Tempus xM MRD & Monitoring Portfolio

Covered by Medicare for select indications*

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Overview

Our portfolio of tumor-naive and tumor-informed minimal residual disease (MRD) and monitoring assays provides physicians with valuable patient insights to individualize treatment plans.

 

xM is a finely tuned MRD assay that delivers rapid results from one blood draw to help detect residual disease or recurrence in colorectal cancer.

 

xM (NeXT Personal® Dx)* is an ultra sensitive, whole genome assay that enables detection of ctDNA at very low levels to monitor residual disease and recurrence and IO treatment response monitoring.

xM

xM is a tumor-naive, finely tuned assay for colorectal cancer.

  • Assay design: xM was developed using Tempus’ multimodal database and advanced machine learning algorithms to help accurately detect and classify tumor fragments from non-tumor fragments.

  • Tumor-naive approach: xM is a blood-based assay that can be seamlessly integrated into a patient’s routine blood draw schedule, minimizing the burden to clinical practices.

  • Results: Binary ctDNA status call (detected/not detected) and quantitative results

xM (NeXT Personal® Dx)

xM (NeXT Personal® Dx) is a tumor-informed, ultra-sensitive whole genome assay for solid tumors.

  • Assay design: xM (NeXT Personal® Dx) is an ultra-sensitive personalized MRD assay, capable of detecting molecular markers at concentrations as low as 1.67 parts per million (PPM)1. It utilizes whole genome sequencing to identify up to 1800 somatic variants, filtering out confounding factors such as CHIP and germline variants through a tumor normal matched approach.

  • Tumor-informed approach: xM (NeXT Personal® Dx) utilizes a tumor-informed methodology and provides a personalized assessment of residual disease based on information specific to the patient’s tumor DNA.

  • Results: Binary ctDNA status call (detected/not detected) and quantitative results

  • Medicare coverage: Covered by Medicare for select solid tumor indications.* Stage II and III breast cancer, including HR+/HER2-, HER2+ and triple-negative breast cancer (TNBC), for up to six years in the post-treatment surveillance setting. Stage I to III non-small cell lung cancer (NSCLC) in the surveillance setting.

Assay performance

Detection of ctDNA may function as an early indicator for recurrent malignancy, prior to being seen on radiographic scans.

xM clinical performance in colorectal cancer2
From a subset analysis from the GALAXY study in CIRCULATE-Japan, xM results predict disease-free survival (DFS) nearly 5 times superior to standard of care carcinoembryonic antigen (CEA).

Disease-free survival probability shown by Kaplan-Meier curve for different CEA and MRD groups.Disease-free survival probability shown by Kaplan-Meier curve for different CEA and MRD groups.

xM (NeXT Personal® Dx) 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.**

Kaplan-Meier survival curves depict lower survival rates for positive groups over time.Kaplan-Meier survival curves depict lower survival rates for positive groups over time.

xM (NeXT Personal® Dx) performance in breast cancer4
As observed in a study in early stage breast cancer, 45% of post-surgery samples identified as MRD positive by xM (NeXT Personal® Dx) had ctDNA levels in the ultra-sensitive range falling below 100 PPM.

Graph showing ctDNA Parts-Per-Million progression with a 100 PPM threshold highlighted.Graph showing ctDNA Parts-Per-Million progression with a 100 PPM threshold highlighted.

xM (NeXT Personal® Dx) performance in colorectal cancer5
As observed in a study in colorectal cancer, 87% of patients who recurred were detected within the early landmark window—2 to 8 weeks post-surgery—with 85% detected by week 4.

Kaplan-Meier curve comparing disease-free proportion for negative and positive groups; HR 5.40, p=0.0078.Kaplan-Meier curve comparing disease-free proportion for negative and positive groups; HR 5.40, p=0.0078.

xM (NeXT Personal® Dx) performance in IO monitoring6
Patients with metastatic disease in a pan-cancer cohort receiving IO treatment who saw a molecular response (≥30% decrease in ctDNA by cycle 3) had an overall survival that was more than double that of those without a molecular response.

Kaplan-Meier curves compare PFS and OS for early mIR and no early mIR patient groups.Kaplan-Meier curves compare PFS and OS for early mIR and no early mIR patient groups.

Improving your workflows

Tempus offers a variety of options to customize MRD testing for patients.

Ordering flexibility
Place a single MRD order or a series of longitudinal orders, based on a cadence you determine is medically necessary.

Process diagram comparing APR and NxT Personal flows, detailing visual, touch, and data entry steps.Process diagram comparing APR and NxT Personal flows, detailing visual, touch, and data entry steps.

Mobile phlebotomy
We want to make blood draw services as convenient as possible for your patients who are unable to come into typical clinical/hospital settings. To schedule an appointment, please call 800.739.4137 or utilize click the link below:

Mobile Phlebotomy Request Form →
Scientist in safety glasses pipetting liquid into a test tube during laboratory research.Scientist in safety glasses pipetting liquid into a test tube during laboratory research.

Tempus Hub
Order and view results through our AI-enabled online platform. Paper requisition and EHR ordering are also available.

Two modern smartphones displaying minimalist app interfaces on a clean white background.Two modern smartphones displaying minimalist app interfaces on a clean white background.

Resources

2025 ASCO® Annual Meeting: Colorectal Cancer Data

2025 AACR Annual Meeting: Colorectal Cancer Data

2025 Clinical Cancer Research Publication

2024 ESMO Congress: NSCLC Data

2024 ASCO® Annual Meeting: Breast Cancer Data

2024 ASCO® Annual Meeting: IO Monitoring Data

Financial assistance

We help provide access to our tests for all patients in financial need

 

Approval of the financial assistance application is based on your household income and takes into account all life circumstances. Once a financial assistance application is submitted either online or over the phone, you will receive a decision at the time of submission.

Apply for financial assistance online at access.tempus.com ↗︎

  • If approved, you will know immediately about the maximum out of pocket cost of your testing.

  • Please contact billing@tempus.com if you are concerned about out-of-pocket costs and would like to discuss your options.

All U.S.-based patients are eligible to apply for financial assistance regardless of insurance status. For international patients, we offer a self-pay option. If you have any questions, please email patients@tempus.com. Authorization for Medical Records: Through access.tempus.com, applicants are directed to our Notice and Authorization for Medical Records authorization form. This optional form allows us to request outcomes and other medical records from your health care providers. Please see the form for more information.

References

  1. Northcott J, Bartha G, Harris J, et al. Analytical validation of NeXT Personal ®, an ultra-sensitive personalized circulating tumor DNA assay. Oncotarget. 2024;15:200-218.
  2. Nakamura Y, Kaneva K, Lo C, et al. A tumor-naive ctDNA assay detects minimal residual disease in resected stage II or III colorectal cancer and predicts recurrence: subset analysis from the GALAXY study in CIRCULATE-Japan. Clin Cancer Res. 2025;31(2):328-338.
  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.
  5. Titmuss E, et al. Detection of post-surgical minimal residual disease (MRD) in colorectal cancer; preliminary results from the VICTORI study. Presented at: AACR Annual Meeting; April 29, 2025;Chicago, IL, United States.
  6. Based on a study involving a cohort of randomly selected metastatic patients from 18 different cancer types, who received 1-3 successive lines of ICIs in the context of phase 1 clinical trials. Toledo R, et al. Prognostic and predictive value of ultrasensitive ctDNA monitoring in a metastatic pan-cancer cohort treated with immune checkpoint inhibitors in the context of phase 1 clinical trials. Presented at: ASCO Annual Meeting; June 4, 2024; Chicago, IL.

 

*Covered for Stage II and III breast cancer, including HR+/HER2-, HER2+ and triple-negative breast cancer (TNBC), for up to six years in the post-treatment surveillance setting when coverage criteria are met. Additional criteria and exceptions for coverage may apply.
**Data listed is longitudinal data. Longitudinal data encompasses landmark data and refers to a minimum of one MRD test performed post-surgery.

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