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From development to commercialization, Tempus provides a data-driven approach to CDx partnerships leveraging a broad-panel platform used by thousands of oncologists.

xT CDx: FDA-approved Next Generation Sequencing CDx

xT CDx is a 648-gene tissue-based NGS-based test for molecular profiling of all solid malignant tumors, that also includes companion diagnostic (CDx) claims for colorectal cancer (CRC) patients.

  • Broad tumor profiling for SNVs, MNVs, and INDELs
  • Microsatellite instability (MSI) status designation
  • Tumor normal match
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Companion Diagnostic Indications

Tumor TypeBiomarker(s) DetectedTherapy
Colorectal cancer (CRC)KRAS wild type (absence of mutations in codons 12 or 13)Erbitux® (cetuximab)
Colorectal cancer (CRC)KRAS wild type (absence of mutations in exons 2, 3, or 4) and NRAS wild type (absence of mutations in exons 2, 3, or 4)Vectibix® (panitumumab)
xT CDx Technical Information (FDA Label)

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 Biopharma Partnerships

CDx development as a service

Tempus provides an established, validated platform to help reduce development time and costs associated with companion diagnostic approval.


As one of the leaders pioneering real-world data, Tempus’ robust clinico-genomic database can be used in tandem with trial sequencing data to establish control arms and compare trial data to real-world data.

  • 6M+

    de-identified research records

  • 700K+

    records with matched clinical data linked with genomic information

  • 150K+

    records with whole transcriptome profiles

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Tempus has grown to be one of the largest NGS sequencers of patients’ genomic profiles in the United States.

  • 5K+

    oncologists rely on Tempus as their precision medicine partner

  • ~50%

    of all academic medical centers in the US are connected to Tempus

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Tempus’ established, design-controlled, and validated platform reduces development time and costs for companion diagnostic approval.

  • 96%

    of patients matched to a clinical trial when clinical data was combined with Tempus NGS.1

1 Based on a retrospective study involving a cohort of randomly selected patients with tumor types including brain, breast, colorectal, lung, ovarian, endometrial, pancreatic and prostate cancer. Beaubier N, Bontrager M, Huether R, et al. Integrated genomic profiling expands clinical options for patients with cancer. Nat Biotechnol. 2019;37(11):1351-1360.
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Top pharmaceutical and biotech companies trust Tempus to inform therapy development. We’ve partnered with:

  • 90%

    of the top 20 pharma oncology companies

  • 170+

    biopharma partnerships

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Tempus operates a CAP/CLIA certified laboratory offering NGS services that go beyond traditional lab partnerships, supporting biomarker discovery, clinical development, and diagnostics throughout the drug development process.

  • Whole transcriptome RNA Sequencing
  • Immunotherapy Platform2
  • Companion Diagnostic (CDx) Development
  • Organoid Modeling

2 Gene expression of key immunotherapy targets,HLA typing and loss of heterozygosity, Neoantigen predictions, T-Cell/B-Cell receptor repertoire

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Our Impact

View more resources

    Q&A: Using liquid biopsies to build CDx in pancreatic cancer with Actuate Therapeutics

    Dr. Andrew Mazar of Actuate Therapeutics shares his perspective on liquid biopsy as a tool for CDx and drug development in pancreatic cancer.

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    The value of RNA sequencing in drug discovery

    Learn the value of RNA Sequencing in identifying genetic variants overexpressed in tumors that are measurable by RNA-Seq but not DNA-Seq.

    Read more

    AACR GSK Product Theater

    The Tempus Spotlight Theater this year was on “Delivering on the Promise of Precision Medicine: Leveraging Diagnostics and Data to Drive Next-Generation Drug Development” and was a fireside chat between Kate Sasser, Chief Scientific Officer at Tempus and Anne-Marie Martin, SVP Global Head in the Experimental Medicine Unit at GSK.

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    Using RWD for CDx and drug development

    Leaders from Kronos Bio discuss how they use RWD from heterogeneous sources to strengthen companion diagnostic and drug development strategies.

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    Advancing immuno-oncology with real-world data

    Discover how TScan uses RWD to power companion diagnostic and drug development and ensure the right patients are involved in their clinical studies.

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    Data-driven companion diagnostic development

    At the World Clinical Biomarkers and CDx Summit, biopharma leaders shared how they’re using RWD in oncology to drive CDx and therapeutic innovation.

    Read more

    CDx and cell therapies: using NGS to power R&D

    Learn how A2 Bio uses genomic data to develop companion diagnostics and therapeutics for patients with solid tumors.

    Read more

    Sequencing for development and commercialization

    Learn more about how Tempus’ sequencing services can help your project move forward, consider the experiences of these four organizations, who partnered with Tempus for prospective sequencing for clinical trials.

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    Enhanced biomarker discovery and design

    Combining sequencing, analytics, and data licensing with Tempus allows you to uncover new insights across the research and development spectrum.

    Read more

Learn how multimodal data can support CDx development.

Download our CDx Content Guide

Learn more about partnering with Tempus

This is the future of healthcare.