Tempus xT Solid Tumor + Normal Match DNA Sequencing

Tempus xR Whole Transcriptome RNA Sequencing

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

xT Solid Tumor + Normal Match is a 648 gene DNA seq panel that reports clinically relevant alterations, immunotherapy biomarkers such as MSI and TMB, HLA Class I genotyping, as well as potential germline findings. Paired normal match sequencing utilizes a patient’s own genome as a comparator in comprehensive genomic panels, resulting in a more personalized sequencing analysis.

xR is a whole transcriptome RNA seq panel for solid tumors and hematologic malignancies that reports clinically relevant1 fusions for more than 100 targeted genes,2 as well as altered splicing events for MET exon 14 and EGFRvIII, in an unbiased and comprehensive manner.

POWER OF RNA

43.4% of patients matched to a targeted therapy when DNA sequencing was combined with RNA-seq and immunotherapy biomarker results.3

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.4

SOLID TUMOR + NORMAL MATCH

Comparing tumor mutations to matched normal samples helps identify true somatic variants with improved accuracy.

28% reduction in somatic false-positive calls, improving accuracy compared to tumor-only analysis.3

SMART REPORTS

Our reports include actionable information based on clinical and molecular findings, expanding clinical trial opportunities for patients.

Tempus incorporates information from MSK’s OncoKB™ database and NCCN Guidelines®5 into clinical reports, providing therapeutic match options.

96% of patients matched to a clinical trial when clinical data was combined with Tempus NGS.3

OPTIONAL ADD-ON TESTS

Employing AI capabilities and leveraging our molecular and clinical database, CAP/CLIA lab, and clinician network, Tempus offers optional add-on testing to provide valuable insights for the treatment of patients with cancer.

IHC Options (Available add on tests to xT DNA seq or xR RNA seq):

  • PD-L1 Clones:
    • 22C3
    • 28-8
    • SP142
    • SP263
  • MMR: MLH, MSH2, MSH6, PMS2
  • Powered by NeoGenomics:
    • HER2 IHC with reflex to ERBB2 FISH for breast and gastric cancers
    • HER2 IHC only for other cancer types
    • FOLR1 (FRɑ)

In accordance with appropriate ASCO/CAP and NCCN guidelines, your order will be reflexed based on the IHC scores listed for the breast or gastric cancer type6-9. HER2 testing is recommended for patients with metastatic colorectal cancer (CRC). CRC specimens are not scored in accordance with CRC guidelines10,11, but instead fall under the HER2 gastric scoring criteria and remain candidates for FISH reflex

Algorithmic Tests (available add-on tests to xT Solid Tumor/Normal Match DNA seq + xR RNA seq without the need for additional tissue):

  • Homologous Recombination Deficiency (HRD)*
  • Tumor Origin (TO)
  • DPYD**
  • UGT1A1**
  • PurISTSM‡

*xT solid tumor + normal match DNA seq required for breast and ovarian (including peritoneal) cancer HRD testing. All other cancers require xR RNA seq.
xR RNA seq required
** xT solid tumor + normal match DNA seq required

TURNAROUND TIME

xT: 9 days from specimen receipt

xR: 10 days from specimen receipt

Ordering Flexibility

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

  • xT and xR may be ordered as standalone tests or in combination
  • xT Solid Tumor/Normal Match and xF/xF+ Liquid Biopsy available as standalone tests or in combination
  • Auto-conversion from xT Solid Tumor/Normal Match to xF Liquid Biopsy in the event of insufficient tissue
  • Streamlined ordering process through Tempus Hub, paper requisition, or directly from your EHR
Access Tempus Hub
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Documents

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  • UPCOMING WEBINAR:

    xT Gene List

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  • UPCOMING WEBINAR:

    Specimen Guidelines

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  • UPCOMING WEBINAR:

    Requisition Form (Standard)

    View
  • UPCOMING WEBINAR:

    Reference Lab IHC Logistics Overview

    View

xT Performance Specifications

TABLE 1: DNA PERFORMANCE SPECIFICATIONS—CHICAGO LAB

Variant Type Limit of Detection Analytical Sensitivity Negative Percentage Agreement
SNVs 5.0% VAF 98.2% >99.0%
Indels 5.0% VAF 91.1% >99.0%
Copy Number Alterations Gain: 30.0% Tumor Purity
Loss: 40.0% Tumor Purity
91.4% >99.0%
Microsatellite Instability 30.0% Tumor Purity 90.5% 98.4%
Rearrangements 30.0% Tumor Purity 90.9% >99.0%

TABLE 2: DNA PERFORMANCE SPECIFICATIONS—DURHAM LAB

Variant Type Limit of Detection Analytical Sensitivity Negative Percentage Agreement
SNVs 5.0% VAF 97.60% >99.0%
Indels 5.0% VAF 91.40% >99.0%
Copy Number Alterations Gain: 33.2% Tumor Purity
Loss: 38.5% Tumor Purity
92.70% >99.0%
Microsatellite Instability 30.0% Tumor Purity 96.20% >99.0%
Rearrangements 30.0% Tumor Purity 96.30% >99.0%

xR Performance Specifications

TABLE 3: RNA PERFORMANCE SPECIFICATIONS—CHICAGO LAB

Variant Class Limit of Detection Positive Percentage Agreement Negative Percentage Agreement
Rearrangements/Fusions 20.0% Tumor Purity 100.0% PPA (targeted)
97.0% PPA (untargeted)
>99% NPA (targeted)
>99% NPA (untargeted)
Altered Splicing (MET Exon 14) 20.0% Tumor Purity 100.0% PPA 100.0% NPA
Altered Splicing (EGFRvIII) 20.0% Tumor Purity 95.5% PPA 91.3% NPA

TABLE 4: RNA PERFORMANCE SPECIFICATIONS—DURHAM LAB

Variant Class Limit of Detection Positive Percentage Agreement Negative Percentage Agreement
Rearrangements/Fusions 20.0% Tumor Purity 96.8% PPA (targeted)
100.0% PPA (untargeted)
99.9% NPA (targeted)
99.9% NPA (untargeted)
Altered Splicing (MET Exon 14) 20.0% Tumor Purity 100.0% PPA 100.0% NPA
Altered Splicing (EGFRvIII) 20.0% Tumor Purity 100.0% PPA 100.0% NPA
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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). ©National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed [4.15.24].
  6. NCCN Clinical Practice Guidelines in Oncology. Breast. Version 2.2024.
  7. 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.
  8. NCCN Clinical Practice Guidelines in Oncology. Gastric. Version 1.2024.
  9. 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.
  10. NCCN Clinical Practice Guidelines in Oncology. Colon Cancer. Version 1.2024
  11. NCCN Clinical Practice Guidelines in Oncology. Rectal Cancer. Version 1.2024.

This is data-driven precision medicine

This is the future of healthcare.