About Us

Laguna Diagnostics develops proprietary blood-based RNA gene biomarker tests for diagnosing and differentiating mental and psychiatric disorders. Our initial products, protected under a U.S. patent, will diagnose and differentiate schizophrenia (SZ) and bipolar disorder (BD) from individuals without a psychiatric disorder, fulfilling a critical unmet healthcare need. Current diagnostic methods rely heavily on patient-reported symptoms and clinical observations by psychiatrists, typically over Years. Our disruptive, rapid quantitative blood RNA gene test results are returned to the ordering physician within 'Days, NOT Years™'.

Market — Our initial marketing strategy targets mental health and general medicine healthcare providers: psychiatrists, clinical psychologists, and primary care physicians. Another significant target segment in the marketing plan consists of nationwide early intervention Coordinated Specialty Care (CSC) treatment centers for individuals with psychosis spectrum symptoms and first-episode psychosis (FEP). Our tests emphasize early detection in undiagnosed and misdiagnosed patients to reduce the diagnostic odyssey from Years to Days. The estimated potential market size for our quantitative blood-based RNA gene biomarker tests exceeds $3.3 billion, with over 2.2 million potentially undiagnosed and misdiagnosed schizophrenia (SZ) and bipolar disorder (BD) patients annually. We used $1,500 per test for our market size calculations, which projects the available market at over $3.3 billion annually.

We seek initial seed funding to launch an extensive comfirmatory validation clinical trial study for FDA approval and commence commercial operations.

Our initial products, protected under a U.S. patent, will diagnose and differentiate schizophrenia (SZ) and bipolar disorder (BD) from individuals without a psychiatric disorder, fulfilling a critical unmet healthcare need.

Differential Advantages: Our differential advantages drive demand for a reliable diagnostic tool, which is substantial:

1. Current diagnostic methods rely heavily on patient-reported symptoms and clinical observations by psychiatrists, typically over 1 to 3 years. Our disruptive, rapid quantitative blood test results are returned to the ordering physician within 'Days, NOT Years™'.
2. Research shows that ~40% of patients with severe psychiatric disorders were initially misdiagnosed, with SZ being misdiagnosed in ~50% of cases and BD in ~70%.
3. There is a significant challenge in diagnosing youth and young adults who may exhibit unreported symptoms or early signs of psychosis months or even years before their FEP.
5. Delay by incorrect diagnoses can lead to inappropriate treatment, thus not effectively managing the patient’s symptoms and causing disorders to worsen to a treatment-resistant state. Also, the lag in diagnoses and treatment is associated with an increase in the suicide rate.

The estimated potential market size for our quantitative blood-based RNA gene biomarker tests exceeds $3.3 billion, with over 2.2 million potentially undiagnosed and misdiagnosed schizophrenia (SZ) and bipolar disorder (BD) patients annually.

Pivotal Clinical Trial — Our innovative approach has identified stable trait, blood-based RNA gene biomarkers for lifelong psychiatric disorders that have utility in undiagnosed and misdiagnosed patients. Pioneering work was done at the University of California, Irvine, and the University of Iowa with initial support from the National Institute of Mental Health (NIMH) via Small Business Innovative Research (SBIR) grants. Our breakthrough clinical trial was conducted with 90 subjects at three-time points and demonstrated that our 20 RNA gene panel diagnosed schizophrenia and bipolar disorder with high selectivity and high sensitivity (both over 95% and accuracy 92%), plus it effectively differentiated between SZ and BD patients.

Potential New Drug Market — Young people experiencing first-time psychosis in the U.S. typically have behavioral changes and psychosis spectrum symptoms for more than a year before receiving a diagnosis (RAISE Study-NIMH). As part of our validation clinical trial study, we are designing a protocol to test that our methodology allows for the objective diagnoses of SZ and BD with the potential to detect these conditions one to two years before a first psychotic episode (potential new drug market). Our proprietary rapid blood tests offer fast and more accurate diagnoses, enabling earlier intervention and reducing costs, leading to improved quality of life for patients. Our test results are generally returned rapidly to the ordering physician, usually within days. Research has shown that the earlier these psychiatric disorders are diagnosed and treated, the better the patient outcome. Early detection of a mental disorder also enables rapid interventions, especially in younger populations, with significant potential for benefits to the individual, family, and society.

We are seeking one or more partners in the biopharmaceutical industry who are interested in growing the market size and their market share by using our methods as companion diagnostics in developing therapeutics for affected patients.

Schizophrenia and Bipolar Disorder are chronic, severe, and disabling brain disorders with no adequate treatment for all patients. These disorders have multiple comorbidities, resulting in life-changing, earlier death, and productivity loss. Schizophrenia impacts 0.25% (677,500) to 0.64% (1,734,400), and bipolar disorder affects an estimated 2.8% (7,588,000) of the U.S. population respectively (NIMH). In the U.S., the annual healthcare cost (direct, indirect, plus non-healthcare) for schizophrenia is estimated to be $343 billion, and bipolar disorder is over $195 billion.

The Intellectual Property related to the methodology led to a U.S. landmark patent issued on August 1, 2023 (U.S. 11,713,486) and expires on Dec 24, 2039. Another patent application is pending and being examined by the U.S. Patent Office. Additional patent applications are pending.

Published in Molecular Neuropsychiatry. Our clinical tests and pivotal clinical trial were based on original work and were published in Molecular Neuropsychiatry in 2018. – Vawter MP, Philibert R, Rollins B, Ruppel PL, Osborn TW. Exon Array Biomarkers for the Differential Diagnosis of Schizophrenia and Bipolar Disorder. Mol Neuropsychiatry. 2018;3(4):197-213. Epub 2018/06/12. doi: 10.1159/000485800. PubMed PMID: 29888231; PubMed Central PMCID: PMCPMC5981774.