Testing Resources

This resource page provides a comprehensive overview of testing options, including next-generation sequencing (NGS), 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). Selection depends on the patient's cancer type as determined by the ‘Current Diagnosis’ checkboxes (on paper requisitions) or ICD-10 codes.

When PD-L1 is ordered, Tempus determines the PD-L1 stains (clones) based on the patient’s ICD-10 code and associated cancer type as provided to Tempus (see the table below). If no ICD-10 code is provided, or if the provided code is not listed, Tempus defaults to using the 22C3 clone to fulfill the order unless another clone is specified.

Tests available as an add-on to our DNA and RNA sequencing tests.*

IHC testing:

• MMR Panel: MSH6, MSH2, MLH1, PMS2 expression
  • 6 Additional FFPE unstained slides when DNA mismatch repair (MMR) protein panel IHC is ordered
• PD-L1: PD-L1 expression; 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^1,2,3
  • 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
  • 3-4 unstained slides cut at 4 microns preferred, 5 microns acceptable
• CLDN18 (powered by a Tempus partner lab)
  • Claudin-18 expression
  • 3-4 unstained slides cut at 4 microns preferred, 5 microns acceptable
• c-MET (powered by a Tempus partner lab)
  • c-Met expression
  • 3-4 unstained slides cut at 4 microns preferred, 5 microns acceptable

Neuro-oncology testing:

• 1p/19q co-deletion (powered by a Tempus partner lab)
• MGMT promoter methylation (powered by a Tempus partner lab)

*xT CDx tumor + normal DNA seq, xT LDT tumor-only DNA seq, xR RNA seq

• 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.

• DPYD

  • Identifying patients at elevated risk for toxicity to 5-FU and/or capecitabine
  • May be ordered as an add-on to xT CDx & xR Combination. The matched normal sample is required for processing.

• UGT1A1

  • Identifying patients at elevated risk for toxicity to irinotecan, sacituzumab govitecan, and/or belinostat
  • May be ordered as an add-on to xT CDx & xR Combination. The matched normal sample is required for processing.

1. 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.
2. 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.
3. 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.