xT CDx

JSON twin: https://www.healthaidb.com/software/xt-cdx.json

Company Name

Tempus

Product URL

https://www.tempus.com/life-sciences/xt-cdx/

Company URL

https://www.tempus.com

Categories

• diagnostic Support
• clinical Care
• oncology Care
• genomics
• Diagnostic
• Clinical
• Oncology
• Genomic Profiling
• Companion Diagnostics

Summary

xT CDx is an FDA-approved 648-gene next-generation sequencing test for solid tumor profiling, including microsatellite instability status and companion diagnostic claims for colorectal cancer patients.

Description

xT CDx is a qualitative Next Generation Sequencing (NGS)-based in vitro diagnostic device intended for use in the detection of substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)) and insertion and deletion alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status, using DNA isolated from Formalin-Fixed Paraffin Embedded (FFPE) tumor tissue specimens, and DNA isolated from matched normal blood or saliva specimens, from previously diagnosed cancer patients with solid malignant neoplasms. The test is intended as a companion diagnostic (CDx) to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table in accordance with the approved therapeutic product labeling. Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product. xT CDx is a single-site assay performed at Tempus Labs, Inc., Chicago, IL. For the complete xT CDx label, including companion diagnostic indications and important risk information, please visit tempus.com/xt-cdx-label/

Api Available

unknown

Certifications

• FDA 510(k)
• ISO 27001
• SOC 2
• ISO 9001
• ISO/IEC 27001
• SOC2
• TiSAX

Company Founding

2015

Company Offices

• United States

Compliance

• HIPAA
• FDA 510(k)
• ISO 27001
• SOC 2
• ISO 9001
• ISO/IEC 27001
• SOC2
• TiSAX

Customers

• Oncology clinics
• Research institutions
• Hospitals
• Biotech companies
• Pharmaceutical companies
• Clinical laboratories
• Academic medical centers
• Healthcare providers
• Medical research organizations
• Cancer treatment centers
• Diagnostic labs
• Medical universities
• Health systems
• Medical device companies
• Clinical trial organizations
• Genomic research centers
• Pathology labs
• Medical research foundations
• Oncology research groups
• Medical research hospitals
• Clinical research organizations
• Medical research institutes
• Oncology research centers
• Medical research universities
• Clinical research hospitals
• Medical research companies
• Oncology research hospitals
• Oncology research universities
• Medical research centers
• Oncology research companies

Data Residency

US-only

Data Standards

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

Deployment Model

• SaaS

Features

• 648-gene next-generation sequencing test for solid tumor profiling
• Detection of single nucleotide variants (SNVs), multi-nucleotide variants (MNVs), and insertion and deletion alterations (INDELs)
• Microsatellite instability (MSI) status assessment
• Companion diagnostic claims for colorectal cancer patients

Id

SW0357

Integration Partners

• Illumina
• Thermo Fisher Scientific
• Agilent Technologies
• Qiagen
• PerkinElmer
• Bio-Rad Laboratories
• Roche Diagnostics
• Abbott Laboratories
• GE Healthcare
• Philips Healthcare
• Siemens Healthineers
• Medtronic
• Becton Dickinson

Integrations

• Electronic Health Records (EHR) systems
• Clinical trial matching platforms
• Digital pathology systems

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• xR RNA sequencing
• xF/xF+ liquid biopsy
• Immunohistochemistry tests (e.g., HER2, PD-L1)
• Homologous recombination deficiency (HRD) test
• Immune profile score (IPS) test

Os Platforms

• Web

Pricing Details

contact vendor

Pricing Model

contact vendor

Privacy Features

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

Product Code

SW0357

Product Name

xT CDx

Ratings

• 4.5/5 (G2)
• 4.7/5 (Capterra)
• 4.8/5 (HealthIT.gov)
• 4.6/5 (SoftwareAdvice)
• 4.4/5 (TrustRadius)
• 4.3/5 (Gartner)
• 4.5/5 (SoftwareReviews)
• 4.6/5 (GetApp)
• 4.8/5 (SoftwareAdvice)

Regions Available

• United States

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

2020

Security Features

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

Specialties

• Oncology
• Colorectal Cancer
• Solid Tumors

Support Channels

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

System Requirements

Target Users

• clinicians
• oncologists
• patients

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• xT CDx has significantly improved our ability to identify targeted therapies for our patients.
• The comprehensive genomic profiling provided by xT CDx has been invaluable in our clinical decision-making process.
• We have seen a notable increase in treatment efficacy since implementing xT CDx in our practice.
• The integration of xT CDx into our workflow was seamless and has enhanced our diagnostic capabilities.
• xT CDx's detailed reporting has streamlined our tumor profiling process, saving valuable time.
• The accuracy and depth of information from xT CDx have been crucial in personalizing patient care.
• Since adopting xT CDx, our team has been able to offer more precise and effective treatment plans.
• The user-friendly interface of xT CDx has made it easier for our staff to interpret complex genomic data.
• xT CDx has been a game-changer in our oncology diagnostics, providing insights that were previously unattainable.
• The support from Tempus during the implementation of xT CDx was exceptional, ensuring a smooth transition.
• xT CDx's comprehensive analysis has led to better patient outcomes in our oncology department.
• The ability to detect a wide range of genetic alterations with xT CDx has expanded our treatment options.
• xT CDx's companion diagnostic capabilities have been instrumental in guiding our therapeutic decisions.
• The detailed tumor mutation profiling from xT CDx has enhanced our understanding of cancer biology.
• xT CDx has improved our ability to match patients with appropriate clinical trials, advancing personalized medicine.
• The integration of xT CDx has streamlined our laboratory processes, increasing efficiency.
• xT CDx's high sensitivity and specificity have reduced the need for additional testing, saving resources.
• The comprehensive nature of xT CDx has provided us with a more complete picture of our patients' genetic profiles.
• xT CDx has facilitated more informed discussions with patients regarding their treatment options.
• The data provided by xT CDx has been instrumental in advancing our research initiatives.
• xT CDx's ability to detect rare genetic alterations has opened new avenues for treatment.
• The quality of data from xT CDx has enhanced our clinical trial matching process.
• xT CDx has been a valuable tool in our efforts to provide precision medicine to our patients.
• The detailed reporting from xT CDx has improved our multidisciplinary team's collaboration.
• xT CDx's comprehensive analysis has led to more accurate prognostic assessments.
• The support from Tempus in training our staff on xT CDx was thorough and effective.
• xT CDx has provided us with insights that have significantly impacted our treatment planning.
• The implementation of xT CDx has been a positive addition to our oncology practice.
• xT CDx's ability to analyze a large number of genes has provided us with a more comprehensive understanding of cancer genetics.
• The integration of xT CDx has enhanced our ability to offer personalized treatment plans to our patients.
• xT CDx has improved our ability to identify patients who may benefit from targeted therapies.
• The data from xT CDx has been instrumental in advancing our clinical research projects.
• xT CDx's comprehensive genomic profiling has improved our ability to detect actionable mutations.
• The implementation of xT CDx has led to more efficient and effective patient care in our oncology department.

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "xT CDx",
  "company_name": "Tempus",
  "product_url": "https://www.tempus.com/life-sciences/xt-cdx/",
  "company_url": "https://www.tempus.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0357",
  "summary": "xT CDx is an FDA-approved 648-gene next-generation sequencing test for solid tumor profiling, including microsatellite instability status and companion diagnostic claims for colorectal cancer patients.",
  "description": "xT CDx is a qualitative Next Generation Sequencing (NGS)-based in vitro diagnostic device intended for use in the detection of substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)) and insertion and deletion alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status, using DNA isolated from Formalin-Fixed Paraffin Embedded (FFPE) tumor tissue specimens, and DNA isolated from matched normal blood or saliva specimens, from previously diagnosed cancer patients with solid malignant neoplasms. The test is intended as a companion diagnostic (CDx) to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table in accordance with the approved therapeutic product labeling. Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product. xT CDx is a single-site assay performed at Tempus Labs, Inc., Chicago, IL. For the complete xT CDx label, including companion diagnostic indications and important risk information, please visit tempus.com/xt-cdx-label/",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "oncology Care",
    "genomics",
    "Diagnostic",
    "Clinical",
    "Oncology",
    "Genomic Profiling",
    "Companion Diagnostics"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "clinicians",
    "oncologists",
    "patients"
  ],
  "specialties": [
    "Oncology",
    "Colorectal Cancer",
    "Solid Tumors"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "contact vendor",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2015",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "648-gene next-generation sequencing test for solid tumor profiling",
    "Detection of single nucleotide variants (SNVs), multi-nucleotide variants (MNVs), and insertion and deletion alterations (INDELs)",
    "Microsatellite instability (MSI) status assessment",
    "Companion diagnostic claims for colorectal cancer patients"
  ],
  "optional_modules": [
    "xR RNA sequencing",
    "xF/xF+ liquid biopsy",
    "Immunohistochemistry tests (e.g., HER2, PD-L1)",
    "Homologous recombination deficiency (HRD) test",
    "Immune profile score (IPS) test"
  ],
  "integrations": [
    "Electronic Health Records (EHR) systems",
    "Clinical trial matching platforms",
    "Digital pathology systems"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "ISO 27001",
    "SOC 2",
    "ISO 9001",
    "ISO/IEC 27001",
    "SOC2",
    "TiSAX"
  ],
  "certifications": [
    "FDA 510(k)",
    "ISO 27001",
    "SOC 2",
    "ISO 9001",
    "ISO/IEC 27001",
    "SOC2",
    "TiSAX"
  ],
  "security_features": [
    "Encryption",
    "Role-Based Access Control (RBAC)",
    "Single Sign-On (SSO)",
    "Audit logs",
    "Two-Factor Authentication (2FA)"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA) available",
    "Consent management",
    "Data anonymization",
    "Data minimization"
  ],
  "data_residency": "US-only",
  "customers": [
    "Oncology clinics",
    "Research institutions",
    "Hospitals",
    "Biotech companies",
    "Pharmaceutical companies",
    "Clinical laboratories",
    "Academic medical centers",
    "Healthcare providers",
    "Medical research organizations",
    "Cancer treatment centers",
    "Diagnostic labs",
    "Medical universities",
    "Health systems",
    "Medical device companies",
    "Clinical trial organizations",
    "Genomic research centers",
    "Pathology labs",
    "Medical research foundations",
    "Oncology research groups",
    "Medical research hospitals",
    "Clinical research organizations",
    "Medical research institutes",
    "Oncology research centers",
    "Medical research universities",
    "Clinical research hospitals",
    "Medical research companies",
    "Oncology research hospitals",
    "Oncology research universities",
    "Medical research centers",
    "Oncology research companies"
  ],
  "user_reviews": [
    "xT CDx has significantly improved our ability to identify targeted therapies for our patients.",
    "The comprehensive genomic profiling provided by xT CDx has been invaluable in our clinical decision-making process.",
    "We have seen a notable increase in treatment efficacy since implementing xT CDx in our practice.",
    "The integration of xT CDx into our workflow was seamless and has enhanced our diagnostic capabilities.",
    "xT CDx's detailed reporting has streamlined our tumor profiling process, saving valuable time.",
    "The accuracy and depth of information from xT CDx have been crucial in personalizing patient care.",
    "Since adopting xT CDx, our team has been able to offer more precise and effective treatment plans.",
    "The user-friendly interface of xT CDx has made it easier for our staff to interpret complex genomic data.",
    "xT CDx has been a game-changer in our oncology diagnostics, providing insights that were previously unattainable.",
    "The support from Tempus during the implementation of xT CDx was exceptional, ensuring a smooth transition.",
    "xT CDx's comprehensive analysis has led to better patient outcomes in our oncology department.",
    "The ability to detect a wide range of genetic alterations with xT CDx has expanded our treatment options.",
    "xT CDx's companion diagnostic capabilities have been instrumental in guiding our therapeutic decisions.",
    "The detailed tumor mutation profiling from xT CDx has enhanced our understanding of cancer biology.",
    "xT CDx has improved our ability to match patients with appropriate clinical trials, advancing personalized medicine.",
    "The integration of xT CDx has streamlined our laboratory processes, increasing efficiency.",
    "xT CDx's high sensitivity and specificity have reduced the need for additional testing, saving resources.",
    "The comprehensive nature of xT CDx has provided us with a more complete picture of our patients' genetic profiles.",
    "xT CDx has facilitated more informed discussions with patients regarding their treatment options.",
    "The data provided by xT CDx has been instrumental in advancing our research initiatives.",
    "xT CDx's ability to detect rare genetic alterations has opened new avenues for treatment.",
    "The quality of data from xT CDx has enhanced our clinical trial matching process.",
    "xT CDx has been a valuable tool in our efforts to provide precision medicine to our patients.",
    "The detailed reporting from xT CDx has improved our multidisciplinary team's collaboration.",
    "xT CDx's comprehensive analysis has led to more accurate prognostic assessments.",
    "The support from Tempus in training our staff on xT CDx was thorough and effective.",
    "xT CDx has provided us with insights that have significantly impacted our treatment planning.",
    "The implementation of xT CDx has been a positive addition to our oncology practice.",
    "xT CDx's ability to analyze a large number of genes has provided us with a more comprehensive understanding of cancer genetics.",
    "The integration of xT CDx has enhanced our ability to offer personalized treatment plans to our patients.",
    "xT CDx has improved our ability to identify patients who may benefit from targeted therapies.",
    "The data from xT CDx has been instrumental in advancing our clinical research projects.",
    "xT CDx's comprehensive genomic profiling has improved our ability to detect actionable mutations.",
    "The implementation of xT CDx has led to more efficient and effective patient care in our oncology department."
  ],
  "ratings": [
    "4.5/5 (G2)",
    "4.7/5 (Capterra)",
    "4.8/5 (HealthIT.gov)",
    "4.6/5 (SoftwareAdvice)",
    "4.4/5 (TrustRadius)",
    "4.3/5 (Gartner)",
    "4.5/5 (SoftwareReviews)",
    "4.6/5 (GetApp)",
    "4.8/5 (SoftwareAdvice)"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2020",
  "integration_partners": [
    "Illumina",
    "Thermo Fisher Scientific",
    "Agilent Technologies",
    "Qiagen",
    "PerkinElmer",
    "Bio-Rad Laboratories",
    "Roche Diagnostics",
    "Abbott Laboratories",
    "GE Healthcare",
    "Philips Healthcare",
    "Siemens Healthineers",
    "Medtronic",
    "Becton Dickinson"
  ],
  "id": "SW0357",
  "slug": "xt-cdx",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/xt-cdx.json"
  }
}