Laguna Diagnostics
Laguna Diagnostics is a pre-revenue medical diagnostics company developing a blood-based mRNA biomarker test to objectively differentiate schizophrenia from bipolar I disorder for psychiatrists and healthcare systems.
- Company typePrivate
- Founded-
- HeadquartersIrvine, United States
- Headcount—
- GTM typeB2B
- OfferingServices
What Laguna Diagnostics does
Laguna Diagnostics is a pre-revenue medical diagnostics company developing blood-based mRNA biomarker tests to objectively distinguish between schizophrenia and bipolar I disorder in patients presenting with overlapping psychiatric symptoms. The company's lead product, the mRNA Gene Biomarker Test, is a single blood-based diagnostic that demonstrated 96.7% sensitivity for schizophrenia, 100% specificity for bipolar I disorder, and 98.3% overall accuracy in pivotal study data. The company is headquartered in Irvine, California, is structured as an LLC, and is operating in a pre-commercial development phase.
The test addresses an unmet need: current clinical diagnostic methods for these conditions rely on subjective assessment and exhibit misdiagnosis rates exceeding 50%, with diagnostic timelines of 1-3+ years. Laguna Diagnostics received FDA Breakthrough Device Designation in April 2026 and is advancing through further clinical validation studies under the Breakthrough Device program.
Once FDA clearance is obtained, the company plans to commercialize through an enterprise field sales motion targeting psychiatrists and mental health clinicians as the primary customer, with healthcare systems and psychiatric hospitals as secondary channel customers. Revenue mechanics are expected to involve one-time payments per diagnostic test sold to providers. The company is currently seeking additional funding for ongoing clinical validation and development, and no pricing, commercial partnerships, named customers, or distribution channels have been disclosed.
Laguna Diagnostics firmographics
Firmographics- Name
- Laguna Diagnostics
- Legal name
- Laguna Diagnostics, LLC
- Website
- https://lagunadiagnostics.com
- Company type
- Private
- Operating status
- Operating
- Short description
- Laguna Diagnostics is a pre-revenue medical diagnostics company developing a blood-based mRNA biomarker test to objectively differentiate schizophrenia from bipolar I disorder for psychiatrists and healthcare systems.
- Ownership category
- akta.pro rank
Laguna Diagnostics industry classification
Industry- Product category
- Psychiatric Molecular Diagnostics
- NAICS
- Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Services-Medical Laboratories (8071)
- akta.pro primary industry
- Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)
- akta.pro secondary industries
- Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI)
Keywords
Where Laguna Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Irvine
- HQ country
- United States
- HQ region
- North America
Markets served
Laguna Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure
Revenue model
- Diagnostic Test Sales: Pre-revenue company. Once FDA clearance is obtained, the company plans to commercialize its mRNA gene biomarker blood test. Revenue model likely to involve sale of diagnostic tests to healthcare providers, hospitals, and psychiatric practices. The company is currently seeking funding for additional development and clinical validation studies.
Go-to-market motion1 record
Laguna Diagnostics product offering
Product offeringCore offering
Laguna Diagnostics develops a blood-based mRNA gene biomarker test designed to aid clinicians in differentiating between schizophrenia and bipolar I disorder. In pivotal studies, the test demonstrated 96.7% sensitivity for schizophrenia, 100% specificity for bipolar I disorder, and 98.3% overall accuracy. The company is pre-commercial and advancing through the FDA Breakthrough Device program with continued clinical validation.
Product overview
Laguna Diagnostics offers a single diagnostic product: the mRNA Gene Biomarker Test. This is a blood-based test that analyzes mRNA gene biomarkers to aid clinicians in differentiating between schizophrenia and bipolar I disorder, addressing the significant diagnostic challenge where current methods show misdiagnosis rates exceeding 50% and timelines of 1-3+ years.
Differentiator
Problem solved
Functional benefit
Products and services
- mRNA Gene Biomarker Test A blood-based diagnostic test that analyzes mRNA gene biomarkers to help clinicians differentiate between schizophrenia and bipolar I disorder in patients presenting with overlapping psychiatric symptoms. Demonstrated 96.7% sensitivity for schizophrenia, 100% specificity for bipolar I disorder, and 98.3% overall accuracy in pivotal studies. Intended for use by psychiatrists, mental health clinicians, healthcare systems, and psychiatric facilities.
Quantifiable outcome
- 96.7% sensitivity for schizophrenia detection
- +2 more outcomes
Companies that use Laguna Diagnostics
Customer profileSegments2 records
Ideal customer profiles2 records
Laguna Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature1 record
Laguna Diagnostics partnerships and signals
Strategic signalScale indicators2 records
Recent moves3 records
Expansion highlights3 records
Laguna Diagnostics competitors and assessment
Company assessmentMarket position
Competitive moat3 records
Key highlights5 records
Customer concentration
Laguna Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Laguna Diagnostics leadership team
Management profileNumber of profiles
Laguna Diagnostics funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Laguna Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Laguna Diagnostics
What does Laguna Diagnostics do?
Laguna Diagnostics develops a blood-based mRNA gene biomarker test designed to aid clinicians in differentiating between schizophrenia and bipolar I disorder. In pivotal studies, the test demonstrated 96.7% sensitivity for schizophrenia, 100% specificity for bipolar I disorder, and 98.3% overall accuracy. The company is pre-commercial and advancing through the FDA Breakthrough Device program with continued clinical validation.
Is Laguna Diagnostics a public or private company?
Laguna Diagnostics is a private company. It is classified as unknown and is currently operating.
When was Laguna Diagnostics founded?
Laguna Diagnostics was founded in -1.
Where is Laguna Diagnostics based?
Laguna Diagnostics is headquartered in Irvine, United States, in the North America region.
How does Laguna Diagnostics make money?
One revenue line is on record: diagnostic Test Sales.
Does Laguna Diagnostics have an API?
No public API is recorded for Laguna Diagnostics.
What industry is Laguna Diagnostics in?
Laguna Diagnostics's product category is Psychiatric Molecular Diagnostics. Its primary akta.pro industry code is HLAGADAF, Molecular & Genetic Testing (PCR/NGS/qPCR), with a secondary code of HLAAAMAC, Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays). Its NAICS code is 621511 and its SIC code is 8071.