a four-step process, including precision biomarker signatures determining the mRNA gene expression level of 18 genes, and diagnosing patients as SZ, BD, or NC based on results from the blood sample.
  • The primary endpoint is the area under the curve (AUC) of the receiver operating characteristic (ROC), giving the sensitivity and specificity derived from transcript abundance, with exceptionally strong diagnostic performance, including AUCs of 0.995.
  • Laguna's breakthrough tests have the potential to diagnose and differentiate other mental illnesses, truly revolutionizing the field of psychiatry and giving physicians tools they have never had before.
  • The company's intellectual property portfolio strengthens with this second patent, building on their first patent in 2023 and the 2018 peer-reviewed publication in Molecular Neuropsychiatry.
  • Laguna's pioneering work has been supported by two earlier SBIR grants from the National Institute of Mental Health and ongoing collaborations with the University of California--Irvine, University of Iowa, and Innovative Analytics.

Statistics:

  • 50% misdiagnosis rate of schizophrenia
  • 70% misdiagnosis rate of bipolar disorder
  • 0.995 AUC of the receiver operating characteristic (ROC) for diagnostic performance
  • 90% accuracy in differentiating between schizophrenia and bipolar disorder
  • 2 million patients annually affected by schizophrenia and bipolar disorder in the US
  • $3 billion market opportunity for revolutionary blood-based diagnostics for mental health

Sources:

  • Laguna Diagnostics, LLC
  • U.S. Patent No. 12,404,553 B2: "Biomarkers for Bipolar Disorder and Schizophrenia" (October 1, 2025)
  • U.S. Patent No. 11,713,486 B2: "Blood-Based Diagnostic Method for Differentiating Bipolar Disorder, Schizophrenia and Psychiatrically Normal Controls" (2023)
  • Molecular Neuropsychiatry (2018)
  • National Institute of Mental Health