Tempus Announces the Clinical Launch of its MRD Testing Portfolio

xM MRD and NeXT Personal Dx tests are now available for physicians in the U.S. for early cancer recurrence detection and residual disease monitoring

CHICAGO--(BUSINESS WIRE)--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. The addition of both assays further complements Tempus’ comprehensive testing portfolio.

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. xM was developed using the company’s multimodal database and advanced machine learning algorithms to accurately classify tumor fragments from non-tumor fragments, enhancing the precision of MRD calls. At the 2024 ASCO® Annual Meeting, the company is presenting new data on the xM test with an analytically improved pipeline. The research demonstrates a clinical sensitivity at a landmark of 61.1% and a robust surveillance performance with longitudinal sensitivity of 83.3% and specificity of 89.5% across stage II/III CRC patients. xM MRD results predict disease-free survival (DFS) nearly 5 times stronger compared to standard of care carcinoembryonic antigen (CEA) level (Adj. Hazard Ratio of 9.69 vs. 2.13)

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. Personalis collaborators are also presenting new data on NeXT Personal® at ASCO in breast cancer and immunotherapy monitoring, including two oral presentations.

“MRD testing is the perfect complement to our comprehensive testing portfolio, as we are now equipping physicians with a proactive solution that provides early-stage cancer insights for their patients that is critical to their care,” said Halla Nimeiri, MD, Chief Development Officer at Tempus. “We believe it is important to offer a portfolio of both a rapid, tumor-naïve test and an ultra-sensitive, tumor-informed test so that physicians have optionality in addressing each of their patient’s specific needs.”

About Tempus

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.