Laboratory Testing Services

JSON twin: https://www.healthaidb.com/software/laboratory-testing-services.json

Company Name

US Specialty Labs

Product URL

https://usspecialtylabs.com

Company URL

https://usspecialtylabs.com

Categories

• clinical Care
• diagnostic Support
• patient Facing
• laboratory Testing
• telehealth
• patient Screening
• clinical Research
• medical Device
• regulatory Compliance
• point-of-care
• Clinical
• Diagnostic
• Telemedicine
• Health Screening
• Research
• Ivd Manufacturing
• Fda-cleared Assays
• Point-of-care Testing

Summary

US Specialty Labs offers high-complexity laboratory testing services, specializing in processing patient-collected samples mailed to their lab, including non-traditional samples like capillary finger-stick, saliva, and menstrual blood.

Description

Founded in 2011, US Specialty Labs is a CLIA and CAP accredited, NGSP Certified high-complexity laboratory based in San Diego, California. They specialize in processing patient-collected samples mailed to their lab, including non-traditional samples like capillary finger-stick, saliva, and menstrual blood. Their services support various clients, including direct-to-consumer brands, telemedicine providers, pharmacies, health screening organizations, research arms of universities, and IVD manufacturers. They are licensed in all 50 states and have supplemental licenses in Rhode Island, Maryland, Washington D.C., and Pennsylvania, with additional licensing in New York to run FDA-cleared assays. Their mission is to improve patient care and extend the reach of point-of-care testing initiatives by providing at-home alternatives to testing typically requiring venipuncture, especially in rural markets where access to draw sites is limited.

Api Available

unknown

Certifications

• FDA 510(k)
• CE/MDR
• ONC
• ISO
• CLIA
• CAP
• NGSP
• FDA-cleared assays
• ISO 27001
• SOC 2

Company Founding

2011

Company Offices

• United States

Compliance

• HIPAA
• GDPR
• SOC 2
• ISO 27001
• FDA 510(k)
• CE/MDR
• ONC
• ISO

Customers

• Healthyr
• Ro
• SoWell
• Hone Health
• Imaware
• Spot Health

Data Residency

US-only

Data Standards

• FDA-cleared assays
• CLIA
• CAP
• NGSP
• FDA 510(k)
• ISO 27001
• HIPAA
• GDPR
• SOC 2

Deployment Model

• SaaS

Features

• Processing of patient-collected samples mailed into the lab
• At-home and assisted collection methods
• Non-traditional sample processing (e.g., capillary finger-stick, saliva, menstrual blood)
• CLIA and CAP accreditation
• NGSP certification
• FDA-cleared assays in NY
• Supplemental licenses in RI, MD, DC, PA
• Licensed in all 50 states
• Serving direct-to-consumer brands, clinics, telemedicine providers, pharmacies, health screening organizations, research arms of universities, and IVD manufacturers

Id

SW2441

Integration Partners

• Healthyr
• Ro
• SoWell
• Hone Health
• Imaware
• Spot Health

Integrations

• Healthyr
• Modern Fertility
• Hone Therapeutics
• SoWell
• Base
• Imaware
• Spot Health

Languages Supported

• English

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB
• Consumer

Optional Modules

• Custom laboratory services
• Lab startup consulting
• Laboratory design and buildout
• Compliance audits
• Lab staffing solutions
• CLIA compliance consulting
• CAP accreditation support
• Customized lab workflow solutions
• Toxicology lab services
• Molecular diagnostics services
• Infectious disease labs
• Pathology laboratory setup

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

Contact Vendor

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW2441

Product Name

Laboratory Testing Services

Ratings

• Healthyr chose US Specialty Labs as our partner due to their proven track record serving consumers and their commitment to clinical excellence.

Regions Available

• United States
• Rhode Island
• Maryland
• Washington D.C.
• Pennsylvania
• New York

Related Urls

• https://elion.health/products/us-specialty-labs

Release Year

2011

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP

Specialties

• Fertility Hormone Testing
• Metabolic Health Testing
• Hormone Optimization
• Sti Testing
• Hrt Testing
• Trt Testing
• Saliva Testing
• Menstrual Blood Testing
• Capillary Finger-stick Testing
• Wellness Testing
• Sports Performance Testing
• Glp-1 Testing
• Weight Loss Testing
• Hedis Testing
• Gap Closure Testing
• Chemistry Tests
• Blood Testing
• Urine Testing
• Microsamples
• Dried Blood Cards

Support Channels

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

System Requirements

Target Users

• Clinicians
• Patients
• Telemedicine Providers
• Pharmacies
• Health Screening Organizations
• Researchers
• IVD Manufacturers

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• Healthyr chose US Specialty Labs as our partner due to their proven track record serving consumers and their commitment to clinical excellence.

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Laboratory Testing Services",
  "company_name": "US Specialty Labs",
  "product_url": "https://usspecialtylabs.com",
  "company_url": "https://usspecialtylabs.com",
  "related_urls": [
    "https://elion.health/products/us-specialty-labs"
  ],
  "product_code": "SW2441",
  "summary": "US Specialty Labs offers high-complexity laboratory testing services, specializing in processing patient-collected samples mailed to their lab, including non-traditional samples like capillary finger-stick, saliva, and menstrual blood.",
  "description": "Founded in 2011, US Specialty Labs is a CLIA and CAP accredited, NGSP Certified high-complexity laboratory based in San Diego, California. They specialize in processing patient-collected samples mailed to their lab, including non-traditional samples like capillary finger-stick, saliva, and menstrual blood. Their services support various clients, including direct-to-consumer brands, telemedicine providers, pharmacies, health screening organizations, research arms of universities, and IVD manufacturers. They are licensed in all 50 states and have supplemental licenses in Rhode Island, Maryland, Washington D.C., and Pennsylvania, with additional licensing in New York to run FDA-cleared assays. Their mission is to improve patient care and extend the reach of point-of-care testing initiatives by providing at-home alternatives to testing typically requiring venipuncture, especially in rural markets where access to draw sites is limited.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "laboratory Testing",
    "telehealth",
    "patient Screening",
    "clinical Research",
    "medical Device",
    "regulatory Compliance",
    "point-of-care",
    "Clinical",
    "Diagnostic",
    "Patient-facing",
    "Laboratory Testing",
    "Telemedicine",
    "Health Screening",
    "Research",
    "Ivd Manufacturing",
    "Fda-cleared Assays",
    "Point-of-care Testing"
  ],
  "market_segment": [
    "Enterprise",
    "SMB",
    "Consumer"
  ],
  "target_users": [
    "Clinicians",
    "Patients",
    "Telemedicine Providers",
    "Pharmacies",
    "Health Screening Organizations",
    "Researchers",
    "IVD Manufacturers"
  ],
  "specialties": [
    "Fertility Hormone Testing",
    "Metabolic Health Testing",
    "Hormone Optimization",
    "Sti Testing",
    "Hrt Testing",
    "Trt Testing",
    "Saliva Testing",
    "Menstrual Blood Testing",
    "Capillary Finger-stick Testing",
    "Wellness Testing",
    "Sports Performance Testing",
    "Glp-1 Testing",
    "Weight Loss Testing",
    "Hedis Testing",
    "Gap Closure Testing",
    "Chemistry Tests",
    "Blood Testing",
    "Urine Testing",
    "Microsamples",
    "Dried Blood Cards"
  ],
  "regions_available": [
    "United States",
    "Rhode Island",
    "Maryland",
    "Washington D.C.",
    "Pennsylvania",
    "New York"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "Contact Vendor",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2011",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Processing of patient-collected samples mailed into the lab",
    "At-home and assisted collection methods",
    "Non-traditional sample processing (e.g., capillary finger-stick, saliva, menstrual blood)",
    "CLIA and CAP accreditation",
    "NGSP certification",
    "FDA-cleared assays in NY",
    "Supplemental licenses in RI, MD, DC, PA",
    "Licensed in all 50 states",
    "Serving direct-to-consumer brands, clinics, telemedicine providers, pharmacies, health screening organizations, research arms of universities, and IVD manufacturers"
  ],
  "optional_modules": [
    "Custom laboratory services",
    "Lab startup consulting",
    "Laboratory design and buildout",
    "Compliance audits",
    "Lab staffing solutions",
    "CLIA compliance consulting",
    "CAP accreditation support",
    "Customized lab workflow solutions",
    "Toxicology lab services",
    "Molecular diagnostics services",
    "Infectious disease labs",
    "Pathology laboratory setup"
  ],
  "integrations": [
    "Healthyr",
    "Modern Fertility",
    "Hone Therapeutics",
    "SoWell",
    "Base",
    "Imaware",
    "Spot Health"
  ],
  "data_standards": [
    "FDA-cleared assays",
    "CLIA",
    "CAP",
    "NGSP",
    "FDA 510(k)",
    "ISO 27001",
    "HIPAA",
    "GDPR",
    "SOC 2"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "GDPR",
    "SOC 2",
    "ISO 27001",
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO",
    "CLIA",
    "CAP",
    "NGSP",
    "FDA-cleared assays",
    "ISO 27001",
    "SOC 2"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "US-only",
  "customers": [
    "Healthyr",
    "Ro",
    "SoWell",
    "Hone Health",
    "Imaware",
    "Spot Health"
  ],
  "user_reviews": [
    "Healthyr chose US Specialty Labs as our partner due to their proven track record serving consumers and their commitment to clinical excellence."
  ],
  "ratings": [
    "Healthyr chose US Specialty Labs as our partner due to their proven track record serving consumers and their commitment to clinical excellence."
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2011",
  "integration_partners": [
    "Healthyr",
    "Ro",
    "SoWell",
    "Hone Health",
    "Imaware",
    "Spot Health"
  ],
  "id": "SW2441",
  "slug": "laboratory-testing-services",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/laboratory-testing-services.json"
  }
}