Tempus MRD Testing Portfolio for Life Sciences

Overview

Tempus xM MRD: A tumor-naïve MRD assay that leverages dual methylation- and variant-based workflows to detect ctDNA and call MRD+/-.

 

Tempus xM (NeXT Personal Dx®): A tumor-informed MRD assay that utilizes whole genome sequencing to identify up to 1800 somatic variants.

xM MRD

A liquid-only approach to MRD assessment

 

xM MRD leverages both variant and methylation workflows to call MRD+/-, bringing forward variant-level data about your patient cohort.1

Flowchart illustrating the cTDNA analysis workflow, from sample input to data product stages.Flowchart illustrating the cTDNA analysis workflow, from sample input to data product stages.

Colorectal Cancer (CRC)
Tempus xM is analytically validated2 for early stage (II and III) colorectal cancer and reports on robust variant gene data specific to this indication.2

 

Custom models
For indications outside of colorectal cancer, we are excited to collaborate with biopharma partners and build custom models.

Our science

Longitudinal clinical performance of a novel tumor-naïve minimal residual disease assay in resected stage II and III colorectal cancer patients: A subset analysis from the GALAXY study in CIRCULATE-Japan

xM MRD results predict disease-free survival (DFS) nearly 5 times superior to standard of care carcinoembryonic antigen (CEA) (adjusted hazard ratio 9.69 vs. 2.13).

Kaplan-Meier curves compare disease-free survival for CEA levels and MRD status over time.Kaplan-Meier curves compare disease-free survival for CEA levels and MRD status over time.

Tempus xM (NeXT Personal Dx®)

In partnership with Personalis, Tempus xM (NeXT Personal Dx®) is a tumor-informed approach to MRD assessment that delivers rapid results from one blood draw to help detect residual disease or recurrence. As an ultra sensitive, whole genome assay, this assay enables detection of ctDNA at low levels to monitor residual disease and recurrence. Must be bundled with Tempus products and services.

CLINICAL PERFORMANCE IN NSCLC3

As observed in a study in early stage NSCLC over a 5 year period, 85% of patients who recurred had ctDNA detected, with a median lead time of ~6 months ahead of clinical relapse.*

Two Kaplan-Meier survival curves compare landmark and longitudinal outcomes for negative vs. positive groups.Two Kaplan-Meier survival curves compare landmark and longitudinal outcomes for negative vs. positive groups.

CLINICAL PERFORMANCE IN BREAST CANCER4

As observed in a study in early stage breast cancer over a 6 year period, >99% of patients who recurred had ctDNA detected with a median lead time of ~15 months ahead of clinical relapse.*

Kaplan-Meier curves compare disease-free survival for CEA levels and MRD status over time.Kaplan-Meier curves compare disease-free survival for CEA levels and MRD status over time.

ctDNA Suite

Tempus offers a comprehensive portfolio for MRD and monitoring, which includes a liquid and tissue based assay to support drug development, including patient stratification for future trials, clinical trial design, and treatment response monitoring.

  • Tempus xF+ liquid biopsy
    A ctDNA seq panel that interrogates 523 genes focused on oncogenic and resistance mutations in cell-free DNA (cfDNA) to help clinicians identify treatment opportunities. Identifies SNV, insertions / deletions, CNVs, gene rearrangements from select genes, as well as MSI and bTMB. Measures changes in ctDNA tumor fraction to determine early response to immunotherapy for patients with advanced cancers.

  • Tempus xM MRD
    A tumor-naïve Minimal Residual Disease assay that detects ctDNA in patients following curative-intent treatment to identify patients at high risk of recurrence. Currently available in early stage (II and III) colorectal cancer.

  • Tempus xM (NeXT Personal Dx®) MRD
    A tumor-informed Minimal Residual Disease whole genome assay that enables detection of ctDNA at very low levels to monitor residual disease. In partnership with Personalis.

Explore our full suite of assays for every stage of clinical development ↗︎

References

  1. Dual methylation and variant workflows are utilized at the landmark timepoint (LMT) only, all subsequent timepoints utilize the methylation workflow only.
  2. Nakamura, Y., et al. A tumor-uninformed ctDNA assay detecting MRD in patients with resected stage II or III colorectal cancer predicts recurrence: Subset analysis from the GALAXY study in CIRCULATE-Japan. Presented at ASCO GI 2024.
  3. Black JRM, et al. An ultra-sensitive and specific ctDNA assay provides novel pre-operative disease stratification in early stage lung cancer. Ann Oncol. 2023;34(Suppl):S1294-S1294.
  4. Garcia-Murillas I, et al. Ultra-sensitive ctDNA mutation tracking to identify molecular residual disease and predict relapse in early breast cancer patients. Presented at: ASCO Annual Meeting; June 2, 2024; Chicago, IL.

 

* Data listed is longitudinal data. Longitudinal data encompasses landmark data and refers to a minimum of one MRD test performed post-surgery.

The information on this page is intended for life sciences companies and focuses on research and development applications.

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