Elecsys pTau217

JSON twin: https://www.healthaidb.com/software/elecsys-ptau217.json

Company Name

Roche

Product URL

https://www.roche.com/products/elecsys-ptau217

Company URL

https://www.roche.com

Categories

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

Summary

Elecsys pTau217 is a blood-based diagnostic test developed by Roche to detect amyloid pathology associated with Alzheimer's disease, aiding in early and accurate diagnosis.

Description

Elecsys pTau217 is an in-vitro diagnostic immunoassay designed to quantitatively measure the phosphorylated tau (pTau217) protein in human plasma. Developed in collaboration with Eli Lilly and Company, the test aims to identify amyloid pathology, a hallmark of Alzheimer's disease, in individuals aged 60 and older. A positive result indicates a high likelihood of amyloid positivity, while a negative result suggests a high likelihood of amyloid negativity. The test is intended to be used alongside other clinical information in the diagnostic pathway. In April 2024, the U.S. Food and Drug Administration granted Breakthrough Device Designation to the Elecsys pTau217 assay, recognizing its potential to improve early and accurate Alzheimer's diagnosis. Additionally, in June 2024, Roche entered into a licensing agreement with ALZpath, Inc. to incorporate ALZpath's proprietary pTau217 antibody into the Elecsys pTau217 test, enhancing its diagnostic capabilities. As of October 2024, the test is under development and not yet commercially available. If approved, it is expected to be marketed and supported in various regions, including the United States and Europe, with potential availability in other countries as well.

Api Available

unknown

Certifications

• FDA Breakthrough Device Designation
• CE Mark
• ISO/IEC 27001
• ISO 27017
• ISO 27018
• ISO 13485

Company Founding

1896

Company Offices

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

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001
• ISO 27017
• ISO 27018
• ISO 13485

Customers

Data Residency

US/EU regions

Data Standards

• FDA Breakthrough Device Designation
• CE Mark
• ISO/IEC 27001
• ISO 27017
• ISO 27018
• ISO 13485

Deployment Model

• on_prem
• SaaS

Features

• In-vitro diagnostic immunoassay
• Quantitative determination of Phospho-Tau (217P) in human plasma
• Aid in identifying amyloid pathology associated with Alzheimer's disease
• High throughput and full automation
• Stable at room and refrigerator temperatures
• Compatible with Roche's installed base of diagnostic systems

Id

SW2595

Integration Partners

Integrations

• Roche diagnostic systems
• Laboratory Information Systems (LIS)
• Middleware
• Point-of-care instruments

Languages Supported

• English
• German
• French
• Spanish
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Turkish
• Hebrew
• Hindi
• Bengali
• Punjabi
• Telugu
• Marathi
• Tamil

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• Remote support services
• Software distribution
• Cybersecurity measures
• Data privacy management
• Connectivity solutions

Os Platforms

• Windows
• Linux
• macOS

Pricing Details

Pricing details are not publicly available; please contact Roche for more information.

Pricing Model

contact vendor

Privacy Features

• Business Associate Agreement (BAA)
• Consent management
• Anonymization
• Data minimization

Product Code

SW2595

Product Name

Elecsys pTau217

Ratings

Regions Available

• United States
• Europe
• Canada
• Australia
• Japan
• South Korea
• China
• India
• Brazil
• Mexico
• Argentina
• Chile
• Colombia
• Peru
• South Africa
• Egypt
• Saudi Arabia
• United Arab Emirates
• Israel
• Turkey

Related Urls

Release Year

Security Features

• Encryption
• Role-Based Access Control (RBAC)
• Single Sign-On (SSO)
• Audit logs
• Two-Factor Authentication (2FA)
• Data Loss Prevention (DLP)

Specialties

• Neurology
• Geriatrics

Support Channels

System Requirements

• Roche diagnostic systems
• Laboratory Information Systems (LIS)
• Middleware
• Point-of-care instruments

Target Users

• clinicians
• patients
• researchers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "company_name": "Roche",
  "product_url": "https://www.roche.com/products/elecsys-ptau217",
  "company_url": "https://www.roche.com",
  "related_urls": [],
  "product_code": "SW2595",
  "summary": "Elecsys pTau217 is a blood-based diagnostic test developed by Roche to detect amyloid pathology associated with Alzheimer's disease, aiding in early and accurate diagnosis.",
  "description": "Elecsys pTau217 is an in-vitro diagnostic immunoassay designed to quantitatively measure the phosphorylated tau (pTau217) protein in human plasma. Developed in collaboration with Eli Lilly and Company, the test aims to identify amyloid pathology, a hallmark of Alzheimer's disease, in individuals aged 60 and older. A positive result indicates a high likelihood of amyloid positivity, while a negative result suggests a high likelihood of amyloid negativity. The test is intended to be used alongside other clinical information in the diagnostic pathway. In April 2024, the U.S. Food and Drug Administration granted Breakthrough Device Designation to the Elecsys pTau217 assay, recognizing its potential to improve early and accurate Alzheimer's diagnosis. Additionally, in June 2024, Roche entered into a licensing agreement with ALZpath, Inc. to incorporate ALZpath's proprietary pTau217 antibody into the Elecsys pTau217 test, enhancing its diagnostic capabilities. As of October 2024, the test is under development and not yet commercially available. If approved, it is expected to be marketed and supported in various regions, including the United States and Europe, with potential availability in other countries as well.",
  "categories": [
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  "specialties": [
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  "regions_available": [
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  "languages_supported": [
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  "pricing_model": "contact vendor",
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  "license": "commercial",
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    "United States",
    "Germany",
    "France",
    "United Kingdom",
    "Italy",
    "Spain",
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    "Japan"
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  "deployment_model": [
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  "features": [
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    "High throughput and full automation",
    "Stable at room and refrigerator temperatures",
    "Compatible with Roche's installed base of diagnostic systems"
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  "optional_modules": [
    "Remote support services",
    "Software distribution",
    "Cybersecurity measures",
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  "data_standards": [
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    "ISO/IEC 27001",
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    "ISO 13485"
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  "api_available": "unknown",
  "system_requirements": [
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    "ISO 27001",
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    "ISO 27018",
    "ISO 13485"
  ],
  "certifications": [
    "FDA Breakthrough Device Designation",
    "CE Mark",
    "ISO/IEC 27001",
    "ISO 27017",
    "ISO 27018",
    "ISO 13485"
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  "security_features": [
    "Encryption",
    "Role-Based Access Control (RBAC)",
    "Single Sign-On (SSO)",
    "Audit logs",
    "Two-Factor Authentication (2FA)",
    "Data Loss Prevention (DLP)"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA)",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW2595",
  "slug": "elecsys-ptau217",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
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