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Testing resources by NGS, IHC, FISH, and algorithmic testing by cancer type
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.
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Comprehensive Therapy Selection
Streamline your ordering experience and help ensure no critical tests are missed
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CDx Conversion
Learn about the xT CDx order conversion process.
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PD-L1 testing
Optimize PD-L1 testing with four clones tailored to your patient’s cancer type. Automatic selection based on ICD-10 codes or specified diagnostic criteria ensures accurate and relevant immunohistochemical analysis.
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Add-on testing
Expand diagnostic insights with add-on tests: Complement DNA and RNA sequencing with IHC and neuro-oncology assays to gain a comprehensive view of each patient’s cancer profile.
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Algorithmic Tests
Complement DNA and RNA sequencing with advanced algorithms to identify targeted treatment options for each patient’s unique cancer profile.
Comprehensive Therapy Selection (CTS)
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).
Curated Biomarker Tests Based on Patient Cancer Type
| Cancer Type | IHCs / Clinical Biomarker Tests | Algorithmic Tests* |
|---|---|---|
| Biliary tract | HER2 | DPYD, Immune Profile Score (IPS), UGT1A1 |
| Bladder | HER2, PD-L1 (22C3) | DPYD, Immune Profile Score (IPS), UGT1A1 |
| Breast | HER2, PD-L1 (22C3) | HRD, DPYD, IPS, UGT1A1 |
| Cancer of unknown primary | HER2, MMR, PD-L1 (22C3) | DPYD, TO, UGT1A1 |
| Central nervous system | 1p/19q, HER2, MGMT | UGT1A1 |
| Cervical | HER2, PD-L1 (22C3) | DPYD, IPS, UGT1A1 |
| Colorectal | HER2, MMR | DPYD, IPS, UGT1A1 |
| Endometrial | HER2, MMR | DPYD, IPS |
| Esophageal | CLDN18, HER2, MMR, PD-L1 (22C3) | DPYD, IPS, UGT1A1 |
| Gastric | CLDN18, HER2, MMR, PD-L1 (22C3) | DPYD, IPS, UGT1A1 |
| Head and Neck | HER2, PDL1 (22C3) | DPYD, IPS |
| Hepatocellular | HER2 | IPS |
| Melanoma | HER2, PD-L1 (22C3) | IPS |
| Non-small cell lung | HER2, PD-L1 (22C3), PD-L1 (SP142), PD-L1 (SP263), PD-L1 (28-8) | IPS |
| Ovarian | FOLR1, HER2 | DPYD, HRD, UGT1A1 |
| Pancreatic | HER2 | DPYD, PurIST℠, UGT1A1 |
| Prostate | HER2, MMR | |
| Renal | HER2 | IPS |
| Sarcoma | HER2 | UGT1A1 |
| Thyroid | HER2 | DPYD |
| Other | HER2 |
*Algorithmic tests are not included for New York state.
Understanding the conversion process for xT CDx orders
Here's what you need to know about the xT CDx order conversion process:
Why might my order be converted?
When a normal (blood or saliva) sample is received ahead of the tissue sample:
When an xT tumor-only test is ordered and a normal sample is received prior to the tissue (without an order for xF or xF+ liquid biopsy), Tempus treats the order as one for the xT CDx tumor + normal match test.
When xT CDx results are not available:
An order will automatically convert to an xT tumor + normal match (LDT) order if Tempus is unable to deliver results for the initial xT CDx order due to specimen availability or laboratory quality control. This conversion helps avoid what would otherwise be classified as QNS (quantity not sufficient) and prioritizes delivering tissue results whenever possible.
How will these order changes be communicated?
If your order is converted or canceled for any of the reasons mentioned above, the ordering provider will receive an email notification with details about the update.
PD-L1 clones ordered as part of PD-L1 testing
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, the provider determines the PD-L1 stains (clones) based on the patient’s ICD-10 code and associated cancer type as provided to Tempus. 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.
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As shown in the table below, for some cancer types more than one clone is performed (and multiple tests will be billed to the patient’s insurance).The specific scoring method (TPS, CPS, or percentage staining) is also indicated for each PD-L1 stain.
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Patients with non-small cell lung cancer are identified by ICD-10 codes C34.00-C34.92, C80-C80.1, D02.2-D02.22, D14.3-D14.32, D38.1-D38.3, D38.6, Z85.11, Z85.118, Z85.2, Z85.20, or Z85.29*. Ordering physicians will receive four separate IHC stain results (tissue availability permitting).
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If you wish to order staining with different clones than the pre-defined options below, please submit your order and email support@tempus.com with the requested clones to add or remove. Alternatively, visit the Order Tracking page in Hub, select “Modify Order,” then “Add Test” to select specific non-default PD-L1 clones.
| Cancer Type | PD-L1 Stain (clone) | Additional Information |
|---|---|---|
| Breast | PD-L1 22C3 | Tumor Proportion Score (TPS) % ; Combined Positive Score (CPS) |
| Cervical | PD-L1 22C3 | Tumor Proportion Score (TPS) % ; Combined Positive Score (CPS) |
| Esophageal | PD-L1 22C3 | Tumor Proportion Score (TPS) % ; Combined Positive Score (CPS) |
| Gastric/GEJ | PD-L1 22C3 | Tumor Proportion Score (TPS) % ; Combined Positive Score (CPS) |
| Head and Neck | PD-L1 22C3 | Tumor Proportion Score (TPS) % ; Combined Positive Score (CPS) |
| NSCLC | PD-L1 22C3 | Default clone for NSCLC; Tumor Proportion Score (TPS) % ; Combined Positive Score (CPS) |
| PD-L1 28-8 | Tumor Cell Staining (TC) % | |
| PD-L1 SP142 | Tumor Cell Staining (TC)%; Tumor-Infiltrating Immune Cell Staining (IC)% | |
| PD-L1 SP263 | Tumor Cell Staining (TC) % | |
| Other cancer types | PD-L1 22C3 | Tumor Proportion Score (TPS) % ; Combined Positive Score (CPS) |
*Please note the ICD-10 codes may exclude low-specificity ICD-10 codes.
Additional ICD-10 codes may apply for other cancer types.
Add-on testing
Tests available as an add-on to our DNA and RNA sequencing tests.*
IHC testing
MMR Panel
- MSH6, MSH2, MLH1, PMS2
PD-L1
- 22C3, 28-8, SP142, SP263
HER2 (powered by NeoGenomics)
- When HER2 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 Ultra Low assessment for HER2 breast cancer orders with a score of 0.
FOLR1 (powered by NeoGenomics)
- Folate Receptor alpha (FRα) expression.
CLDN18 (powered by NeoGenomics)
- Claudin18 protein expression.
Neuro-oncology testing
1p/19q FISH co-deletion (powered by NeoGenomics)
MGMT methylation (powered by NeoGenomics)
xT CDx tumor + normal DNA seq, xT LDT tumor-only DNA seq, xR RNA seq
Algorithmic Testing
Immune Profile Score (IPS)†
- Prognostic biomarker for immune checkpoint inhibitor candidates.
- IPS 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, HRD 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 HRD 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.
- TO 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℠†
- Identifying patients at elevated risk for toxicity to 5-FU and/or capecitabine.
- PurIST℠ 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.
- UGT1A1 may be ordered as an add-on to xT CDx & xR Combination. The matched normal sample is required for processing.
Learn more about Tempus’ algorithmic tests
†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.
- 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.
- 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.
- 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 AI, 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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