Moleculera Labs, Inc

What Moleculera Labs, Inc does

Moleculera Labs, Inc. (operating as Moleculera Biosciences) is an Oklahoma City-based precision medicine company founded in 2002 that develops and commercializes blood-based autoantibody diagnostic tests for immune-mediated disorders. Its core product, the Autoimmune Brain Panel (formerly the Cunningham Panel), is a series of five high-complexity blood tests measuring autoantibodies against Dopamine D1, Dopamine D2, Lysoganglioside GM1, Tubulin, and CaMKII to help clinicians determine whether neuropsychiatric symptoms — including OCD, tics, anxiety, depression, ADHD, seizures, and PANS/PANDAS — may stem from an infection-triggered autoimmune response rather than primary psychiatric illness. The assay is built on over two decades of research led by Dr. Madeleine Cunningham at the University of Oklahoma in collaboration with the National Institute of Mental Health and is reported as the only commercially available test of its kind, with 88% sensitivity and 83% specificity.

The company operates a sales-led, provider-driven commercial model: clinicians order the test through a prescriber portal, with specimens processed at its Oklahoma City laboratory and collected at designated facilities in all 50 US states and internationally. Pricing is set at $995 per test in the contiguous US ($1,070 for Alaska, Hawaii, and Canada), and the company is out-of-network with all insurance carriers, though it files claims on behalf of patients and roughly 50% receive some reimbursement. The firm also operates Provider and Patient portals, runs monthly webinars for clinician onboarding and patient education, and pursues an extensive content-marketing and conference presence. GTM is supplemented by international ordering partners.

Moleculera's product roadmap is broadening beyond neuropsychiatrics. Pipeline assets include the Autoimmune Cardiovascular Panel and the Alzheimer's Early Intervention Inflammatory Biomarker (AEIIB) Panel being advanced through an alliance with Lunai Bioworks, and the company is developing an AI-powered Predictive Treatment Algorithm with General Genomics under a $500,000 grant. A 2024 strategic collaboration with Quest Diagnostics is intended to broaden patient access through Quest's laboratory network, while a curated biorepository of specimens from 16,000+ tested patients across 2,500+ clinicians globally underpins ongoing biomarker discovery. The company is privately held, founder-controlled, and led by President and CEO Craig Shimasaki, PhD, MBA.

Name

Moleculera Labs, Inc

Legal name

Moleculera Biosciences, Inc.

Website

https://moleculera.com

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

11–50 employees

Short description

Moleculera Biosciences is an Oklahoma City-based precision medicine company that sells the Autoimmune Brain Panel, a five-marker blood test helping clinicians identify infection-triggered autoimmune causes of neuropsychiatric symptoms, and is expanding into cardiovascular and Alzheimer's diagnostics via a Quest Diagnostics distribution partnership and additional pipeline assets.

Ownership category

akta.pro rank

Product category

Clinical Laboratory Services

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Autoimmune, Allergy & Specialized Immunology Diagnostics (HLAHAAAK)

akta.pro secondary industries

Autoimmune & Allergy Diagnostics (HLAAALAK), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

Keywords

• Clinical laboratory testing
• Autoimmune brain panel
• Neuropsychiatric diagnostics
• Autoantibody blood tests
• Precision medicine services

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, Infrastructure

Revenue model

1. Laboratory Testing Services: The company generates revenue primarily through laboratory testing services, specifically the Autoimmune Brain Panel. The test is priced at $995 for contiguous US patients, with international pricing at $1070 for Alaska, Hawaii, and Canada. While out-of-network with all insurance carriers, the company files claims on behalf of patients as a courtesy, with approximately 50% of patients receiving some level of insurance reimbursement.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Moleculera Labs operates a specialty clinical reference laboratory that performs the Autoimmune Brain Panel, a series of five high-complexity blood-based diagnostic tests designed to detect autoantibodies associated with immune-mediated neuropsychiatric disorders. The company also develops additional autoimmune panels in its pipeline and provides associated treatment-decision-support and clinical-research services to healthcare providers.

Product overview

Moleculera Labs, Inc is a precision medicine company offering laboratory diagnostic testing services focused on identifying immune-mediated root causes of neuropsychiatric, cardiovascular, and neurological disorders. The core product is the Autoimmune Brain Panel™ (formerly Cunningham Panel™), a five-marker blood test panel that detects autoantibodies associated with infection-triggered autoimmune encephalopathy affecting the basal ganglia. The company also operates Provider and Patient portals for test ordering and results access. The product portfolio includes commercially available tests and a development pipeline comprising the Autoimmune Cardiovascular Panel™ and Alzheimer's Early Intervention Inflammatory Biomarker (AEIIB) Panel™. The company is also developing a predictive treatment algorithm using AI in partnership with General Genomics.

Differentiator

Problem solved

Functional benefit

Brands

• Autoimmune Brain Panel: A high-complexity blood test panel (formerly Cunningham Panel) that assists clinicians in determining whether neuropsychiatric symptoms may be due to an underlying autoimmune response.
• Cunningham Panel
• Autoimmune Cardiovascular Panel
• Alzheimer's Early Intervention Inflammatory Biomarker Panel (AEIIB)

Products and services

• Autoimmune Brain Panel (Cunningham Panel) High-complexity blood-based diagnostic panel of five tests measuring autoantibodies against neuronal antigens associated with immune-mediated neuropsychiatric disorders such as PANS/PANDAS, OCD, Tourette syndrome, ADHD, and other conditions. Ordered by clinicians (psychiatrists, neurologists, pediatricians, immunologists) for patients with suspected autoimmune encephalopathy.
• Autoimmune Cardiovascular Panel Pipeline autoantibody-based blood panel targeted at cardiovascular disease indications, intended to extend the company's autoimmune testing expertise beyond neuropsychiatric conditions.
• AEIIB Panel Pipeline diagnostic panel in research and development, extending the company's autoantibody testing methodology to additional autoimmune disease indications.
• Clinical Laboratory Testing Services Specialty reference laboratory services (CLIA-licensed, CAP-accredited) processing clinician-ordered high-complexity immunology tests, including specimen logistics, accessioning, analytical testing, and clinical reporting.

Quantifiable outcome

• 88% sensitivity and 83% specificity in detecting autoimmune etiology of neuropsychiatric symptoms
• +2 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

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 flagship.

• Quest DiagnosticscoreStrategic or Co-development PartnerStrategic collaboration to broaden access to Moleculera's novel neuropsychiatric autoantibody testing. This partnership expands patient access to the Autoimmune Brain Panel through Quest Diagnostics' extensive laboratory network.
• General GenomicscoreStrategic or Co-development PartnerStrategic alliance to utilize proprietary AI to provide personalized medicine for autoimmune neuropsychiatric disorders. General Genomics also awarded $500,000 in grant funding to develop a predictive treatment algorithm.
• Lunai BioworksflagshipStrategic or Co-development PartnerAlliance to advance first-of-its-kind biomarker panel for Alzheimer's disease (Alzheimer's Early Intervention Inflammatory Biomarker Panel) to address unmet needs in Alzheimer's early intervention.

Scale indicators6 records

Recent moves5 records

Expansion highlights6 records

Direct peers

• Cyrex Laboratories: Specialty clinical laboratory focused on autoimmune and food-sensitivity testing using array-based immunoassay panels. Comparable to Moleculera as a specialty autoimmune diagnostics lab selling clinician-ordered blood-based panels directly to providers.
• Mosaic Diagnostics (formerly Great Plains Laboratory): Specialty clinical laboratory offering a wide menu of complex blood, urine, and immunology tests marketed to integrative and functional medicine clinicians. Comparable to Moleculera in business model, clinician target segment, and self-pay testing orientation.
• Mayo Clinic Laboratories: Reference laboratory operated by Mayo Clinic offering a broad esoteric test menu including autoimmune neurology and encephalopathy-related diagnostics. Comparable to Moleculera in offering high-complexity specialty immunology testing through clinician orders.
• ARUP Laboratories: University-affiliated reference laboratory offering a wide menu of esoteric and specialty diagnostic tests, including autoimmune and neurologic panels. Comparable to Moleculera as a specialty reference lab serving clinicians with complex immunology testing.
• Genova Diagnostics: Specialty clinical laboratory offering functional, autoimmune, and immunology-related diagnostic testing through clinician channels. Comparable to Moleculera as a specialty lab serving integrative and functional medicine providers with complex blood-based panels.

Broad incumbents

• Quest Diagnostics: Largest US reference laboratory offering broad diagnostic testing services including specialty neurology and autoimmune panels. Directly comparable because it is both Moleculera's strategic distribution partner and a potential competitor capable of launching in-network autoimmune neuro tests.
• Sonic Healthcare: Global clinical laboratory and pathology services company operating reference labs across multiple geographies. Comparable to Moleculera as a broad reference lab with specialty testing capabilities and established international distribution.
• Laboratory Corporation of America (LabCorp): Major US clinical laboratory network with deep payer relationships and an extensive specialty diagnostics menu. Comparable to Moleculera as a competing reference lab capable of developing or acquiring autoimmune neuropsychiatric testing capabilities.

Emerging players

• Vibrant America: Specialty clinical laboratory offering advanced immunology, autoimmune, and microbiome testing panels through clinician channels. Comparable to Moleculera as a specialty diagnostics lab using complex blood-based panels for chronic and autoimmune conditions.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/moleculera-biosciences

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

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 Labs, Inc