Elecsys pTau181

JSON twin: https://www.healthaidb.com/software/elecsys-ptau181.json

Company Name

Roche

Product URL

https://diagnostics.roche.com/global/en/products/lab/elecsys-phospho-tau-181p-plasma-pid00001042.html

Company URL

https://www.roche.com

Categories

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

Summary

Elecsys pTau181 is a minimally invasive blood test developed by Roche to help rule out Alzheimer's disease by measuring phosphorylated tau (pTau) 181 protein levels, thereby reducing the need for more invasive confirmatory tests.

Description

Elecsys pTau181 is an in vitro diagnostic blood test that quantifies phosphorylated tau (pTau) 181 protein levels, a biomarker associated with Alzheimer's disease. It is designed to assist clinicians in ruling out Alzheimer's pathology in patients presenting with cognitive decline, potentially reducing the need for more invasive procedures like positron emission tomography (PET) scans or cerebrospinal fluid (CSF) assessments. The test has received CE Mark certification in Europe and is available on Roche's cobas® e 402 and e 801 analytical units, with a testing time of 18 minutes and a sample volume of 30 μL. Clinical studies have demonstrated a high negative predictive value of 93.8%, supporting its use in primary care settings for early assessment of cognitive concerns.

Api Available

no

Certifications

• CE Mark
• FDA 510(k)
• FDA Breakthrough Device Designation

Company Founding

1896

Company Offices

• Switzerland
• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Netherlands
• Belgium
• Austria

Compliance

• IVDR
• FDA 510(k)
• FDA Breakthrough Device Designation

Customers

Data Residency

EU-only, US/EU regions

Data Standards

• IVDR
• FDA 510(k)
• FDA Breakthrough Device Designation

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• In vitro diagnostic test for Alzheimer's disease
• Measures phosphorylated Tau (pTau181) protein levels
• Available on cobas® e 402 and e 801 analyzers
• Testing time: 18 minutes
• Sample volume: 30 μL plasma
• Two-step sandwich assay principle
• Onboard reagent stability: 16 weeks
• CE Mark certified
• FDA 510(k) cleared for CSF assays
• FDA Breakthrough Device Designation for pTau217 plasma test

Id

SW2594

Integration Partners

Integrations

• cobas® e 402 analyzer
• cobas® e 801 analyzer
• cobas® e 411 analyzer
• cobas® e 601/602 modules

Languages Supported

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

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• cobas® e 411 analyzer
• cobas® e 601/602 modules

Os Platforms

• Web
• Windows
• macOS
• Linux

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• Data anonymization
• Consent management
• Data minimization

Product Code

SW2594

Product Name

Elecsys pTau181

Ratings

Regions Available

• Europe
• United States
• Australia
• Canada
• 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

• Data encryption
• Access control
• Audit trails

Specialties

• Neurology
• Geriatrics
• Cognitive Disorders

Support Channels

System Requirements

cobas® e 402 analyzer, cobas® e 801 analyzer, cobas® e 411 analyzer, cobas® e 601/602 modules

Target Users

• clinicians
• neurologists
• primary care physicians
• patients

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "Elecsys pTau181",
  "company_name": "Roche",
  "product_url": "https://diagnostics.roche.com/global/en/products/lab/elecsys-phospho-tau-181p-plasma-pid00001042.html",
  "company_url": "https://www.roche.com",
  "related_urls": [],
  "product_code": "SW2594",
  "summary": "Elecsys pTau181 is a minimally invasive blood test developed by Roche to help rule out Alzheimer's disease by measuring phosphorylated tau (pTau) 181 protein levels, thereby reducing the need for more invasive confirmatory tests.",
  "description": "Elecsys pTau181 is an in vitro diagnostic blood test that quantifies phosphorylated tau (pTau) 181 protein levels, a biomarker associated with Alzheimer's disease. It is designed to assist clinicians in ruling out Alzheimer's pathology in patients presenting with cognitive decline, potentially reducing the need for more invasive procedures like positron emission tomography (PET) scans or cerebrospinal fluid (CSF) assessments. The test has received CE Mark certification in Europe and is available on Roche's cobas® e 402 and e 801 analytical units, with a testing time of 18 minutes and a sample volume of 30 μL. Clinical studies have demonstrated a high negative predictive value of 93.8%, supporting its use in primary care settings for early assessment of cognitive concerns.",
  "categories": [
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    "Biomarker Testing"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
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    "neurologists",
    "primary care physicians",
    "patients"
  ],
  "specialties": [
    "Neurology",
    "Geriatrics",
    "Cognitive Disorders"
  ],
  "regions_available": [
    "Europe",
    "United States",
    "Australia",
    "Canada",
    "Japan",
    "South Korea",
    "China",
    "India",
    "Brazil",
    "Mexico",
    "Argentina",
    "Chile",
    "Colombia",
    "Peru",
    "South Africa",
    "Egypt",
    "Saudi Arabia",
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    "Israel",
    "Turkey"
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  "languages_supported": [
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    "German",
    "French",
    "Spanish",
    "Italian",
    "Portuguese",
    "Dutch",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Turkish",
    "Hebrew",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Tamil",
    "Telugu",
    "Marathi"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "Switzerland",
    "United States",
    "Germany",
    "France",
    "United Kingdom",
    "Italy",
    "Spain",
    "Netherlands",
    "Belgium",
    "Austria"
  ],
  "company_founding": "1896",
  "deployment_model": [
    "SaaS",
    "on_prem",
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  "os_platforms": [
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    "Windows",
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  ],
  "features": [
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    "Measures phosphorylated Tau (pTau181) protein levels",
    "Available on cobas® e 402 and e 801 analyzers",
    "Testing time: 18 minutes",
    "Sample volume: 30 μL plasma",
    "Two-step sandwich assay principle",
    "Onboard reagent stability: 16 weeks",
    "CE Mark certified",
    "FDA 510(k) cleared for CSF assays",
    "FDA Breakthrough Device Designation for pTau217 plasma test"
  ],
  "optional_modules": [
    "cobas® e 411 analyzer",
    "cobas® e 601/602 modules"
  ],
  "integrations": [
    "cobas® e 402 analyzer",
    "cobas® e 801 analyzer",
    "cobas® e 411 analyzer",
    "cobas® e 601/602 modules"
  ],
  "data_standards": [
    "IVDR",
    "FDA 510(k)",
    "FDA Breakthrough Device Designation"
  ],
  "api_available": "no",
  "system_requirements": "cobas® e 402 analyzer, cobas® e 801 analyzer, cobas® e 411 analyzer, cobas® e 601/602 modules",
  "compliance": [
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    "FDA 510(k)",
    "FDA Breakthrough Device Designation"
  ],
  "certifications": [
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    "FDA 510(k)",
    "FDA Breakthrough Device Designation"
  ],
  "security_features": [
    "Data encryption",
    "Access control",
    "Audit trails"
  ],
  "privacy_features": [
    "Data anonymization",
    "Consent management",
    "Data minimization"
  ],
  "data_residency": "EU-only, US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW2594",
  "slug": "elecsys-ptau181",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/elecsys-ptau181.json"
  }
}