Patent Issued for Rapid Blood Tests to Differentiate Schizophrenia and Bipolar Disorder

The United States Patent and Trademark Office has issued patent number 12,404,553 B2 for Laguna Diagnostics’ breakthrough rapid blood tests that accurately diagnose and differentiate schizophrenia and bipolar disorder.¹ The patented method represents the only rapid blood tests capable of diagnosing schizophrenia or bipolar disorder from psychiatrically normal individuals.

This is the second patent for Laguna, which builds upon their first patent from 2023 (US Patent No. 11,713,486 B2) and the 2018 peer-reviewed publication in Molecular Neuropsychiatry that first reported the discovery of 18-gene biomarker panels capable of differentiating schizophrenia, bipolar disorder, and healthy controls with 88% to 96% accuracy.²

"This second patent further establishes Laguna Diagnostics as the leader in objective, blood-based diagnostics for mental health," said Terry W. Osborn, PhD, MBA, cofounder and chief executive officer of Laguna. "Our technology not only differentiates between bipolar disorder and schizophrenia affecting ~2 million patients annually and representing a ~$3 billion SAM but also has broad potential to diagnose and differentiate other mental illnesses, truly revolutionizing the field of psychiatry and giving physicians tools they have never had before."

To help distinguish these 2 disorders, which are often misdiagnosed due to overlapping symptomology, Laguna's patented blood tests aim to deliver objective results and enable earlier interventions, which could in turn improve patient outcomes and reduce the significant costs associated with delayed or inaccurate diagnoses.

One patient’s mother shared her thoughts: "How different life would have been for my 12-year-old daughter and our family if there had been a blood test that diagnosed her with bipolar disorder. We faced nearly 30 years of uncertainty, enduring repeated misdiagnoses and experimenting with various medications that frequently worsened her symptoms. She suffered, and so did our family. These tests will be life-changing for patients and their families!"¹

The patented method consists of several steps:

1. Precision biomarker signatures determining the mRNA gene expression level of 18 genes.
2. Continuation in a 4-step process.
3. Calculating the probability that a sample comes from a patient with or without schizophrenia or bipolar disorder.
4. Diagnosing the patient with schizophrenia, bipolar disorder, or neither based on results from the blood sample compared with a predetermined cut-off.

The primary endpoint is the area under the curve (AUC) of the receiver operating characteristic, giving the sensitivity and specificity derived from transcript abundance. Diagnostic performance was exceptionally strong, with AUCs of 0.995 (NC vs. BD+SZ), 0.967 (NC vs. SZ), 0.987 (NC vs. BD), and 0.996 (SZ vs. BD).

“There is a serious need for ‘objective’ clinical laboratory tests for an early diagnosis of these mental disorders, since today these disorders may typically take months or even years to reach a diagnosis and for patients to receive effective treatment. The lag in treatment is associated with an increase in suicide rates and recurrent episodes of psychosis and mood dysregulation,” said the authors of the 2018 study. “Biomarker signatures could lead to faster and more accurate diagnoses, reducing the duration of untreated psychosis, suicidality, and cognitive decline and adding to an understanding of the shared and unique pathophysiologies of each disorder.”²

References

1. Laguna Diagnostics awarded second U.S. patent for rapid blood tests to differentiate schizophrenia and bipolar disorder, expanding IP portfolio in $3B market. News release. October 1, 2025. Accessed October 23, 2025. https://www.prnewswire.com/news-releases/laguna-diagnostics-awarded-second-us-patent-for-rapid-blood-tests-to-differentiate-schizophrenia-and-bipolar-disorder-expanding-ip-portfolio-in-3b-market-302571889.html

2. Vawter MP, Philibert R, Rollins B, et al. Exon array biomarkers for the differential diagnosis of schizophrenia and bipolar disorder. Mol Neuropsychiatry. 2018;3(4):197-213.