First of its Kind Colorectal Cancer Data from Prospective GALAXY Study Released at ESMO; Demonstrates Signatera's Ability to Predict Overall Survival

Shows nearly 10x advantage in overall survival at 36 months based on ctDNA status and affirms Signatera’s ability to predict chemotherapy benefit

Shows a 50% reduction in risk of death for Signatera-positive patients when treated with ACT

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, announced that new data from the GALAXY arm of the ongoing CIRCULATE-Japan trial was released today at the 2024 Congress of the European Society for Medical Oncology (ESMO) in Barcelona, Spain. GALAXY is one of the largest and most comprehensive prospective studies of circulating tumor DNA (ctDNA) testing in resectable colorectal cancer (CRC).

This latest analysis, which will also be published in Nature Medicine on September 16, provides the first evidence of the ability of Signatera-based molecular residual disease (MRD) detection to predict overall survival (OS). The data also demonstrates Signatera’s ability to predict adjuvant chemotherapy (ACT) benefit in resectable CRC, with ctDNA clearance as an indicator of a superior survival benefit compared to no clearance.

In the study, 2,240 patients with stage II–IV CRC were monitored using Signatera after curative-intent surgery with a median follow-up of 23 months. Key takeaways include:

• Signatera status was predictive of overall survival. Signatera-positivity in the post-op MRD window was found to be significantly associated with worse OS compared to Signatera-negative patients (HR: 9.68, p-value