What Amprion does

Amprion, Inc. is a privately held diagnostics company founded in 2014 and headquartered in San Diego, California, that develops and commercializes seed amplification assay (SAA) technology for detecting misfolded proteins associated with neurodegenerative diseases. The company's flagship product, the SAAmplify-αSYN test (formerly SYNTap), is the first clinically available and validated cerebrospinal fluid (CSF) assay for detecting pathological α-synuclein with autopsy-confirmed accuracy, reporting 96% sensitivity and 92% specificity for alpha-synuclein pathology and over 98% correlation with diffuse Lewy body disease in autopsy cohorts. The test is performed at Amprion's CAP-accredited and CLIA-certified clinical laboratory (the world's first such facility for SAA testing) and is offered as a Laboratory Developed Test (LDT) commercially available for clinical and research use.

Amprion operates a hybrid business model with two principal revenue streams: (1) clinical laboratory testing services billed through physician orders (neurologists, geriatricians, and psychiatrists prescribe the test, which requires a lumbar puncture and CSF sample shipped to the San Diego lab), with reimbursement pursued across Medicare, Medicaid, and private insurers; and (2) biopharma partnership services including patient stratification, endpoint selection, target engagement studies, preclinical/assay development, and project management for drug developers. The platform is supported by an extensive intellectual property portfolio spanning the US, Europe, Asia, and other jurisdictions, covering detection methodology, substrates, and differential diagnosis applications (e.g., discriminating Parkinson's from multiple system atrophy).

The company is founder-led by CEO Dr. Russell Lebovitz and CSO Dr. Claudio Soto (the inventor of the underlying SAA technology, awarded the 2024 Robert A. Pritzker Prize). Amprion serves three primary customer segments: patients and care partners seeking biological diagnostic clarity, clinicians ordering the test for diagnostic and treatment-decision support, and biopharma enterprises using the assay for clinical trial biomarker services. Strategic distribution is anchored in physician ordering via Amprion's website, complemented by annual participation in major neurodegenerative disease conferences (AAN, AD/PD, AAIC, MDS, ANPA, CTAD) and embedded research partnerships with MJFF, ADDF, Parkinson's Foundation, ADNI, and NIA. The company also markets itself through its NeuroSAAvvy blog and peer-reviewed scientific publications.

Name

Amprion

Legal name

Amprion, Inc.

Website

https://ampriondx.com

Company type

Private

Founded year

2014

Operating status

Operating

Short description

Amprion is a San Diego-based clinical diagnostics company that develops and commercializes the SAAmplify-αSYN seed amplification assay, the first clinically validated test for detecting misfolded α-synuclein in cerebrospinal fluid to diagnose Parkinson's, Lewy body dementia, and related neurodegenerative diseases, serving clinicians, patients, and biopharma partners.

Ownership category

akta.pro rank

Product category

Clinical Diagnostic Laboratory Services (Neurodegenerative Disease Diagnostics)

NAICS

Medical and Diagnostic Laboratories (6215), Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835), Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

Laboratory Developed Tests (LDTs) & Specialized Clinical Lab Assays (HLAAALAN)

akta.pro secondary industries

Proteomics & Biomarker Analytical Testing (HLAGADAG), Biomarker Discovery & Validation (omics, assay feasibility, clinical validation) (HLAAAMAA), Bioanalytical & PK/PD Sample Analysis (Trial Support) (HLAGAEAG), Translational & Pharmacodynamic Biomarkers (MOA, target engagement, PD/PK-linked markers) (HLAAAMAD)

Keywords

• Seed amplification assays
• Neurodegenerative diagnostics
• Alpha-synuclein testing
• Biomarker laboratory services
• Clinical diagnostic testing

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Laboratory Testing Services: Amprion generates revenue through providing clinical diagnostic testing services via its CAP/CLIA-certified laboratory. The SAAmplify-αSYN test is offered as a Laboratory Developed Test (LDT) commercially available for clinical use. Revenue comes from test fees billed to insurance (Medicare, Medicaid, private insurers) or self-pay patients.
2. Biopharma Partnership Services: Amprion provides biomarker detection services to pharmaceutical companies for clinical trial support, including patient stratification, endpoint selection, and monitoring in drug development programs. Services include project management, sample logistics, data management, and assay services.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

Amprion commercializes the SAAmplify-αSYN test, a cerebrospinal fluid (CSF)-based Seed Amplification Assay that detects misfolded α-synuclein proteins with 96% sensitivity and 92% specificity, providing autopsy-confirmed biological confirmation of synucleinopathies including Parkinson's disease, Dementia with Lewy bodies, Multiple System Atrophy, and Alzheimer's with Lewy body co-pathology. The company also offers Research Use Only (RUO) qualitative and semi-quantitative SAA assay variants for biopharma drug development, and a suite of R&D laboratory services encompassing target engagement studies, preclinical proof-of-concept studies, custom assay development, and biopharma project management and data services.

Product overview

Amprion offers a diagnostic testing platform centered on its proprietary Seed Amplification Assay (SAA) technology. The core product is the SAAmplify-αSYN test (formerly SYNTap), the first and only commercially available clinically validated test that detects misfolded α-synuclein in cerebrospinal fluid with autopsy-confirmed accuracy. The platform also includes Research Use Only (RUO) assays for biopharma drug development, semi-quantitative variants for enhanced research sensitivity, and comprehensive R&D laboratory services including target engagement studies, preclinical studies, and custom assay development. Services extend to biopharma partners through project management, sample logistics coordination, results reporting, and data management solutions. The company operates the world's first and only CAP/CLIA-certified laboratory offering SAA technology as a Laboratory Developed Test (LDT) for clinical and research use.

Differentiator

Problem solved

Functional benefit

Brands

• SAAmplify-αSYN: Seed amplification assay test for detecting misfolded α-synuclein proteins in cerebrospinal fluid, used for diagnosis of Parkinson's disease, Lewy body dementia, and Alzheimer's with Lewy body co-pathology. Formerly known as SYNTap.
• NeuroSAAvvy

Products and services

• SAAmplify-αSYN Test A cerebrospinal fluid (CSF)-based Seed Amplification Assay (SAA) sold as a Laboratory Developed Test (LDT) that detects misfolded α-synuclein proteins with 96% sensitivity and 92% specificity, providing autopsy-confirmed accuracy for diagnosing Parkinson's disease, Dementia with Lewy bodies, Multiple System Atrophy, and Alzheimer's with Lewy body co-pathology. Ordered by physicians via lumbar puncture; samples are shipped to Amprion's CAP/CLIA-certified San Diego laboratory for analysis.
• SAAmplify-αSYN RUO Qualitative synSAA Research Use Only qualitative seed amplification assay enhanced for multiple system atrophy (MSA) detection, sold to biopharma and academic research programs as part of Amprion's expanded laboratory services.
• SAAmplify-αSYN RUO Semi-Quantitative synSAA for PD/DLB Research Use Only semi-quantitative seed amplification assay for Parkinson's disease and Dementia with Lewy bodies, sold to research programs to enable more granular measurement of seeding activity for research applications.
• SAAmplify-αSYN RUO Semi-Quantitative synSAA for MSA Research Use Only semi-quantitative seed amplification assay optimized for multiple system atrophy (MSA), sold to research programs to support differential diagnosis research between PD/DLB and MSA synucleinopathies.
• R&D Laboratory Services Research and development services sold to biopharma partners, including target engagement studies, mechanism of action analysis, drug interference screening in SAA, kinetic parameter analysis, proof-of-concept and preclinical studies (animal models, iPSC cellular models, serial dilution studies, seeding activity impact), and custom assay development (peripheral matrices such as blood and skin, tissue extraction protocol optimization, seed enrichment, and additional misfolded protein assays).
• Biopharma Project Management & Data Services Comprehensive enterprise services for biopharma clients including project acquisition, implementation management, timeline analysis, contracting, clinical lab audits, data transfer agreements, and data upload services to designated CRO or data vendors.

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Seven partnerships are on record, tiered core, flagship and minor.

• Modality.AIcoreTechnology or Integration · 9 July 2026Partnership for multimodal assessment in neurodegenerative disease combining Amprion's SAAmplify-αSYN biomarker testing with Modality.AI's AI-powered assessment technologies for more comprehensive patient evaluation.
• Michael J. Fox Foundation for Parkinson's ResearchflagshipStrategic or Co-development Partner · 3 July 2026$5 million partnership between ADDF's Diagnostics Accelerator (DxA) and MJFF to accelerate development of minimally invasive biomarkers for measuring pathologies in Parkinson's and Alzheimer's diseases. Focuses on detecting alpha-synuclein co-pathology. Builds on prior investments including the cerebrospinal fluid assay by University of Texas scientists that led to Amprion's spinout. Amprion partnered with MJFF's Parkinson's Precision Medicine Initiative (PPMI).
• Australian Research PartnersminorStrategic or Co-development Partner · 1 April 2026Amprion expanded global footprint through Australian partnership and expanded research collaborations supporting international biomarker research initiatives.
• Michael J. Fox FoundationflagshipStrategic or Co-development PartnerIn 2023, MJFF announced a breakthrough facilitated by Amprion's SAAmplify-αSYN test, stating it 'heralds the revolutionary ability for research to define Parkinson's disease biologically, offering a critical tool for clinical trial design and assessment of treatment effects, and for early detection of disease pathology.'
• Alzheimer's Disease Neuroimaging Initiative (ADNI)coreStrategic or Co-development PartnerResearch partnership contributing data and samples to ADNI, a major public-private partnership focused on Alzheimer's disease research biomarker validation.
• Parkinson's FoundationcoreStrategic or Co-development PartnerResearch collaboration with the Parkinson's Foundation to advance understanding of neurodegenerative disease biomarkers and improve patient outcomes.
• National Institute on Aging (NIA)coreStrategic or Co-development PartnerResearch partnership supported by NIA, part of NIH, for advancing neurodegenerative disease research and biomarker development.

Scale indicators6 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Quanterix: Quanterix provides ultra-sensitive single-molecule array biomarker detection platforms used in neurodegenerative disease research and pharma biomarker services, making it a direct peer in the high-sensitivity biomarker measurement and biopharma services space.
• C2N Diagnostics: C2N Diagnostics commercializes the PrecivityAD blood-based biomarker test for Alzheimer's pathology, making it a direct peer to Amprion in biological confirmation of neurodegenerative disease biology using proprietary assay platforms sold to clinicians and biopharma.
• ADx NeuroSciences: ADx NeuroSciences develops immunoassays for Alzheimer's, Parkinson's, and other neurodegenerative biomarkers, including alpha-synuclein assays. It is a direct peer given overlapping target proteins, assay technologies, and biopharma/biomarker services business model.

Broad incumbents

• Roche Diagnostics: Roche operates the world's largest in-vitro diagnostics business with Elecsys CSF assays for Alzheimer's and an active neurodegenerative disease pipeline. It is a broad incumbent competing with Amprion across clinical diagnostic menus and pharma trial biomarker services.
• Biogen: Biogen has strategic interests in neurodegenerative diagnostics tied to its Alzheimer's therapeutic portfolio (aducanumab, lecanemab) and has historically invested in biomarker collaborations. It is a broad incumbent with overlapping CNS biomarker strategy and partnerships.
• Fujirebio: Fujirebio is a leading Japanese diagnostics company with an established CSF biomarker portfolio (amyloid-beta, tau) and global pharma services, making it a broad incumbent in neurodegenerative disease testing adjacent to Amprion's CSF SAA platform.
• Euroimmun (Revvity / PerkinElmer): Euroimmun, now part of Revvity, provides a broad menu of neurodegenerative autoantibody and biomarker assays including alpha-synuclein and tau ELISAs. It is a broad incumbent offering overlapping CNS diagnostic capabilities with global commercial reach.
• Eli Lilly: Eli Lilly has invested heavily in tau diagnostic development (via Avid Radiopharmaceuticals) and amyloid biomarkers to support its Alzheimer's therapeutics franchise. It competes with Amprion as a deep-pocketed incumbent integrating biomarkers with disease-modifying therapy.

Emerging players

• Araclon Biotech: Araclon Biotech develops blood-based biomarker tests (ABtest) for Alzheimer's disease amyloid pathology and is an emerging player in neurodegenerative diagnostics. It is comparable to Amprion in focus on biological confirmation of CNS proteinopathies, though concentrated on amyloid rather than alpha-synuclein.
• Prothena Biosciences: Prothena develops alpha-synuclein-targeted therapies and biomarker programs for synucleinopathies and is both a potential customer (biopharma services) and adjacent player in defining biological diagnostic standards for Parkinson's — relevant as a peer given shared focus on alpha-synuclein biology.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/amprion-inc
• Xx.com/AmprionDx

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 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 Amprion