Tempus, a leader in artificial intelligence and precision medicine, announced the addition of a novel MRD assay, xM, to its comprehensive testing solutions. The tumor-naïve plasma based test is available for research use only to detect circulating tumor DNA (ctDNA) in the blood of patients with early stage CRC after surgery.
xM is a liquid biopsy approach to MRD assessment, where no baseline tumor tissue is required. The assay delivers a binary MRD assessment based on both methylation and genomic variant MRD classifiers, while applying algorithms that support filtering of artifacts, clonal hematopoiesis of indeterminate potential (CHIP) and germline variants. It is designed to identify and surveil patients with low levels of circulating tumor DNA who are at risk of recurrence and may benefit from more intensive or novel therapy post-surgery.
At the 2024 ASCO® Gastrointestinal Cancers Symposium, Tempus is presenting research that demonstrates xM’s ability to detect clinical recurrence of early stage CRC with high clinical specificity (94%) and sensitivity (53%) at a landmark single time point 4 weeks after curative surgery. In addition to the data being presented, Tempus is still running further clinical validation studies, through which it expects these numbers could improve over time.
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“Colorectal cancer is the second leading cause of cancer-related deaths worldwide,1 and surgical intervention alone may not be curative for all patients. Emerging data suggests that patients may benefit from diagnostic tests that can detect recurrence with more analytical sensitivity compared to standard surveillance mechanisms like imaging,” said Kate Sasser, PhD, Chief Scientific Officer at Tempus. “We’re excited to introduce a blood-based MRD test that can quickly assess if a patient is at risk of recurrence with high specificity and sensitivity, and xM is a great complement to our growing portfolio of diagnostics as it is a very helpful tool for patients earlier in their treatment journey.”
With the introduction of xM, Tempus will offer two different MRD assays in its comprehensive testing portfolio, including both a tumor-naïve (xM) and tumor-informed test (NeXT). In late 2023, Tempus announced a collaboration with Personalis to co-commercialize NeXT Personal® Dx, its whole genome-based liquid biopsy laboratory developed test (LDT) for detection of MRD and surveillance for risk of recurrence in early stage lung cancer.
SOURCE: BusinessWire
