ALZpath
ALZpath, founded in 2020 in Carlsbad, California, develops a proprietary monoclonal pTau217 antibody that enables blood-based detection of Alzheimer's disease pathology, licensing it to major IVD companies (Abbott, Roche, Siemens, Beckman Coulter) and offering an LDT through Neurocode for clinicians and researchers.
- Company typePrivate
- Founded2020
- HeadquartersCarlsbad, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What ALZpath does
ALZpath, Inc. is a privately held diagnostics company founded in 2020 in Carlsbad, California, focused on blood-based detection of Alzheimer's disease pathology. Its core asset is a proprietary monoclonal antibody targeting phosphorylated tau 217 (pTau217), an early protein biomarker that the company and independent studies have shown rises in blood up to 15 years before cognitive symptoms appear. The antibody is offered as a Research Use Only (RUO) reagent and is licensed to leading in vitro diagnostic (IVD) companies — Abbott, Roche, Siemens Healthineers, Beckman Coulter, Quanterix, Bio-Techne, and Alamar Biosciences — for integration into their respective immunoassay platforms (Alinity ci-series, Elecsys, Atellica, DxI, Simoa, Ella/Simple Plex, and NULISA). Performance has been independently validated at AUC 0.92–0.97 across cohorts, with reported 98.2% sensitivity and 95% PPV/NPV at relevant cut-offs.
ALZpath's commercial model rests on three pillars: (1) antibody licensing and royalties from IVD partners developing commercial assays, (2) RUO reagent sales to academic and pharmaceutical researchers, and (3) a clinical testing service via the ALZpathDx laboratory developed test (LDT), offered through CAP/CLIA-certified partner Neurocode at $349 per test on a patient-pay basis (no CPT code in place; a PLA code exists). Go-to-market is partnership-driven and evidence-led: the company cites 200+ peer-reviewed publications across 18 countries, 157 conference posters/presentations, and validation studies including a December 2025 Nature paper analyzing 11,000+ samples. It pursues recognition through scientific channels rather than traditional sales, with award validation including TIME Best Inventions 2024, Fast Company Most Innovative Companies 2025, Edison Bronze, and BioTech Breakthrough Diagnostics Innovation of the Year 2025.
The company targets three primary user groups: clinicians and healthcare systems seeking non-invasive, scalable Alzheimer's detection to replace or triage PET imaging and lumbar punctures; pharmaceutical companies and academic researchers using pTau217 in clinical-trial enrollment, endpoint assessment, and biomarker discovery; and patients/caregivers seeking earlier answers. The total addressable market — global blood-based Alzheimer's biomarkers — is projected at $654.4M by 2035 (15.1% CAGR from 2025). Headcount is reported at 11–50 employees, and the company is led by CEO Mike Banville (appointed January 2025), with scientific co-founder Eric Reiman (CEO of Banner Alzheimer's Institute) and co-founder/chair Jerre Stead. Funding to date consists of an undisclosed grant from the Alzheimer's Drug Discovery Foundation's Diagnostics Accelerator (July 2023); no revenue has been disclosed.
ALZpath firmographics
Firmographics- Name
- ALZpath
- Legal name
- ALZpath, Inc.
- Website
- https://alzpath.bio
- Company type
- Private
- Founded year
- 2020
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- ALZpath, founded in 2020 in Carlsbad, California, develops a proprietary monoclonal pTau217 antibody that enables blood-based detection of Alzheimer's disease pathology, licensing it to major IVD companies (Abbott, Roche, Siemens, Beckman Coulter) and offering an LDT through Neurocode for clinicians and researchers.
- Ownership category
- akta.pro rank
ALZpath industry classification
Industry- Product category
- Alzheimer's Disease Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB)
- akta.pro secondary industry
- Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD)
Keywords
Where ALZpath is headquartered
LocationHeadquarters
- HQ city
- Carlsbad
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
ALZpath business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel
Revenue model
- Antibody Licensing: ALZpath licenses its proprietary pTau217 antibody to diagnostic companies for development and commercialization of in vitro diagnostic tests. Licensing agreements with Abbott, Roche, Siemens Healthineers, Beckman Coulter Diagnostics, Bio-Techne, Alamar Biosciences, and Quanterix generate licensing fees and ongoing royalties.
- Laboratory Developed Test (LDT) Services: ALZpathDx test available through Neurocode laboratory as a CLIA-certified laboratory developed test, providing direct revenue from clinical testing services.
- Grant Funding: Received undisclosed funding from Alzheimer's Drug Discovery Foundation's Diagnostics Accelerator for development and clinical validation of blood-based diagnostic assay.
- Research Use Only (RUO) Reagent Sales: The pTau217 antibody is available as Research Use Only reagent for researchers and diagnostic developers through direct partnerships and platform licensing arrangements.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | Pay-as-you-go | ALZpathDx Laboratory Developed Test |
Go-to-market motion3 records
Distribution channels9 records
Marketing channels8 records
ALZpath product offering
Product offeringCore offering
ALZpath develops and commercializes a proprietary monoclonal pTau217 antibody that enables blood-based detection of Alzheimer's disease pathology up to 15 years before symptoms appear. The company licenses this antibody to leading in vitro diagnostic companies (Abbott, Roche, Siemens Healthineers, Beckman Coulter) for integration into their immunoassay platforms, and offers ALZpathDx as a laboratory developed test through Neurocode. The antibody achieves AUC values of 0.92-0.97 for detecting amyloid and tau pathology, matching the performance of PET imaging and cerebrospinal fluid testing.
Product overview
ALZpath offers a focused diagnostic portfolio centered on its proprietary pTau217 monoclonal antibody, which serves as the core technology powering blood-based Alzheimer's disease detection. The company's flagship product is the ALZpath pTau217 Antibody—a research-use and diagnostic-grade reagent that detects phosphorylated tau 217, one of the earliest biomarkers of Alzheimer's pathology, enabling detection up to 15 years before symptoms appear. This antibody is licensed to leading diagnostic companies including Abbott, Roche, Beckman Coulter Diagnostics, Siemens Healthineers, Alamar Biosciences, Bio-Techne, and Quanterix for integration into their respective testing platforms (Alinity ci-series, Elecsys, DxI, Atellica, NULISA, Ella/Simple Plex, and Simoa). For direct clinical access, ALZpath offers ALZpathDx, a laboratory developed test (LDT) available through CLIA-certified partner Neurocode, providing blood-based pTau217 testing for patients with cognitive concerns. The company is pursuing FDA clearance for its assays as In Vitro Diagnostics (IVDs).
Differentiator
Problem solved
Functional benefit
Products and services
- ALZpath pTau217 Antibody A proprietary monoclonal antibody that detects phosphorylated tau 217 (pTau217), a key protein biomarker of Alzheimer's disease pathology. The antibody serves as the scientific foundation for blood-based Alzheimer's diagnostic tests and is licensed to leading diagnostic companies for integration into their immunoassay platforms (Abbott Alinity ci-series, Roche Elecsys, Siemens Atellica, Beckman Coulter DxI, Quanterix Simoa, Bio-Techne Ella, and Alamar NULISA).
- ALZpathDx A blood-based laboratory developed test (LDT) using the ALZpath pTau217 antibody to detect Alzheimer's disease pathology through measurement of pTau217 protein levels in EDTA plasma. Available through Neurocode, a CAP/CLIA certified partner laboratory, for individuals 55 and older experiencing cognitive decline; ordered by a physician at $349 per test. Currently not FDA approved; available as LDT only.
Quantifiable outcome
- AUC 0.92-0.97 for amyloid and tau detection across independent cohorts
- +5 more outcomes
Companies that use ALZpath
Customer profileNamed customers9 records
Segments4 records
Ideal customer profiles3 records
ALZpath technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration7 records
AI capability1 record
Feature5 records
ALZpath partnerships and signals
Strategic signalPartnerships
Eleven partnerships are on record, tiered core and supporting.
- AbbottcoreGlobal licensing agreement to incorporate ALZpath's proprietary pTau217 antibody into Abbott's in vitro diagnostic test for Alzheimer's disease, designed for use on Abbott's Alinity ci-series systems representing one of the largest install bases of immunoassay instruments worldwide.
- Siemens HealthineerscoreLicensing agreement for Siemens Healthineers to utilize ALZpath's pTau217 antibody in development of pTau217 assay for Atellica immunoassay systems, expanding global access to Alzheimer's diagnostic testing.
- Bio-TechnecoreStrategic partnership to advance neurodegenerative disease research utilizing pTau217 antibody on Bio-Techne's Ella/Simple Plex immunoassay platform.
- Beckman Coulter DiagnosticscoreLicensing agreement to provide proprietary pTau217 antibody for development of diagnostic blood test for Alzheimer's disease on Beckman Coulter's DxI series immunoassay platform.
- RochecoreLicensing agreement for use of ALZpath's proprietary pTau217 antibody in blood test to diagnose Alzheimer's disease, utilizing Roche's Elecsys immunoassay platform.
- Alamar BiosciencessupportingStrategic supply agreement for pTau217 antibody to advance Alzheimer's disease research using Alamar's NULISA ultra-sensitive proteomics platform.
- QuanterixcorePlatform partnership for integration of pTau217 antibody into Quanterix's Simoa HD-X (and SR-X) immunoassay platform enabling ultra-sensitive detection of pTau217 in research settings.
- NeurocodecoreCAP/CLIA certified laboratory partnership offering ALZpathDx test, the first LDT using the ALZpath antibody, available across the United States for clinical diagnosis of Alzheimer's disease.
- Eli LillysupportingPartnered with Eli Lilly for Alzheimer's blood test development as part of Fast Company's Most Innovative Companies feature.
- Banner Alzheimer's InstitutesupportingResearch collaboration with Banner Alzheimer's Institute, a leader in Alzheimer's prevention research, as part of extensive academic partnership network including ADNI, University of Gothenburg, and others.
- ADNI (Alzheimer's Disease Neuroimaging Initiative)supportingCollaboration as part of the ADNI consortium contributing to Alzheimer's research biomarker standardization and clinical validation studies.
Scale indicators10 records
Recent moves6 records
Expansion highlights5 records
ALZpath competitors and assessment
Company assessmentDirect peers
- C2N Diagnostics: C2N Diagnostics offers PrecivityAD, a blood-based Alzheimer's diagnostic test measuring amyloid probability via mass spectrometry. It is the most direct competitor to ALZpath's ALZpathDx LDT, addressing the same clinical use case for patients with cognitive concerns.
- Fujirebio: Fujirebio has FDA Breakthrough Device Designation for the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, the most clinically advanced blood-based AD IVD. They compete head-to-head with ALZpath-licensed assays being developed on Roche/Siemens/Beckman platforms.
- Quanterix: Quanterix operates the Simoa HD-X ultra-sensitive immunoassay platform and is both an ALZpath licensing partner and a potential competitor in the research-use biomarker space. Comparable in offering ultra-sensitive blood-based neurology biomarker detection.
- Araclon Biotech (Grifols): Araclon Biotech (subsidiary of Grifols) develops the ABtest for amyloid-beta blood-based detection in Alzheimer's. It is a direct competitor to ALZpath's pTau217-based approach for blood-based AD pathology detection.
Broad incumbents
- Eli Lilly: Eli Lilly has internal pTau217 assay development capabilities (Jeff Dage pioneered p-tau assays at Lilly for 20+ years) and is also a partnered company of ALZpath. As the developer of Kisunla and a major AD therapeutics player, Lilly is both a customer and a potential competitor for AD diagnostics.
- Roche Diagnostics: Roche is an ALZpath licensing partner for the Elecsys platform but also operates the world's largest immunoassay installed base and has internal biomarker development capabilities. As a broad IVD incumbent, Roche is both ALZpath's largest near-term revenue opportunity and its most capable long-term competitor.
Emerging players
- Sysmex: Sysmex has developed the HISCL series of fully automated immunoassay analyzers and is actively pursuing Alzheimer's blood-based diagnostics. They represent an emerging IVD platform competitor pursuing the same clinical market as ALZpath-licensed assays.
- ADx NeuroSciences: ADx NeuroSciences is a biomarker-focused company developing assays and reagents for neurodegenerative disease diagnostics. It operates in the same antibody/biomarker infrastructure layer as ALZpath and supplies major IVD players including Fujirebio.
- MagQu Co., Ltd. MagQu develops immunomagnetic reduction (IMR) technology for ultra-sensitive blood-based detection of biomarkers including those for Alzheimer's disease (e.g., Aβ42, tau). Comparable as an emerging diagnostic technology platform targeting the same AD blood-test market.
Others
- Bio-Techne: Bio-Techne is both an ALZpath licensing partner (Ella/Simple Plex platform) and a major supplier of research-use-only antibodies and immunoassay reagents. It functions as a complementary ecosystem participant rather than a direct diagnostic competitor.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat6 records
Key risks7 records
Key highlights7 records
Customer concentration
ALZpath social profiles
Digital presenceALZpath compliance and trust
Trust signalCompliance1 record
ALZpath financial estimates
Financial estimateRevenue estimate
Valuation estimate
ALZpath leadership team
Management profileNumber of profiles
Profiles18 records
ALZpath funding detail
Funding detailFunding overview
Funding rounds3 records
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
ALZpath 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 ALZpath
What does ALZpath do?
ALZpath develops and commercializes a proprietary monoclonal pTau217 antibody that enables blood-based detection of Alzheimer's disease pathology up to 15 years before symptoms appear. The company licenses this antibody to leading in vitro diagnostic companies (Abbott, Roche, Siemens Healthineers, Beckman Coulter) for integration into their immunoassay platforms, and offers ALZpathDx as a laboratory developed test through Neurocode. The antibody achieves AUC values of 0.92-0.97 for detecting amyloid and tau pathology, matching the performance of PET imaging and cerebrospinal fluid testing.
Is ALZpath a public or private company?
ALZpath is a private company. It is classified as unknown and is currently operating.
When was ALZpath founded?
ALZpath was founded in 2020. It employs 11 to 50 people.
Where is ALZpath based?
ALZpath is headquartered in Carlsbad, United States, in the North America region.
How does ALZpath make money?
Four revenue lines are on record. Antibody Licensing is the primary driver. The others are laboratory Developed Test (LDT) Services, grant Funding and research Use Only (RUO) Reagent Sales.
Who are ALZpath's main competitors?
Direct peers on record are C2N Diagnostics, Fujirebio, Quanterix and Araclon Biotech (Grifols). Broad incumbents are Eli Lilly and Roche Diagnostics. Emerging players are Sysmex, ADx NeuroSciences and MagQu Co., Ltd.. Bio-Techne is listed as an others.
Does ALZpath have an API?
No public API is recorded for ALZpath.
What industry is ALZpath in?
ALZpath's product category is Alzheimer's Disease Diagnostics. Its primary akta.pro industry code is HLAAAIAB, Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering), with a secondary code of HLAHAAAD, Molecular Diagnostics (PCR/NAAT/NGS-based IVD). Its NAICS code is 325413 and its SIC code is 2835.