Phase III CIRCULATE Trial: Signatera™ for Stage II CRC in France

Natera, Inc., a prominent company in the field of cell-free DNA testing, has recently announced a significant collaboration with the Fédération Francophone de Cancérologie Digestive and CHU Dijon Bourgogne. They are working together on the CIRCULATE-PRODIGE-70 study, which is a phase III clinical trial taking place in France. This study is particularly focused on the role of molecular residual disease (MRD) in guiding adjuvant treatment for patients with stage II colorectal cancer.

The primary goal of the research is to ascertain the efficacy of adjuvant chemotherapy in post-surgery patients who have detectable circulating tumor DNA. The study will involve approximately 1,600 individuals, who will be tested using Natera's Signatera technology. The results are anticipated to be instrumental in the adoption and reimbursement of Signatera in France, with the initial findings expected in 2025.

This French trial is in addition to the CIRCULATE-Japan and CIRCULATE-US trials, which are examining the benefits of MRD-guided treatment for stage III and high-risk stage II CRC patients. The French study, however, is specifically targeting stage II CRC patients.

Julien Taieb, a leading figure in gastroenterology and gastrointestinal oncology, emphasized the importance of this study, stating that France sees over 44,000 individuals affected by CRC each year. He believes that the study could set a new standard for MRD-guided care, potentially benefiting thousands of patients by improving treatment decisions.

Natera has joined an ongoing study, where an initial screening of 800 patients was conducted using a different ctDNA assay. The decision to incorporate Signatera, Natera's personalized MRD test, was made to enhance the detection capabilities of MRD.

Adham Jurdi, a senior medical director at Natera, expressed his enthusiasm for the trial, highlighting the importance of personalized MRD testing in various clinical settings for colorectal cancer. He anticipates that the study will contribute to improved survival and outcomes for French CRC patients.

Signatera is a personalized molecular residual disease test that is tailored to each individual's cancer profile. It uses circulating tumor DNA to detect residual cancer in the body, identify early recurrence, and assist in making more informed treatment decisions. The test is available for clinical and research purposes and is covered by Medicare for several types of cancer.

Natera is a global leader in cell-free DNA testing, with a focus on oncology, women's health, and organ health. The company is committed to integrating personalized genetic testing into standard care to promote earlier and more targeted interventions, leading to healthier and longer lives. Natera's tests are supported by over 180 peer-reviewed publications that demonstrate their high accuracy. The company operates certified laboratories in Texas and California, adhering to stringent clinical laboratory standards.