AUSTIN, Texas - Natera, Inc. (NASDAQ: NASDAQ:NTRA), a pioneer in cell-free DNA testing, has announced a partnership with the Fédération Francophone de Cancérologie Digestive and CHU Dijon Bourgogne for the CIRCULATE-PRODIGE-70 study. This phase III clinical trial in France will investigate the use of molecular residual disease (MRD) to guide adjuvant treatment in stage II colorectal cancer (CRC) patients.
The study will assess the benefits of adjuvant chemotherapy (ACT) for stage II CRC patients with detectable circulating tumor DNA (ctDNA) after surgery. Patients testing positive for Signatera MRD will be randomized to receive ACT or observation, while MRD-negative patients will follow standard care. The trial aims to enroll approximately 1,600 patients and anticipates an initial readout in 2025.
CIRCULATE-France is part of a broader effort, including CIRCULATE-Japan and CIRCULATE-US, to evaluate the benefits of MRD-guided treatment. Julien Taieb, MD, PhD, the principal investigator, believes the study could set a new standard for MRD-guided care in stage II CRC, potentially impacting treatment decisions for thousands.
Natera's involvement in the ongoing trial includes their Signatera MRD test, introduced after a methylation-based ctDNA assay was used to screen the first 800 patients. Adham Jurdi, MD, senior medical director of oncology at Natera, expressed confidence in the trial's early progress and the role of personalized MRD testing in improving outcomes for CRC patients in France.
Signatera, a personalized MRD test, detects and quantifies residual cancer using patient-specific circulating tumor DNA. It aims to identify recurrence earlier and optimize treatment decisions. The test is covered by Medicare for various cancers and has been clinically validated across multiple cancer types.
Natera focuses on cell-free DNA testing and aims to integrate personalized genetic testing into standard care to promote health and enable earlier, targeted interventions. The company's tests are supported by over 180 peer-reviewed publications, and it operates certified laboratories in Austin, Texas, and San Carlos, California.
The information for this article is based on a press release statement.
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