Testing Resources

This resource page provides a comprehensive overview of testing options, including next-generation sequencing (NGS), pharmacogenomics (PGx), immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), and algorithmic tests, all tailored to specific cancer types. It offers essential tools to support test selection and ordering.

Each Comprehensive Therapy Selection order for solid tumor cancers includes xT CDx (DNA), xR (RNA), and a curated selection of biomarker tests based on your patient’s cancer type (see table below). For hematologic malignancies, a Comprehensive Therapy Selection order will include xT Heme (DNA) and xR (RNA).

Here's what you need to know about the xT CDx order conversion process:

Tempus offers four PD-L1 clones (22C3, 28-8, SP142, SP263).

Tests available as an add-on to our DNA and RNA sequencing tests^§

Pharmacogenomics (PGx) Tests, powered by OneOme

• DPYD Test
  • Covers all tier 1 variant alleles in DPYD pharmacogene, to assess metabolic status. Results can help to identify patients at elevated risk for toxicity to medications such as 5-FU and/or capecitabine.¹
    • No additional specimen required

• UGT1A1 Test
  • Covers key variants in UGT1A1 pharmacogene to assess metabolic status. Results can help to identify patients at elevated risk for toxicity to medications such as irinotecan, sacituzumab govitecan, and/or belinostat.
    • No additional specimen required

• RightMed® Comprehensive
  • Reports metabolic status for 27 genes as well as genotype-predicted interactions for an array of medications
    • No additional specimen required

Clinical Biomarker Tests:

• MMR Panel: MSH6, MSH2, MLH1, PMS2 expression
  • Covers all tier 1 variant alleles in DPYD pharmacogene, to assess metabolic status. Results can help to identify patients at elevated risk for toxicity to medications such as 5-FU and/or capecitabine.¹
    • 6 Additional FFPE unstained slides when DNA mismatch repair (MMR) protein panel IHC is ordered

• PD-L1: PD-L1 expression; IHC clones 22C3, 28-8, SP142, SP263
  • 3 Additional FFPE unstained slides per clone when PD-L1 IHC is ordered

• HER2 (powered by a Tempus partner lab) expression
  • When HER2 IHC is ordered, it will be reflexed to ERBB2 FISH for all solid tumor types in cases of equivocal results (IHC score of 2+).While FISH reflex will occur for equivocal IHC results in any solid tumor, it is currently only guideline-supported for select tumor types^2,3,4
  • Additional analysis to support HER2-ultralow assessment for HER2 breast cancer orders with a score of 0
  • 6-7 unstained slides cut at 4 microns preferred, 5 microns acceptable

• FOLR1 (powered by a Tempus partner lab)
  • Folate Receptor alpha (FRα) expression via IHC
  • 3-4 unstained slides cut at 4 microns preferred, 5 microns acceptable

• CLDN18 (powered by a Tempus partner lab)
  • Claudin-18 expression via IHC
  • 3-4 unstained slides cut at 4 microns preferred, 5 microns acceptable

• c-MET (powered by a Tempus partner lab)
  • c-Met expression via IHC
  • 3-4 unstained slides cut at 4 microns preferred, 5 microns acceptable

• 1p/19q co-deletion (powered by a Tempus partner lab)
  • 4 unstained slides cut at 4 microns preferred, 5 microns is acceptable

• MGMT promoter methylation (powered by a Tempus partner lab)
  • 11 unstained slides cut at 5 or more microns

Algorithmic Tests:

• Immune Profile Score (IPS)^#

  • Prognostic biomarker for immune checkpoint inhibitor candidates
  • May be ordered as an add-on to xT CDx & xR Combination or xT & xR Combination. DNA and RNA seq are required for processing.

• HRD^#

  • Measuring homologous recombination deficiency
  • In Breast and Ovarian cancers, it can be ordered as an add-on to xT CDx & xR Combination. The matched normal sample is required for processing.
  • In other cancer types, RNA seq is required for processing and it may be ordered as an add-on to one of the following combinations:
    • xT CDx & xR Combination
    • xT & xR Combination
    • xR RNA seq

• Tumor Origin^#

  • Refining diagnosis for cancers with uncertain origin
  • May be ordered as an add-on to xT CDx & xR Combination, xT & xR Combination, or xR RNA seq. RNA seq is required for processing.

• PurIST^Ⓡ#

  • Classifying pancreatic ductal adenocarcinoma into one of two subtypes (basal-like or classical)
  • May be ordered as an add-on to xT CDx & xR Combination, xT & xR Combination, or xR RNA seq. RNA seq is required for processing.

Digital Pathology Tests:

• ArteraAI Prostate Test (mHSPC)
  • Providing a 5-year prostate cancer–specific mortality (PCSM) risk for treatment-naïve mHSPC patients
  • May be ordered as an add-on to xT CDx, xT Solid Tumor Only, or xR RNA seq.

1. Pratt VM, Cavallari LH, Fulmer ML, et al. DPYD genotyping recommendations. J Mol Diagn. 2024;26(10):851-863.
2. 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.
3. 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.
4. 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.

^*Algorithmic tests are not included for New York state.
^†Please note the ICD-10 codes may exclude low-specificity ICD-10 codes. Additional ICD-10 codes may apply for other cancer types.
^‡Available as an add-on; not included in the Comprehensive Testing profile.
^§xT CDx tumor + normal DNA seq, xT LDT tumor-only DNA seq, xR RNA seq
^¶Powered by a Tempus partner lab
^#IPS, HRD for non-breast and ovarian cancers, TO and PurIST^Ⓡ are available as add-on tests when xT CDx is ordered with xR RNA sequencing.

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 AI, Inc., Chicago, IL. For the complete xT CDx label, including companion diagnostic indications and important risk information, please visit: http://tempus.com/xt-cdx-label/