Natera, Inc. announced a collaboration with the Federation Francophone de Cancerologie Digestive and CHU Dijon Bourgogne on the CIRCULATE-PRODIGE-70 study, a randomized, multicenter, prospective phase III clinical trial in France investigating molecular residual disease (MRD)-guided adjuvant treatment in stage II colorectal cancer (CRC) patients. The study's main objective is to determine the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery. Patients who are Signatera MRD-positive will be randomized to receive ACT (FOLFOX 6m) or pursue observation (no chemotherapy).

Patients who are SignateraMRD-negative will be treated according to the standard of care (observation). Approximately 1,600 patients will be tested with Signatera, and a successful study result is expected to pave the way for the adoption and reimbursement of Signatera in France. The initial readout is expected in 2025.

CIRCULATE-France is complementary to the CIRCULATE-Japan and CIRCULATE-US trials. While the Japanese and U.S. trials evaluate the benefit of MRD-guided treatment in stage III and high-risk stage II CRC patients, the French trial is focused on stage II CRC. Natera has joined the study in progress.

A separate methylation-based tumor-naive ctDNA assay, developed in-house by UMR-1138 Centre de Recherche des Cordeliers, was used to screen the first 800 patients for eligibility. The principal investigators elected to add Signatera, Natera's personalized and tumor-informed MRD test, to enhance MRD detection. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions.

The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 50 peer-reviewed papers. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera claims any obligation to update the forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of product offerings, the impact of results of such studies, expectations of the reliability, accuracy and performance of tests, or of the benefits of tests and product offerings to patients, providers and payers.

Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time.