Access p-Tau217/β-Amyloid 1-42 plasma ratio test

JSON twin: https://www.healthaidb.com/software/access-p-tau217-amyloid-1-42-plasma-ratio-test.json

Company Name

Beckman Coulter

Product URL

https://www.beckmancoulter.com/products/immunoassay/neurology/plasma-p-tau217-assay

Company URL

https://www.beckmancoulter.com

Categories

• diagnostic Support
• clinical Care
• neurology
• laboratory Testing
• Diagnostic
• Clinical
• Biomarker Analysis

Summary

Beckman Coulter's Access p-Tau217/β-Amyloid 1-42 plasma ratio test is a blood-based assay designed to aid in the early detection of Alzheimer's disease by measuring key biomarkers associated with amyloid pathology.

Description

The Access p-Tau217/β-Amyloid 1-42 plasma ratio test is a blood-based in vitro diagnostic (IVD) assay developed by Beckman Coulter Diagnostics. It quantifies the ratio of phosphorylated tau protein (p-Tau217) to β-Amyloid 1-42, two biomarkers implicated in Alzheimer's disease. This assay provides a non-invasive, accessible method for early detection of Alzheimer's-related pathology, facilitating timely intervention and patient stratification for therapeutic trials. The test has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), underscoring its potential to transform Alzheimer's disease diagnosis and management. The assay is available for use on Beckman Coulter's DxI 9000 Immunoassay Analyzer and Access 2 Analyzer, supporting high-throughput clinical research applications. Additionally, Beckman Coulter is developing an Aβ-42 Research Use Only (RUO) immunoassay test to complement the p-Tau217 assay, further advancing neurodegenerative disease diagnostics. The company is committed to providing innovative, high-quality assays that deliver accurate and affordable testing solutions at scale, aiming to make neurodegenerative disease diagnostics more accessible worldwide.

Api Available

no

Certifications

• FDA Breakthrough Device Designation

Company Founding

1935

Company Offices

• United States
• United Kingdom
• Germany
• France
• Italy
• Spain
• Netherlands
• China
• Japan
• India

Compliance

• FDA Breakthrough Device Designation
• Research Use Only (RUO) assay

Customers

Data Residency

US/EU regions

Data Standards

• FDA Breakthrough Device Designation
• Research Use Only (RUO) assay
• DxI 9000 Immunoassay Analyzer compatibility
• Lumi-Phos PRO substrate utilization
• Neurodegenerative disease research support
• Alzheimer's disease detection
• Plasma p-Tau217 measurement
• Plasma β-Amyloid 1-42 measurement
• p-Tau217/β-Amyloid 1-42 ratio calculation
• Non-invasive blood-based testing

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Automated immunoassay testing
• High-throughput analysis
• Plasma p-Tau217 measurement
• Plasma β-Amyloid 1-42 measurement
• p-Tau217/β-Amyloid 1-42 ratio calculation
• FDA Breakthrough Device Designation for Alzheimer's disease detection
• Research Use Only (RUO) assay
• Compatible with DxI 9000 Immunoassay Analyzer
• Utilizes Lumi-Phos PRO substrate for enhanced sensitivity
• Supports neurodegenerative disease research
• Enables early detection of Alzheimer's-related pathology
• Non-invasive blood-based testing
• High sensitivity and precision in biomarker detection
• Supports clinical-grade platforms for neurodegenerative diseases
• Facilitates patient stratification for therapeutic trials
• Accelerates Alzheimer's research and treatment
• Integrates with advanced immunoassay platforms
• Provides clinically relevant assay development
• Supports evolving healthcare needs in diagnostics
• Enhances diagnostic accuracy for Alzheimer's disease

Id

SW2571

Integration Partners

• DxI 9000 Immunoassay Analyzer
• Access 2 Analyzer

Integrations

• DxI 9000 Immunoassay Analyzer

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Bengali
• Punjabi
• Gujarati
• Tamil
• Telugu
• Marathi
• Malayalam
• Kannada

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb
• consumer

Optional Modules

• DxI 9000 Immunoassay Analyzer
• DxI 9000 Immunoassay Analyzer with Lumi-Phos PRO substrate
• DxI 9000 Immunoassay Analyzer for high-throughput analysis
• DxI 9000 Immunoassay Analyzer for neurodegenerative disease research
• DxI 9000 Immunoassay Analyzer for Alzheimer's disease detection
• DxI 9000 Immunoassay Analyzer for plasma p-Tau217 measurement
• DxI 9000 Immunoassay Analyzer for plasma β-Amyloid 1-42 measurement
• DxI 9000 Immunoassay Analyzer for p-Tau217/β-Amyloid 1-42 ratio calculation
• DxI 9000 Immunoassay Analyzer for non-invasive blood-based testing
• DxI 9000 Immunoassay Analyzer for high sensitivity and precision in biomarker detection

Os Platforms

• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• Data anonymization
• Data minimization
• Informed consent management
• Data access controls
• Data retention policies
• Compliance with privacy regulations
• Regular privacy audits
• User training on privacy best practices
• Data sharing agreements
• Privacy impact assessments

Product Code

SW2571

Product Name

Access p-Tau217/β-Amyloid 1-42 plasma ratio test

Ratings

Regions Available

• United States
• Europe
• Asia
• Australia
• Canada
• South America
• Africa
• Middle East
• India
• China
• Japan
• South Korea
• Southeast Asia
• Russia
• Mexico
• Brazil
• Argentina
• Chile
• Colombia
• Peru
• Venezuela

Related Urls

Release Year

2025

Security Features

• Data encryption
• Access control
• Audit trails
• User authentication
• Data integrity checks
• Compliance with regulatory standards
• Secure data storage
• Regular security updates
• Incident response protocols
• User training on security best practices

Specialties

• Neurology
• Geriatrics
• Clinical Research

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

DxI 9000 Immunoassay Analyzer

Target Users

• clinicians
• researchers
• patients
• admins

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "company_name": "Beckman Coulter",
  "product_url": "https://www.beckmancoulter.com/products/immunoassay/neurology/plasma-p-tau217-assay",
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  "product_code": "SW2571",
  "summary": "Beckman Coulter's Access p-Tau217/β-Amyloid 1-42 plasma ratio test is a blood-based assay designed to aid in the early detection of Alzheimer's disease by measuring key biomarkers associated with amyloid pathology.",
  "description": "The Access p-Tau217/β-Amyloid 1-42 plasma ratio test is a blood-based in vitro diagnostic (IVD) assay developed by Beckman Coulter Diagnostics. It quantifies the ratio of phosphorylated tau protein (p-Tau217) to β-Amyloid 1-42, two biomarkers implicated in Alzheimer's disease. This assay provides a non-invasive, accessible method for early detection of Alzheimer's-related pathology, facilitating timely intervention and patient stratification for therapeutic trials. The test has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), underscoring its potential to transform Alzheimer's disease diagnosis and management. The assay is available for use on Beckman Coulter's DxI 9000 Immunoassay Analyzer and Access 2 Analyzer, supporting high-throughput clinical research applications. Additionally, Beckman Coulter is developing an Aβ-42 Research Use Only (RUO) immunoassay test to complement the p-Tau217 assay, further advancing neurodegenerative disease diagnostics. The company is committed to providing innovative, high-quality assays that deliver accurate and affordable testing solutions at scale, aiming to make neurodegenerative disease diagnostics more accessible worldwide.",
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    "Supports neurodegenerative disease research",
    "Enables early detection of Alzheimer's-related pathology",
    "Non-invasive blood-based testing",
    "High sensitivity and precision in biomarker detection",
    "Supports clinical-grade platforms for neurodegenerative diseases",
    "Facilitates patient stratification for therapeutic trials",
    "Accelerates Alzheimer's research and treatment",
    "Integrates with advanced immunoassay platforms",
    "Provides clinically relevant assay development",
    "Supports evolving healthcare needs in diagnostics",
    "Enhances diagnostic accuracy for Alzheimer's disease"
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    "DxI 9000 Immunoassay Analyzer for neurodegenerative disease research",
    "DxI 9000 Immunoassay Analyzer for Alzheimer's disease detection",
    "DxI 9000 Immunoassay Analyzer for plasma p-Tau217 measurement",
    "DxI 9000 Immunoassay Analyzer for plasma β-Amyloid 1-42 measurement",
    "DxI 9000 Immunoassay Analyzer for p-Tau217/β-Amyloid 1-42 ratio calculation",
    "DxI 9000 Immunoassay Analyzer for non-invasive blood-based testing",
    "DxI 9000 Immunoassay Analyzer for high sensitivity and precision in biomarker detection"
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    "Regular security updates",
    "Incident response protocols",
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    "Data sharing agreements",
    "Privacy impact assessments"
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  "customers": [],
  "user_reviews": [],
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  "release_year": "2025",
  "integration_partners": [
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  "id": "SW2571",
  "slug": "access-p-tau217-amyloid-1-42-plasma-ratio-test",
  "type": "product",
  "version": "1.0",
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