Tempus xT
Clinical Genetic Test
offered by
GTR Test Accession: Help GTR000558436.11
Last updated in GTR: 2023-08-28
Last annual review date for the lab: 2023-09-01 LinkOut
At a Glance
Predictive; Prognostic; Therapeutic management
Solid tumor; Hematologic neoplasm
Microsatellite Instability; Tumor mutational burden; whole RNA transcriptome
ABCB1 (7q21.12), ABCC3 (17q21.33), ABL1 (9q34.12), ABL2 (1q25.2), ABRAXAS1 (4q21.23), ...
Molecular Genetics - Microsatellite instability testing (MSI): Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
Patients with advanced solid and hematologic malignancies, considered for targeted …
Not provided
Guidance for management; Guidance for management; Guidance for management; ...
Ordering Information
Offered by: Help
Test short name: Help
Manufacturer's name: Help
Tempus Labs, Inc.
Specimen Source: Help
Who can order: Help
  • Licensed Physician
Contact Policy: Help
Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
How to Order: Help
To order the Tempus xT test: 1. Retrieve a Tempus blood, bone marrow or saliva collection kit. All required forms are contained in the box. 2. Complete the Consent Form with the patient. 3. Complete the Requisition Form. Physician and Patient signatures are both required. 4. Complete the Financial Assistance …
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Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Next generation DNA sequencing of 596 genes
Tumor Mutational Burden (TMB) & Microsatellite instability (MSI
Homologous recombination deficiency (HRD) algorithm
    Comment: Add on to xT test, no additional tissue required
    Comment: Add on to xT test, no additional tissue required
    Comment: Add on to xT test, no additional tissue required
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Based on applicable state law
Test strategy: Help
The xT assay is an NGS-based cancer genome profiling test that interrogates 648 cancer-related genes in tumor tissue with a matched normal sample as a reference. The assay interrogates SNVs, CNVs, indels, rearrangements/fusions, TMB and MSI. HRD testing can be added on for patients with matched normal specimen submitted, and … View more
Pre-test genetic counseling required: Help
Post-test genetic counseling required: Help
Recommended fields not provided:
Conditions Help
Total conditions: 2
Condition/Phenotype Identifier
Test Targets
Analytes Help
Total analytes: 3
Analyte Associated Condition
Genes Help
Total genes: 644
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Total methods: 2
Method Category Help
Test method Help
Microsatellite instability testing (MSI)
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Novaseq 6000
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Novaseq 6000
Clinical Information
Test purpose: Help
Predictive; Prognostic; Therapeutic management
Clinical utility: Help
Guidance for management
View citations (1)
  • Comprehensive tumor profiling identifies numerous biomarkers of drug response in cancers of unknown primary site: analysis of 1806 cases. Gatalica Z, et al. Oncotarget. 2014;5(23):12440-7. doi:10.18632/oncotarget.2574. PMID: 25415047.

Guidance for management
View citations (1)
  • Personalized genomic analyses for cancer mutation discovery and interpretation. Jones S, et al. Sci Transl Med. 2015;7(283):283ra53. doi:10.1126/scitranslmed.aaa7161. PMID: 25877891.

Guidance for management
View citations (1)
  • Schwaederle M, Zhao M, Lee JJ, Eggermont AM, Schilsky RL, Mendelsohn J, Lazar V, Kurzrock R. Impact of Precision Medicine in Diverse Cancers: A Meta-Analysis of Phase II Clinical Trials. J Clin Oncol. 2015;33(32):3817-25. doi:10.1200/JCO.2015.61.5997. Epub 2015 Aug 24. PMID: 26304871.

Guidance for management
View citations (1)
  • Jardim DL, Schwaederle M, Wei C, Lee JJ, Hong DS, Eggermont AM, Schilsky RL, Mendelsohn J, Lazar V, Kurzrock R. Impact of a Biomarker-Based Strategy on Oncology Drug Development: A Meta-analysis of Clinical Trials Leading to FDA Approval. J Natl Cancer Inst. 2015;107(11). doi:10.1093/jnci/djv253. Epub 2015 Sep 15. PMID: 26378224.

Guidance for management
View citations (1)
  • Genomic profiling of lung adenocarcinoma patients reveals therapeutic targets and confers clinical benefit when standard molecular testing is negative. Lim SM, et al. Oncotarget. 2016;7(17):24172-8. doi:10.18632/oncotarget.8138. PMID: 26992220.

Guidance for management
View citations (1)
  • Wheler JJ, Janku F, Naing A, Li Y, Stephen B, Zinner R, Subbiah V, Fu S, Karp D, Falchook GS, Tsimberidou AM, Piha-Paul S, Anderson R, Ke D, Miller V, Yelensky R, Lee JJ, Hong DS, Kurzrock R. Cancer Therapy Directed by Comprehensive Genomic Profiling: A Single Center Study. Cancer Res. 2016;76(13):3690-701. doi:10.1158/0008-5472.CAN-15-3043. Epub 2016 May 18. PMID: 27197177.

Guidance for management
View citations (1)
  • Association of Biomarker-Based Treatment Strategies With Response Rates and Progression-Free Survival in Refractory Malignant Neoplasms: A Meta-analysis. Schwaederle M, et al. JAMA Oncol. 2016;2(11):1452-1459. doi:10.1001/jamaoncol.2016.2129. PMID: 27273579.

Guidance for management
View citations (1)
  • Dean A, Byrne A, Marinova M, Hayden I. Clinical Outcomes of Patients with Rare and Heavily Pretreated Solid Tumors Treated according to the Results of Tumor Molecular Profiling. Biomed Res Int. 2016;2016:4627214. doi:10.1155/2016/4627214. Epub 2016 Jul 21. PMID: 27525268.

Guidance for management
View citations (1)
  • Stockley TL, Oza AM, Berman HK, Leighl NB, Knox JJ, Shepherd FA, Chen EX, Krzyzanowska MK, Dhani N, Joshua AM, Tsao MS, Serra S, Clarke B, Roehrl MH, Zhang T, Sukhai MA, Califaretti N, Trinkaus M, Shaw P, van der Kwast T, Wang L, Virtanen C, Kim RH, Razak AR, Hansen AR, Yu C, Pugh TJ, Kamel-Reid S, Siu LL, Bedard PL. Molecular profiling of advanced solid tumors and patient outcomes with genotype-matched clinical trials: the Princess Margaret IMPACT/COMPACT trial. Genome Med. 2016;8(1):109. doi:10.1186/s13073-016-0364-2. Epub 2016 Oct 25. PMID: 27782854.

Guidance for management
View citations (1)
  • Goodman AM, Kato S, Bazhenova L, Patel SP, Frampton GM, Miller V, Stephens PJ, Daniels GA, Kurzrock R. Tumor Mutational Burden as an Independent Predictor of Response to Immunotherapy in Diverse Cancers. Mol Cancer Ther. 2017;16(11):2598-2608. doi:10.1158/1535-7163.MCT-17-0386. Epub 2017 Aug 23. PMID: 28835386.

Guidance for management
View citations (1)
  • Mutation Detection in Patients With Advanced Cancer by Universal Sequencing of Cancer-Related Genes in Tumor and Normal DNA vs Guideline-Based Germline Testing. Mandelker D, et al. JAMA. 2017;318(9):825-835. doi:10.1001/jama.2017.11137. PMID: 28873162.

Guidance for management
View citations (1)
  • Beaubier N, Bontrager M, Huether R, Igartua C, Lau D, Tell R, Bobe AM, Bush S, Chang AL, Hoskinson DC, Khan AA, Kudalkar E, Leibowitz BD, Lozachmeur A, Michuda J, Parsons J, Perera JF, Salahudeen A, Shah KP, Taxter T, Zhu W, White KP. Integrated genomic profiling expands clinical options for patients with cancer. Nat Biotechnol. 2019;37(11):1351-1360. doi:10.1038/s41587-019-0259-z. Epub 2019 Sep 30. PMID: 31570899.

Guidance for management
View citations (1)

Target population: Help
Patients with advanced solid and hematologic malignancies, considered for targeted therapies, unlikely to respond to conventional chemotherapies, or for whom no conventional therapies exist.
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
Tempus uses an internally-built proprietary algorithm based on ACMG/AMP/ASCO guidelines for variant classification. Variants are reported in a tiered structure based on classification and therapeutic actionability. Variants with insufficient evidence to be classified as either pathogenic, likely pathogenic, likely benign or benign are classified as Variants of Uncertain Significance (VUS). … View more

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Not provided.
Recommended fields not provided:
Technical Information
Test Procedure: Help
xT panel sample processing and nucleic acid extraction Expert pathologist assessment of overall tumor content and percent tumor cellularity as a ratio of tumor to normal nuclei verified specimens must meet a 20% threshold. Microdissection is utilized as required to enrich specimens below the 20% threshold. Solid tumor total nucleic … View more
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Single nucleotide variants in actionable genes were detected down to a variant allele fraction (VAF) of 5% with 98.2% Se, over 99.9% Sp in FFPE tissue specimens with at least 20% tumor fraction. Insertions/deletions up to 100bp in size were detected down to 5% VAF with 91.8% Se, 99.9% Sp. … View more
Assay limitations: Help
Tumor required to be at least 20%, but preferably 30% of the sample by a ratio of tumor nuclei to benign nuclei, to include MSI status report. Tumor normal match and 40% tumor content are required for Homologous Recombination Deficiency (HRD) testing.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Software used to interpret novel variations Help

Laboratory's policy on reporting novel variations Help
Tempus reports novel variants if detected somatically and classified as pathogenic, likely pathogenic, or VUS. Tempus reports novel germline variants if pathogenic and likely pathogenic for reportable disease conditions.
Recommended fields not provided:
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
NYS CLEP Approval: Help
Number: 85960
Status: Approved
Additional Information

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.