Algorithmic Tests (IPS, HRD, TO, DPYD, UGT1A1, PurIST)

Tempus offers a suite of AI-driven algorithmic tests designed to help oncologists make more informed treatment decisions for cancer patients. Built on Tempus' molecular and clinical database, CAP/CLIA-certified laboratory, and clinician network, these laboratory developed tests (LDTs) are available as add-ons to existing Tempus genomic profiling tests — requiring no additional tissue from the patient. The platform covers a broad range of clinical needs, from immune checkpoint inhibitor response prediction to pharmacogenomic toxicity risk assessment and tumor subtyping.

Each algorithmic test integrates seamlessly with Tempus' xT CDx, xT, and/or xR sequencing products, enabling clinicians to gain deeper molecular insights from a single sample. The tests span indications including pan-solid tumors, ovarian and breast cancer, colorectal and GI cancers, cancers of unknown primary, and pancreatic ductal adenocarcinoma.

Immune Profile Score (IPS) Test

• The Tempus Immune Profile Score (IPS) is a multimodal biomarker intended as a prognostic indicator for adult patients with metastatic and/or stage IV pan-solid tumor disease who are already candidates for immune checkpoint inhibitor (ICI)-based therapy.
• IPS uses both DNA and RNA sequencing data from the Tempus xT CDx and xR tests to classify patients as IPS-High or IPS-Low.
• Patients classified as IPS-High demonstrated higher real-world overall survival (rwOS) compared to IPS-Low patients when treated with ICI-based regimens.
• IPS may provide enhanced insights complementary to standard biomarker testing.
• Can be ordered as an add-on with the xT CDx & xR combination or xT & xR combination; both DNA and xR RNA sequencing are required for processing.
• Validated performance demonstrated prognostic value across key subgroups: PD-L1 (positive/negative), TMB (high/low), and microsatellite instability status (MSS/MSI-high).

AI-Driven Homologous Recombination Deficiency (HRD) Test

• The Tempus HRD test predicts the probability that a patient's cancer has a phenotype characterized by the inability to repair DNA breaks via the homologous recombination repair (HRR) pathway.
• Available as an add-on for patients tested with Tempus xT CDx, xT, or xR.
• For ovarian and breast cancer, HRD results are based on DNA genome-wide loss of heterozygosity (GWLOH) or evidence of biallelic BRCA1 or BRCA2 loss from the xT CDx test; a matched normal sample is required.
• For all other cancer types, HRD provides a score based on whole transcriptome RNA expression using data from the xR test.
• Can be ordered as an add-on with xT CDx & xR, xT & xR, or xR RNA sequencing alone.
• Provides additional insight into a patient's tumor molecular phenotype on top of standard genomic profiling results.

AI-Driven Tumor Origin (TO) Test

• The Tempus Tumor Origin (TO) test uses tumor RNA expression results to predict the patient's most likely cancer type(s) from 68 possible cancer types and subtypes.
• Developed using a large internal database of clinical and annotated molecular tumor data.
• Intended for use in cancers of unknown primary and cases where available diagnostic information — such as imaging and immunohistochemistry — does not provide a definitive diagnosis.
• When paired with xR, TO results may provide insight into the patient's diagnosis and tumor site of origin to inform patient care and clinical trial eligibility.
• Can be ordered as an add-on with xT CDx & xR, xT & xR, or xR RNA sequencing; xR RNA sequencing is required for processing.

DPYD Pharmacogenomic Test

• The DPYD gene encodes the enzyme dihydropyrimidine dehydrogenase (DPD), a key protein involved in the metabolism of 5-FU and capecitabine.
• The Tempus DPYD test is designed to help physicians identify patients who may be at elevated risk for toxicity and serious adverse effects from 5-FU and capecitabine treatment.
• Particularly applicable in colorectal, breast, pancreatic, and other GI cancers where these agents are considered.
• Can be ordered as an add-on with the xT CDx & xR combination; a matched normal sample is required for processing.
• Covers five SNVs in DPYD genes, providing a more complete patient toxicity risk profile.

UGT1A1 Pharmacogenomic Test

• The Tempus UGT1A1 test identifies patients at elevated risk for toxicity from treatment with irinotecan, sacituzumab govitecan, and/or belinostat.
• Identifies specific genetic polymorphisms in the UGT1A1 gene associated with elevated toxicity risk based on drug labeling.
• A positive test result is returned for patients with the following genotypes: *28/*28, *6/*6, and *6/*28.
• Can be ordered as an add-on with the xT CDx & xR combination; a matched normal sample is required for processing.
• Identifies 5 variants from 3 locations on the UGT1A1 gene for a comprehensive patient profile.

PurIST® Pancreatic Cancer Subtyping Test

• Tempus PurIST® is a laboratory developed test that uses an RNA-based algorithm to classify pancreatic ductal adenocarcinomas (PDAC) into one of two subtypes: basal-like or classical.
• Published literature indicates that patients with the basal subtype have a worse prognosis and are less likely to benefit from FOLFIRINOX therapy compared to classical patients.
• Tempus independently validated the PurIST® algorithm using Tempus RNA sequencing data, demonstrating subtype stratification with distinct survival outcomes and treatment benefit, supporting its integration into routine clinical care for patients with advanced PDAC to inform first-line chemotherapy selection.
• Can be ordered as an add-on with xT CDx & xR, xT & xR, or xR RNA sequencing; xR RNA sequencing is required for processing.
• Provides additional insight into a patient's tumor molecular phenotype on top of genomic profiling results from xR.

All Tempus algorithmic tests are performed at Tempus Labs, Inc. in Chicago, IL, within a CAP/CLIA-certified environment. Each test is designed as an add-on to existing Tempus sequencing orders, eliminating the need for additional tissue collection. The xT CDx platform, which underpins several of these tests, is an FDA-cleared next-generation sequencing (NGS)-based in vitro diagnostic device covering 648 genes and is intended for use as both a companion diagnostic and a comprehensive tumor mutation profiling tool for patients with solid malignant neoplasms.