SPEAR UltraDetect

JSON twin: https://www.healthaidb.com/software/spear-ultradetect.json

Company Name

Spear Bio

Product URL

https://spear.bio/products/

Company URL

https://spear.bio

Categories

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

Summary

SPEAR UltraDetect™ is an ultrasensitive immunoassay platform developed by Spear Bio, designed for precise detection of low-abundance biomarkers in neurological research, enabling early diagnosis and monitoring of neurodegenerative diseases.

Description

SPEAR UltraDetect™ utilizes Spear Bio's proprietary Successive Proximity Extension Amplification Reaction (SPEAR) technology to deliver highly sensitive, specific, and precise biomarker measurements without the need for wash steps. The platform offers assays targeting key neurological biomarkers, including phosphorylated tau 231 (pTau231), phosphorylated tau 217 (pTau217), glial fibrillary acidic protein (GFAP), and neurofilament light (NfL), facilitating research in Alzheimer's disease, traumatic brain injury, multiple sclerosis, and amyotrophic lateral sclerosis. The assays are compatible with standard qPCR systems, ensuring robust integration into existing laboratory workflows. In July 2025, Spear Bio partnered with Bio-Techne to distribute SPEAR UltraDetect™ immunoassays globally, expanding access to these advanced diagnostic tools. Additionally, in January 2025, the U.S. Food and Drug Administration granted Breakthrough Device Designation to Spear Bio's pTau 217 blood test, highlighting its potential in early Alzheimer's disease diagnosis. Founded in 2021 and headquartered in Woburn, Massachusetts, Spear Bio is dedicated to revolutionizing biomarker research and diagnostics through innovation and accessibility.

Api Available

unknown

Certifications

• FDA 510(k)
• CE/MDR
• ONC
• ISO 13485
• ISO 9001

Company Founding

2021

Company Offices

• United States
• Canada
• United Kingdom
• Germany
• France
• Japan
• China
• India
• Australia
• Brazil

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001

Customers

Data Residency

US/EU regions

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Homogeneous immunoassay platform
• Ultra-sensitive detection without wash steps
• Attomolar concentration quantification
• High specificity with two-factor authentication mechanism
• Compatible with various qPCR systems
• Scalable and robust biomarker measurement
• Precise quantification of low-abundance biomarkers
• Integration into existing laboratory workflows

Id

SW2596

Integration Partners

Integrations

• Bio-Techne distribution network
• Various qPCR systems
• Laboratory information management systems (LIMS)

Languages Supported

• English
• Spanish
• French
• German
• Chinese
• Japanese
• Korean
• Portuguese
• Italian
• Russian

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb
• consumer

Optional Modules

• Advanced data analytics
• Automated reporting
• Cloud-based data storage
• Real-time monitoring
• Customizable assay panels
• Integration with laboratory information management systems (LIMS)
• Multi-user collaboration tools
• Data visualization dashboards
• Regulatory compliance tracking
• Audit trail management

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• Business Associate Agreement (BAA) available
• Consent management
• Data anonymization
• Data minimization

Product Code

SW2596

Product Name

SPEAR UltraDetect

Ratings

Regions Available

• United States
• Canada
• Europe
• Asia
• Australia
• South America
• Africa

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
• Neurodegenerative Diseases
• Alzheimer's Disease
• Traumatic Brain Injury
• Multiple Sclerosis
• Amyotrophic Lateral Sclerosis

Support Channels

System Requirements

Compatible qPCR systems, Laboratory information management systems (LIMS)

Target Users

• clinicians
• researchers
• laboratory technicians
• biotech companies
• pharmaceutical companies

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "company_name": "Spear Bio",
  "product_url": "https://spear.bio/products/",
  "company_url": "https://spear.bio",
  "related_urls": [],
  "product_code": "SW2596",
  "summary": "SPEAR UltraDetect™ is an ultrasensitive immunoassay platform developed by Spear Bio, designed for precise detection of low-abundance biomarkers in neurological research, enabling early diagnosis and monitoring of neurodegenerative diseases.",
  "description": "SPEAR UltraDetect™ utilizes Spear Bio's proprietary Successive Proximity Extension Amplification Reaction (SPEAR) technology to deliver highly sensitive, specific, and precise biomarker measurements without the need for wash steps. The platform offers assays targeting key neurological biomarkers, including phosphorylated tau 231 (pTau231), phosphorylated tau 217 (pTau217), glial fibrillary acidic protein (GFAP), and neurofilament light (NfL), facilitating research in Alzheimer's disease, traumatic brain injury, multiple sclerosis, and amyotrophic lateral sclerosis. The assays are compatible with standard qPCR systems, ensuring robust integration into existing laboratory workflows. In July 2025, Spear Bio partnered with Bio-Techne to distribute SPEAR UltraDetect™ immunoassays globally, expanding access to these advanced diagnostic tools. Additionally, in January 2025, the U.S. Food and Drug Administration granted Breakthrough Device Designation to Spear Bio's pTau 217 blood test, highlighting its potential in early Alzheimer's disease diagnosis. Founded in 2021 and headquartered in Woburn, Massachusetts, Spear Bio is dedicated to revolutionizing biomarker research and diagnostics through innovation and accessibility.",
  "categories": [
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    "Biomarker Detection"
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  "market_segment": [
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  "target_users": [
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    "researchers",
    "laboratory technicians",
    "biotech companies",
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  ],
  "specialties": [
    "Neurology",
    "Neurodegenerative Diseases",
    "Alzheimer's Disease",
    "Traumatic Brain Injury",
    "Multiple Sclerosis",
    "Amyotrophic Lateral Sclerosis"
  ],
  "regions_available": [
    "United States",
    "Canada",
    "Europe",
    "Asia",
    "Australia",
    "South America",
    "Africa"
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  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Chinese",
    "Japanese",
    "Korean",
    "Portuguese",
    "Italian",
    "Russian"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Canada",
    "United Kingdom",
    "Germany",
    "France",
    "Japan",
    "China",
    "India",
    "Australia",
    "Brazil"
  ],
  "company_founding": "2021",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
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  "features": [
    "Homogeneous immunoassay platform",
    "Ultra-sensitive detection without wash steps",
    "Attomolar concentration quantification",
    "High specificity with two-factor authentication mechanism",
    "Compatible with various qPCR systems",
    "Scalable and robust biomarker measurement",
    "Precise quantification of low-abundance biomarkers",
    "Integration into existing laboratory workflows"
  ],
  "optional_modules": [
    "Advanced data analytics",
    "Automated reporting",
    "Cloud-based data storage",
    "Real-time monitoring",
    "Customizable assay panels",
    "Integration with laboratory information management systems (LIMS)",
    "Multi-user collaboration tools",
    "Data visualization dashboards",
    "Regulatory compliance tracking",
    "Audit trail management"
  ],
  "integrations": [
    "Bio-Techne distribution network",
    "Various qPCR systems",
    "Laboratory information management systems (LIMS)"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "unknown",
  "system_requirements": "Compatible qPCR systems, Laboratory information management systems (LIMS)",
  "compliance": [
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    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO 13485",
    "ISO 9001"
  ],
  "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) available",
    "Consent management",
    "Data anonymization",
    "Data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW2596",
  "slug": "spear-ultradetect",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/spear-ultradetect.json"
  }
}