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xT CDxxT CDx FDA-Approved Molecular Profiling for Solid Tumors

xRxR Whole Transcriptome RNA Sequencing

DNA and RNA sequencing services that provide a comprehensive view of patients’ genomic profiles, equipping physicians to make informed treatment decisions.

  • xT CDx FDA-approved NGS test for solid tumors

    xT CDx is an FDA-approved 648-gene tissue-based NGS test for molecular profiling of all malignant solid tumors. Leveraging a tumor + normal matched approach, xT CDx includes companion diagnostic (CDx) claims for colorectal cancer (CRC) patients.

  • Professional services 

    The professional services report provides expanded results, including Tumor Mutational Burden (TMB), copy number variations (CNVs), potential germline findings, as well as therapy and trial matching insights.

  • xR RNA sequencing for targeted cancer treatment

    xR offers whole transcriptome RNA sequencing for solid tumors and hematologic malignancies. It provides actionable insights by identifying clinically relevant* fusions across more than 100 targeted genes†, along with altered splicing events such as MET exon 14 and EGFRvIII, all through an unbiased and comprehensive manner.

POWER OF RNA

43.4% of patients were matched to a targeted therapy when DNA seq, RNA seq, and immune biomarker assessment were combined, compared to 29.6% of patients who had a therapy match using DNA seq alone.1,‡

Among patients with identified fusions, 29% more patients were identified with a unique clinically actionable fusion that could be matched to a targeted therapy when RNA seq was incorporated, compared to DNA seq alone.2,‡

SOLID TUMOR + NORMAL MATCH

Solid tumor + normal match testing is a method of parallel DNA sequencing of a solid tumor and normal patient sample (blood or saliva) that distinguishes somatic vs potential germline alterations, aiding in treatment decisions.3,‡

28% reduction in somatic false-positive calls, improving accuracy compared to tumor-only analysis.1,‡

~7% of cancer patients were found to harbor pathogenic or likely pathogenic germline variants across multiple tumor types, and may be indicated for confirmatory germline testing.3,‡

SMART REPORTS

An order summary highlighting biomarkers and clinical trials from multiple Tempus tests placed within a single order—offering a concise overview of patient results.

The xT CDx report features companion diagnostic claims for patients with colorectal cancer (CRC), aiding in the identification of targeted treatment options.

The professional services report provides detailed information, including potential matches to FDA-approved therapies, actionable findings, and a broad range of therapeutic options by leveraging MSK’s OncoKB™ database and NCCN Guidelines®4 to support informed decision-making.

96% of patients matched to a clinical trial when clinical data was combined with Tempus NGS.1,‡

TAILORED TESTING SOLUTIONS

As part of our genomic sequencing portfolio, Tempus provides a comprehensive selection of tests to help empower you to customize treatment for your patients.

  • IHC tests:
    • PD-L1 Clones (22C3, 28-8, SP142, SP263)
    • MMR (MLH1, MSH2, MSH6, PMS2)
    • HER2§
      • Available for all solid tumor types, with reflex testing to ERBB2 FISH in cases of equivocal results (IHC score of 2+)
    • FOLR1 (FRɑ)§
    • CLDN18§
  • Neuro-oncology tests:
    • 1p/19q Co-Deletion§
    • MGMT Promoter Methylation§
  • Algorithmic tests:
    • Immune Profile Score (IPS)
    • Homologous Recombination Deficiency (HRD)
    • Tumor Origin (TO)
    • DPYD
    • UGT1A1
    • PurIST℠

§Powered by NeoGenomics¶While FISH reflex will occur for equivocal IHC results in any solid tumor, it is currently only guideline-supported for select tumor types.5,6,7

Ordering Flexibility

Tempus offers a variety of options to customize molecular profiling for patients.

  • xT CDx is available as a standalone test or in addition to xR RNA seq and xF Liquid Biopsy
  • Auto-conversion from xT CDx to xF Liquid Biopsy in the event of insufficient tissue
  • xT is available for tumor-only testing including hematologic malignancies
  • Streamlined ordering process through Tempus Hub, paper requisition, or directly from your EHR
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Resources

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  • UPCOMING WEBINAR:

    Requisition Form (Standard)

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  • UPCOMING WEBINAR:

    Specimen Guidelines

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xT CDx PERFORMANCE SPECIFICATIONS

TABLE 1: DNA PERFORMANCE SPECIFICATIONS CHICAGO LAB

Proven Accuracy with Validated Performance**
Variant Type Positive Percent Agreement (PPA) Negative Percent Agreement (NPA)
SNVs 99.2% 100.0%
MNV 94.7% 100.0%
Insertion 96.7% 100.0%
Deletion 100% 100.0%
MSI 94.0% 98.0%

**xT CDx’s detection of alterations was compared to an externally validated orthogonal method (NGS assay), and its assessment of MSI status was assessed by comparison to a validated orthogonal method (IHC staining of MLH1, MSH2, MSH6, and PMS2).

Technical Summary

xR LDT PERFORMANCE SPECIFICATIONS

TABLE 2: RNA PERFORMANCE SPECIFICATIONS—CHICAGO LAB
Variant Type Positive Percentage Agreement (PPA) Negative Percentage Agreement (NPA)
Rearrangements/Fusions 100.0% PPA (targeted)
97.0% PPA (untargeted) 		99% NPA (targeted)
99% NPA (untargeted)
Altered Splicing (MET Exon 14) 100.0% PPA 100.0% NPA
Altered Splicing (EGFRvIII) 95.5% PPA 91.3% NPA

TABLE 3: RNA PERFORMANCE SPECIFICATIONS—DURHAM LAB
Variant Type Positive Percentage Agreement (PPA) Negative Percentage Agreement (NPA)
Rearrangements/Fusions 96.8% PPA (targeted)
100.0% PPA (untargeted) 		99.9% NPA (targeted)
99.9% NPA (untargeted)
Altered Splicing (MET Exon 14) 100.0% PPA 100.0% NPA
Altered Splicing (EGFRvIII) 100.0% PPA 100.0% NPA
Validation Summary
Financial Assistance

We help provide access to our tests for all patients in financial need

Approval of the financial assistance application is based on your household income and takes into account all life circumstances. Once a financial assistance application is submitted either online or over the phone, you will receive a decision at the time of submission. 

  • Step 1

    Apply for financial assistance online at access.tempus.com.

  • Step 2

    If approved, you will know immediately about the maximum out-of-pocket cost of your testing.

  • Step 3

    Please contact billing@tempus.com if you are concerned about out-of-pocket costs and would like to discuss your options.

    All U.S.-based patients are eligible to apply for financial assistance regardless of insurance status. For uninsured and international patients, we offer a self-pay option. If you have any questions, please email patients@tempus.com.

Learn more

*Clinically relevant fusions are defined as alterations that are associated with available therapeutic options, prognostic implications, diagnostic relevance, or clinical trial enrollment opportunities for a specific variant identified in a patient’s tumor or hematologic malignancy.

†Examples of targeted genes include but are not limited to: ALK, RET, ROS1, NTRK1/2/3, FGFR1/2/3, NRG1, BRAF, EWSR1, ESR1-CCDC170, MYB-NFIB, PML-RARA, BCR-ABL.

‡This data is derived from LDT testing only.

  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.
  2. Based on a retrospective study involving a cohort of randomly selected patients with tumor types including low grade glioma, sarcoma, glioblastoma, bladder, NSCLC and biliary tract cancer, where a fusion was detected in 2.5% of samples overall (n=2,156/84,938). Michuda J, Park BH, Cummings AL, et al. Use of clinical RNA-sequencing in the detection of actionable fusions compared to DNA-sequencing alone. J Clin Oncol. 2022;40(16_suppl):3077.
  3. Based on a retrospective study involving a cohort of randomly selected patients treated in geographically diverse oncology practices in the US with tumor types including bladder, brain, lung, cholangiocarcinoma, head and neck, breast, ovarian, pancreatic, prostate, endometrial and colorectal. Yap TA, Ashok A, Stoll J, et al. Prevalence of germline findings among tumors from cancer types lacking hereditary testing guidelines. JAMA Netw Open. 2022;5(5):e2213070.
  4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). ©National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed [12.18.24].
  5. Wolff AC, Somerfield MR, Dowsett M, et al. Human epidermal growth factor receptor 2 testing in breast cancer: ASCO-College of American Pathologists guideline update. J Clin Oncol. 2023;41(22):3867-3872.
  6. Bartley AN, Washington MK, Ventura CB, et al. Her2 testing and clinical decision making in gastroesophageal adenocarcinoma: guideline from the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology. Arch Pathol Lab Med. 2016;140(12):1345-1363.
  7. Meric-Bernstam F, Makker V, Oaknin A, et al. Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-PanTumor02 Phase II Trial. J Clin Oncol. 2024;42(1):47-58.

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/

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