What to know:

• The portfolio features both a tumor-naïve assay and a tumor-informed assay that are designed to help detect residual disease or early cancer recurrence and monitor for immunotherapy treatment response, providing valuable insights to inform patient management strategies.
• 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, and 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.
• A tumor-naive test, like Tempus’ xM for colorectal cancer, does not require tissue, and a tumor-informed assay, like the xM (NeXT Personal® Dx) offered by Tempus, uses whole-genome sequencing of a patient’s tumor to create a personalized panel of up to 1,800 variants.
• Once the tumor signature is established, subsequent turnaround times are excellent, typically under a week, and the ability to access results through the Tempus app on my phone is incredibly convenient.

Tempus Announces the Clinical Launch of its MRD Testing Portfolio

Tempus, a leader in artificial intelligence and precision medicine, today announced the clinical launch of its minimal residual disease (MRD) test portfolio, including Tempus’ xM test and the xM (NeXT Personal® Dx) test by Personalis. The portfolio features both a tumor-naïve assay and a tumor-informed assay that are designed to help detect residual disease or early cancer recurrence and monitor for immunotherapy treatment response, providing valuable insights to inform patient management strategies. Tempus introduced its first MRD test, xM MRD, for research use in January 2024. The rapid, tumor-naïve plasma based test is designed to detect circulating tumor DNA (ctDNA) in the blood of patients with early stage colorectal cancer (CRC) after curative intent surgery. In late 2023, Tempus formed a strategic collaboration with Personalis, Inc., a leader in advanced genomics for precision oncology, to co-commercialize NeXT Personal® Dx, an ultra-sensitive, tumor-informed MRD and monitoring test based on whole genome sequencing offered by Personalis. NeXT Personal® Dx can detect small traces of ctDNA in the blood of patients with early non-small cell lung cancer (NSCLC) and breast cancer following curative intent treatment and can also be used for immunotherapy monitoring in late stage cancer across all solid tumors. The ultra-sensitive, personalized MRD assay identifies up to 1,800 somatic variants unique to a patient’s tumor supporting physicians in making informed, individualized management decisions for patients.
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Portfolio of Minimal Residual Disease & Monitoring

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 is a tumor-naive, finely tuned assay for colorectal cancer. xM (NeXT Personal® Dx) is a tumor-informed, ultra-sensitive whole genome assay for solid tumors. 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. Covered by Medicare for select solid tumor indications* Stage II and III breast cancer, including HR+/HER2-, HER2+ and triple-negative breast cancer (TNBC) in the surveillance setting. Stage I to III non-small cell lung cancer (NSCLC) in the surveillance setting.
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Beyond imaging: Using molecular data to personalize cancer care

A tumor-naive test, like Tempus’ xM for colorectal cancer, does not require tissue. A tumor-informed assay, like the xM (NeXT Personal® Dx) offered by Tempus, uses whole-genome sequencing of a patient’s tumor to create a personalized panel of up to 1,800 variants. This bespoke approach provides ultra-high sensitivity and specificity. Data from studies like NeoADAURA in non-small cell lung cancer (NSCLC) show that ctDNA is a powerful tool for assessing response to neoadjuvant therapy with the use of xM (NeXT Personal® Dx).
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Q&A: Integrating MRD and IO Monitoring with the Tempus portfolio: An oncologist’s perspective

This Q&A article features a discussion between Dr. Allan Espinosa of Arizona Oncology and Dr. Ezra Cohen, Chief Medical Officer at Tempus, exploring the practical application of Tempus’ tumor-naive and tumor-informed MRD and IO treatment monitoring portfolio in clinical practice. What has your experience been with the Tempus IO TRM offering, particularly regarding scheduling, logistics and turnaround time? Once the tumor signature is established, subsequent turnaround times are excellent, typically under a week. Sometimes results are back in time for the visit, and that real-time feedback is very reassuring for both me and the patient. The ability to access results through the Tempus app on my phone is incredibly convenient — I can pull up results live during a patient visit and have the discussion immediately.
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Tempus’ comprehensive MRD testing portfolio

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+ 523 Gene Liquid Assay 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. TEMPUS xF 105 Gene Liquid Assay A ctDNA seq panel that detects oncogenic drivers and resistance mutations, assesses for MSI, and identifies SNVs, INDELs, and CNVs. TEMPUS xM (NeXT PERSONAL®) Tumor-informed Minimal Residual Disease Detection A whole genome assay that enables detection of ctDNA at very low levels to monitor residual disease. In partnership with Personalis.
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