Updated Data from CIRCULATE-Japan Presented at ESMO 2023 Reinforces Signatera’s Prognostic and Predictive Value in Analysis of 2,500+ Colorectal Cancer Patients

Builds on published evidence with twice as many patients and disease-free survival data extended to 24 months

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced updated data from the GALAXY arm of the CIRCULATE-Japan trial further showcasing the ability of the Signatera™ molecular residual disease (MRD) test to help identify patients with resectable colorectal cancer (CRC) who are at an increased risk of recurrence and predict who are most likely to benefit from adjuvant chemotherapy.

In a presentation today at the 2023 European Society for Medical Oncology (ESMO) Congress in Madrid, Natera and its collaborators shared an expanded GALAXY analysis that builds on results published in January 2023 in Nature Medicine. With 2,625 CRC patients and disease free survival (DFS) assessment at 24 months, this analysis includes more than twice the number of patients and significantly longer follow-up than the previously published 18-month findings.

Key highlights include:

• Circulating tumor DNA (ctDNA) negative patients continued to show exceptional DFS regardless of adjuvant chemotherapy (ACT) treatment.
  • No significant difference in DFS at 24 months was observed for ctDNA negative patients receiving ACT compared to those with no ACT (88.3% DFS v. 89.9%, p-value 0.156).
  • Lack of absolute risk reduction between the two groups further improves on the previously published analysis.

• The presence of post-surgical ctDNA was the most significant prognostic factor for disease recurrence and was predictive of chemotherapy benefit.
  • ctDNA positive patients receiving ACT had significantly higher DFS at 24 months compared to those with no ACT (38.6% DFS v. 16.1%, p-value