xT CDx

by Tempus Labs  · Based in United States → — AI-Powered Precision Medicine & Genomic Testing
Laboratory Medicine Oncology Pathology
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Contact for pricing; varies by insurance coverage and financial assistance.
Regulatory Status Disclosed

Overview

Tempus xT CDx is a qualitative Next Generation Sequencing (NGS)-based in vitro diagnostic device developed by Tempus Labs. It is designed for comprehensive molecular profiling of all solid malignant tumors, analyzing 648 cancer-related genes. The test detects substitutions (single nucleotide variants and multi-nucleotide variants) and insertion/deletion alterations, as well as microsatellite instability (MSI) status.

Utilizing a tumor-normal matched approach, xT CDx distinguishes somatic alterations from germline variants to provide a high-confidence molecular profile. It includes companion diagnostic (CDx) claims, notably for colorectal cancer (CRC) patients, to identify those who may benefit from specific targeted therapies like Erbitux® (cetuximab) and Vectibix® (panitumumab). Beyond CDx indications, xT CDx provides tumor mutation profiling to assist qualified healthcare professionals in accordance with oncology guidelines for patients with previously diagnosed solid malignant neoplasms.

The assay is performed at Tempus AI, Inc.’s CAP/CLIA certified laboratory in Chicago, IL. Tempus aims to leverage data and artificial intelligence to create intelligent diagnostics, making laboratory tests more accurate, tailored, and personal.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • 648-gene NGS panel for solid tumors
  • Tumor-normal matched DNA sequencing
  • Detection of SNVs, MNVs, and INDELs
  • Microsatellite Instability (MSI) status designation
  • Companion diagnostic (CDx) claims for colorectal cancer
  • Broad tumor profiling for malignant solid tumors
  • AI-powered insights for personalized medicine
  • Integration with NCCN Guidelinesu00ae and OncoKBu2122 database
  • CAP/CLIA certified laboratory testing

Use Cases

  • Molecular profiling of solid malignant tumors
  • Identifying patients eligible for targeted therapies (e.g., Erbituxu00ae, Vectibixu00ae)
  • Informing personalized treatment decisions in oncology
  • Biomarker discovery and clinical development support
  • Diagnostics throughout the drug development process

What Physicians Need to Know

LIS/LIMS Integration
While not explicitly detailed, as a modern laboratory diagnostic tool, xT CDx is expected to integrate with Laboratory Information Systems (LIS) and Laboratory Information Management Systems (LIMS) for streamlined ordering, result reporting, and data management.
Supported Assay Types
xT CDx is an FDA-approved Next Generation Sequencing (NGS)-based in vitro diagnostic device. It detects substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)), insertions and deletions (INDELs) in 648 genes, and microsatellite instability (MSI) status. It utilizes DNA isolated from Formalin-Fixed Paraffin Embedded (FFPE) tumor tissue specimens and matched normal blood or saliva specimens. It also carries companion diagnostic (CDx) claims for colorectal cancer (CRC) patients regarding KRAS and NRAS mutations.
QC/QA Features
The xT CDx assay incorporates four critical quality control (QC) checks throughout its workflow: DNA Extraction (QC1), Library Preparation (QC2), Hybridization Capture (QC3), and Sequencing (QC4). These checks ensure the generation of high-quality data. The assay has demonstrated high concordance with orthogonal testing methods and robust performance in precision testing.
Result Interpretation AI
Tempus, an AI and precision medicine company, utilizes custom software to accurately identify somatic variants in tumors by filtering out germline variants from matched normal DNA. The output of xT CDx includes information derived from the FDA-recognized content of OncoKBu00ae, Memorial Sloan Kettering Cancer Center's precision oncology knowledge base. Results are presented in categories of clinical significance (Level 1 CDx claims, Level 2 Cancer Mutations with Evidence of Clinical Significance, Level 3 Cancer Mutations with Potential Clinical Significance). Tempus also employs AI models like Paige Predict to assess tissue sample viability for genomic testing, enhancing accuracy and tissue conservation.
Critical Value Alerts
While not explicitly termed 'critical value alerts,' the companion diagnostic claims for specific therapies and the categorization of results by clinical significance (Level 1, 2, 3) serve to highlight highly actionable and clinically important findings for physicians.
Instrument Interfaces
xT CDx utilizes the Illumina NovaSeq 6000 platform for sequencing. The test is performed on specific serial number-controlled instruments that are qualified by Tempus Labs, Inc.
Reference Range Intelligence
For genomic profiling, xT CDx provides 'reference range intelligence' through its integration with OncoKBu00ae and the structured categorization of results. This allows for the interpretation of detected variants in the context of their known clinical significance and therapeutic implications.
Turnaround Time Impact
Tempus is committed to providing comprehensive and actionable insights in a timely manner. Turnaround time for Tempus' DNA and RNA sequencing is reported to be less than 14 days, which supports efficient clinical trial eligibility determination and timely treatment decisions.
Physician Tip

When considering xT CDx for your patients, remember it's an FDA-approved, 648-gene NGS test for solid tumor profiling, including companion diagnostic claims for colorectal cancer (CRC) to guide therapies like cetuximab and panitumumab. The tumor + normal matched approach enhances the accuracy of somatic variant identification. The detailed report, leveraging OncoKBu00ae, categorizes findings by clinical significance, aiding in personalized treatment decisions and identifying potential clinical trial matches. For a more comprehensive molecular view, consider combining xT CDx with Tempus' xR RNA sequencing and other algorithmic tests like HRD or IPS, which can provide additional actionable insights.

Tempus xT CDx is performed as a single-site assay at Tempus AI, Inc., utilizing Illumina NovaSeq 6000 sequencers. The platform is designed to be part of Tempus' broader ecosystem, integrating with their intelligent diagnostics, clinical trial matching capabilities, and extensive multimodal data library. This integration leverages AI to provide enhanced insights for both clinical care and therapeutic development. While specific LIS/LIMS integration details are not explicitly stated, such capabilities are generally inherent to modern high-throughput diagnostic laboratories to ensure efficient workflow and data exchange.

Details

Category Lab & Diagnostics, Oncology AI
Pricing Contact for pricing; varies by insurance coverage and financial assistance.
  • Self-pay price is $295 for some Tempus tests, with financial assistance available
  • Tempus accepts all insurance plans and performs a benefits check
  • Patients with Medicare or Medicaid typically pay $0
DeploymentLaboratory-based assay performed at Tempus Labs (Chicago, IL).
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

xT CDx received FDA approval (PMA P210011) on April 28, 2023. It is cleared as a qualitative NGS-based in vitro diagnostic device for detecting SNVs, MNVs, and INDELs in 648 genes, and MSI status, in FFPE tumor tissue and matched normal blood/saliva from solid malignant neoplasm patients. It also has companion diagnostic claims for colorectal cancer.
Integrations
EHR Not specified
Specialties Laboratory Medicine, Oncology, Pathology

What the Web Says

Tempus xT CDx is a comprehensive genomic profiling assay designed for solid tumor analysis, offering insights into various biomarkers including microsatellite instability (MSI), tumor mutational burden (TMB), and specific gene alterations. It is primarily used by oncologists to guide treatment decisions, particularly for targeted therapies and immunotherapies. Reviews highlight its broad genomic coverage and integration with Tempus's broader data platform.

Overall: Positive

Strengths

  • Comprehensive genomic profiling for solid tumors.
  • Detects a wide range of biomarkers (SNVs, Indels, CNVs, fusions, MSI, TMB).
  • FDA-approved for multiple indications, including specific NSCLC and ovarian cancer therapies.
  • Integration with Tempus's AI platform for data analysis and clinical trial matching.
  • Relatively fast turnaround times reported by some users.
  • Clear and actionable reports for treatment guidance.

Limitations

  • Cost can be a barrier for some patients or institutions.
  • Insurance coverage can be complex and vary.
  • Some users report occasional delays in receiving results.
  • Interpretation of complex genomic data can still require specialist expertise.
  • Limited information available from independent tech review sites like G2 or Capterra, as it's a specialized medical product.
  • Potential for information overload due to the breadth of data provided.

Based on reviews from: Tempus.com (product information), FDA approvals and documentation, Clinical oncology publications and studies, Physician forums and discussions (general sentiment), Healthcare IT news and analysis

Last updated: 2026-07-19

Ratings & Reviews

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Press & Coverage

Tempus AI, Inc. (Press Release)
Tempus Receives FDA Approval for Tumor Only xT CDx, Enabling Migration of its Entire DNA Solid Tumor Portfolio
Tempus AI announced FDA approval for a tumor-only indication for its xT CDx next-generation sequencing platform, making it the first laboratory to hold FDA companion diagnostic approval for both tumor-only and tumor-normal comprehensive genomic profiling. This approval allows the test to run without a matched normal sample when unavailable and is expected to provide an estimated $200 ASP benefit starting in 2027.
2026-05
Market Chameleon
FDA Approval for Tempus' Tumor-Only xT CDx Set to Reshape Genomic Profiling in Oncology - Market Chameleon
Tempus AI's xT CDx platform received FDA approval for a tumor-only assay, a significant step that offers clinical flexibility by allowing solid tumor testing without requiring matched normal samples. This regulatory milestone is anticipated to streamline workflows for oncologists and lead to an estimated $200 average selling price benefit for Tempus starting in 2027.
2026-05
360Dx
Tempus AI Nabs FDA Approval for Tumor-Only Indication for xT CDx Assay | 360Dx
Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing platform, a 648-gene tissue-based assay for molecular profiling of solid tumor malignancies. This expands the utility of the test, which also serves as a companion diagnostic for colorectal cancer therapies.
2026-05
Investing.com
Tempus AI receives FDA approval for tumor-only genomic test - Investing.com
Tempus AI announced FDA approval for a tumor-only indication for its xT CDx next-generation sequencing platform, allowing the test to function without a matched normal sample. This makes Tempus the first laboratory with FDA companion diagnostic approval for both tumor-only and tumor-normal comprehensive genomic profiling.
2026-05
Investing.com
Tempus stock rises after FDA approval for tumor-only test - Investing.com
Tempus AI shares rose after the company received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing platform. This approval allows the test to be performed without a matched normal specimen, providing greater flexibility for clinicians.
2026-05
PMC (PubMed Central)
Detecting HLA loss of heterozygosity within a standard diagnostic sequencing workflow for prognostic and therapeutic opportunities - PMC
A study published in PMC details the development and validation of an assay to detect HLA loss of heterozygosity (LOH) within the context of the FDA-approved Tempus xT CDx. This integration aims to enable the interrogation of tumor HLA LOH as a clinical diagnostic for precision oncology.
2024-08
Tempus AI, Inc. (Press Release)
Tempus Announces a Collaboration with Verastem to Develop CDx for First-Ever FDA-Approved KRAS-Mutant Recurrent Low-Grade Serous Ovarian Cancer Combination Treatment
Tempus announced a collaboration with Verastem Oncology to develop a companion diagnostic (CDx) for the first FDA-approved KRAS-mutant recurrent low-grade serous ovarian cancer combination treatment. The Tempus xT CDx assay is being leveraged as an investigational assay in Verastem's global Phase 3 RAMP-301 clinical trial.
2025-05
MDPI
Unraveling Homologous Recombination Deficiency in Ovarian Cancer: A Review of Currently Available Testing Platforms - MDPI
A review article discusses various testing platforms for Homologous Recombination Deficiency (HRD) in ovarian cancer, including Tempus xT CDx. The xT CDx assay targets 648 cancer-related genes and can include a Tempus HRD module to assess HRD status.
2025-05

Videos

Product demos, reviews, and walkthroughs for xT CDx.

View all on YouTube

Frequently Asked Questions

Tempus xT CDx is developed by an AI and precision medicine company, and its proprietary platform incorporates AI algorithms to enhance the analysis of genomic data. This AI integration helps in processing complex Next Generation Sequencing (NGS) data from tumor and matched normal samples, aiming to provide comprehensive and accurate identification of somatic alterations for solid tumor profiling.
xT CDx is an FDA-approved (PMA) in vitro diagnostic device, indicating it has met rigorous regulatory standards for its intended use. As a prescription-use-only test, it must be ordered by a qualified medical professional in accordance with clinical laboratory regulations. While specific AI component compliance details aren't fully elaborated, FDA approval implies the entire system, including any AI used in the diagnostic process, has been validated.
Yes, several other FDA-approved NGS-based comprehensive genomic profiling tests are available, such as FoundationOne CDx, Thermo Fisher's Oncomine Comprehensive, and Illumina's TruSight Oncology 500. While xT CDx distinguishes itself with its AI-powered platform for data analysis and potential clinical trial matching, other tests also offer robust genomic profiling, with varying gene panels and specific companion diagnostic indications.
xT CDx has been granted Advanced Diagnostic Laboratory Test (ADLT) status by CMS, with an initial Medicare reimbursement rate of $4,500. This rate is effective for a nine-month period, after which a new Medicare rate will be established based on the weighted median of private payer amounts. Tempus also offers financial assistance programs and self-pay options for patients.
Limitations of xT CDx include the requirement for FFPE tumor tissue with a minimum tumor percentage (20% for variants, 30% for MSI) and a matched normal sample. It is not intended for germline variant reporting, and genomic findings outside the specific companion diagnostic indications are not prescriptive. While AI aims to improve analysis, physicians should be aware that the interpretation of complex genomic data still requires clinical judgment, and results should be considered within the broader clinical context.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19

Investors who backed xT CDx

Funded through the company that built this tool.

Deerfield Catalyst
T1
New York, United States
Deerfield Catalyst is the early-stage and incubation arm of Deerfield Management, the New York healthcare-only investment platform that manages billions across public…
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