Moleculera Biosciences, Inc.

What Moleculera Biosciences, Inc. does

Moleculera Biosciences, Inc. is a CAP-accredited, CLIA-certified clinical diagnostic laboratory headquartered in Oklahoma City that develops and commercializes blood-based autoantibody testing panels aimed at identifying immune-mediated causes of neuropsychiatric, cardiovascular, and neurodegenerative disorders. The company's technology platform combines high-complexity immunoassays (the flagship Autoimmune Brain Panel comprises five blood tests evaluating antineuronal antibodies), a curated longitudinal biorepository of phenotypically characterized patient specimens linked to treatment and outcome data, and a biomarker and targeted therapeutic identification program. The core Autoimmune Brain Panel is positioned as the only commercially available test of its kind for evaluating whether a patient's neuropsychiatric symptoms — including anxiety, OCD, tics, depression, ADHD, chronic fatigue, autism spectrum disorder, Lyme disease, epilepsy, and PANS/PANDAS — stem from an underlying autoimmune response triggered by infection.

The company sells its panels through a sales-led, primarily B2B model targeting the more than 2,500 clinicians worldwide who order testing for treatment-resistant cases, with a secondary direct-to-patient self-referral pathway. Revenue is generated per panel order through laboratory testing fees paid by healthcare providers and patients, with insurance reimbursement supported through dedicated cost-and-insurance pages; international ordering is also available. Distribution is increasingly routed through a 2024 strategic collaboration with Quest Diagnostics, and AI-enabled predictive treatment capability is being layered on through a strategic alliance with General Genomics (supported by a 2024 OCAST grant). Beyond the commercialized Brain Panel, Moleculera is developing an Autoimmune Cardiovascular Panel and, through a 2026 alliance with Lunai Bioworks, an Alzheimer's Early Intervention Inflammatory Biomarker (AEIIB) Panel. The company was founded in 2011 by Madeleine Cunningham (Chief Scientific Officer) and Craig Shimasaki (Chief Executive Officer) and operates with 11–50 employees.

Name

Moleculera Biosciences, Inc.

Legal name

Moleculera Biosciences, Inc.

Website

https://moleculeralabs.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

Moleculera Biosciences is a CAP-accredited clinical diagnostic laboratory offering blood-based autoantibody testing panels for immune-mediated neuropsychiatric, cardiovascular, and neurodegenerative disorders, serving 2,500+ clinicians and self-referring patients worldwide from its Oklahoma City facility.

Ownership category

akta.pro rank

Product category

Clinical Diagnostics

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215), Medical and Diagnostic Laboratories (62151)

SIC

Services-Medical Laboratories (8071)

akta.pro primary industry

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

akta.pro secondary industries

Clinical Chemistry & Immunoassay Laboratories (HLAFAMAB), Proteomics & Biomarker Analytical Testing (HLAGADAG), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

Keywords

• Autoimmune diagnostics
• Clinical laboratory testing
• Precision medicine
• Neuropsychiatric testing
• Blood-based biomarkers

Headquarters

HQ city

Oklahoma City

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales

Revenue model

1. Clinical Diagnostic Testing Services: The company operates a clinical diagnostic testing laboratory providing autoantibody testing panels. Revenue is generated through laboratory testing fees charged to healthcare providers and patients, with insurance reimbursement as a key payment mechanism.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels6 records

Core offering

Moleculera Biosciences operates a specialty clinical laboratory that provides blood-based autoantibody testing panels designed to identify immune-mediated contributions to neuropsychiatric, cardiovascular, and neurodegenerative disorders. Its flagship offering is the Autoimmune Brain Panel™, complemented by the Autoimmune Cardiovascular Panel™ and the AEIIB Panel™ in development. Testing services are ordered by licensed clinicians and, where permitted, directly by patients.

Product overview

Moleculera Biosciences is a precision medicine company offering a portfolio of blood-based autoantibody testing panels for immune-mediated disorders. The flagship product is the Autoimmune Brain Panel™, a commercially available test analyzing five high-complexity blood tests to detect autoimmune dysfunction causing neuropsychiatric symptoms. The company is also developing the Autoimmune Cardiovascular Panel™ and the Alzheimer's Early Intervention Inflammatory Biomarker (AEIIB) Panel™ as pipeline products. The technology platform comprises three integrated components: blood-based autoantibody testing panels, a curated biorepository of phenotypically specimens, and a biomarker and targeted therapeutic identification program. Strategic alliances with General Genomics (AI-powered personalized medicine) and Lunai Bioworks (Alzheimer's biomarker panel) support product development.

Differentiator

Problem solved

Functional benefit

Brands

• Autoimmune Brain Panel™: High-complexity blood tests that assist clinicians in determining whether neuropsychiatric symptoms may be due to autoimmune dysfunction.
• Autoimmune Cardiovascular Panel™
• Alzheimer's Early Intervention Inflammatory Biomarker (AEIIB) Panel™

Products and services

• Autoimmune Brain Panel™ Proprietary blood-based autoantibody panel that evaluates a patient's immune response against neuronal targets to help clinicians identify autoimmune contributions to neuropsychiatric symptoms. Used by psychiatrists, neurologists, and pediatricians managing treatment-resistant cases.
• Autoimmune Cardiovascular Panel™ Blood-based autoantibody testing panel intended to identify immune-mediated contributors to cardiovascular disease. Targeted at cardiologists and internal medicine providers seeking diagnostic clarity in complex cases.
• AEIIB Panel™ Pipeline blood-based autoantibody panel under development to detect immune-mediated components associated with Alzheimer's disease and related neurodegenerative conditions.

Quantifiable outcome

• 20-60% of patients with neuropsychiatric disorders do not respond to standard treatments, potentially due to undiagnosed immune-mediated causes
• +1 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Three partnerships are on record, tiered core and minor.

• Quest DiagnosticscoreChannel Partner/ Reseller/ DistributorStrategic collaboration to broaden access to Moleculera's novel neuropsychiatric autoantibody testing through Quest Diagnostics' extensive laboratory network and customer base.
• General GenomicscoreStrategic or Co-development PartnerStrategic alliance to utilize proprietary AI to provide personalized medicine for autoimmune neuropsychiatric disorders. Collaboration includes $500,000 grant funding to develop predictive treatment algorithm for immune-mediated neuropsychiatric disorders.
• Lunai BioworksminorStrategic or Co-development PartnerAlliance to advance first-of-its-kind biomarker panel for Alzheimer's disease, advancing the company's pipeline into Alzheimer's early intervention inflammatory biomarker testing.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• MNG Laboratories (LabCorp): MNG Laboratories, now part of LabCorp, specializes in neuroimmunology and autoimmune neurological disorder testing, including encephalitis and paraneoplastic panels. It is the most directly comparable peer, offering similar blood-based autoimmune neurological diagnostic panels to neurologists and psychiatrists.
• Athena Diagnostics (Quest Diagnostics): Athena Diagnostics, a Quest subsidiary, provides specialized genetic and molecular testing for neurological and psychiatric conditions. It overlaps with Moleculera's autoimmune neuropsychiatric focus through its specialized neuro-diagnostic menu targeting similar clinician customers.
• Exagen Inc. Exagen develops and commercializes autoimmune disease diagnostic tests, most prominently for lupus and related connective tissue diseases. It is directly comparable as a specialty autoimmune diagnostics company selling proprietary testing panels to rheumatologists and other specialty clinicians.
• Genova Diagnostics: Genova Diagnostics is a specialty clinical laboratory offering innovative testing across immunology, neurology, and metabolic disorders. It is comparable to Moleculera as a specialty lab that combines proprietary assays with provider-direct ordering for complex chronic conditions.

Broad incumbents

• ARUP Laboratories: ARUP is a major nonprofit clinical reference laboratory offering an extensive menu that includes autoimmune encephalitis and paraneoplastic antibody panels. It is a broad incumbent with overlapping capabilities in specialty autoimmune testing delivered to academic medical centers and hospitals.
• Mayo Clinic Laboratories: Mayo Clinic Laboratories is a major reference laboratory offering extensive specialty testing, including autoimmune neurology and encephalitis antibody evaluations. Comparable as a large incumbent with strong clinical credibility offering overlapping high-complexity neuro-immunology assays.
• Laboratory Corporation of America (LabCorp): LabCorp is one of the largest clinical laboratory networks in the U.S., providing a broad menu including autoimmune and neurological specialty testing. It serves as a broad incumbent competitor whose scale and payer relationships could enable rapid entry into autoimmune neuropsychiatric panels.
• Quest Diagnostics: Quest Diagnostics is a national clinical laboratory leader that has now entered into a strategic collaboration with Moleculera. Beyond being a channel partner, Quest operates a broad specialty testing menu and could potentially internalize comparable autoimmune neuro panels, making it both an enabler and a potential competitive threat.
• EUROIMMUN (PerkinElmer): EUROIMMUN, now part of Revvity/PerkinElmer, is a global leader in autoimmune diagnostics with an extensive antibody testing menu used by clinical laboratories. Comparable as a specialty autoimmune diagnostics provider whose products could be deployed by reference labs to replicate Moleculera's panel.

Regional players

• Cleveland Clinic Laboratories: Cleveland Clinic Laboratories provides reference testing including autoimmune neurology panels, primarily serving health systems and academic clients. It is a regional specialty lab with overlapping autoimmune neuro testing capabilities but a narrower geographic and customer reach than Moleculera's expanding channel.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/moleculeralabs
• Facebookfacebook.com/moleculeralabs

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds5 records

Investors5 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Moleculera Biosciences, Inc.