Natera announces publication of new study on ability of Signatera test

Natera announced the publication of a new study in Nature Medicine, which demonstrates the ability of the Signatera molecular residual disease, MRD, test to identify patients with stage II-IV colorectal cancer, CRC, who are at an increased risk of recurrence and predict who is likely to benefit from adjuvant chemotherapy, ACT. With this study, data supporting the clinical validity and utility of Signatera has now been published in 40 peer-reviewed publications. In the study, 1,039 patients with stage II-IV resectable CRC were monitored prospectively using the Signatera MRD test. Key takeaways include: Post-surgical MRD status was predictive of chemotherapy benefit. Patients who were MRD-positive four weeks after surgery derived significant benefit from ACT. MRD-negative patients did not see a significant benefit from ACT. Post-surgical MRD status was the most significant prognostic risk factor for recurrence, in a multivariate analysis that accounted for all clinicopathological risk factors currently used for prognostication. Pre-surgical detection rate of 95.9% in patients with pathologic stage II-III disease and 93.1% in patients with stage II-IV disease. Signatera dynamics are indicative of treatment response. Among the MRD-positive patients who were treated with ACT, those with ctDNA clearance had superior DFS compared to those without ctDNA clearance. "This is a practice-changing study for the colorectal cancer community, demonstrating the predictive power of Signatera in the adjuvant setting," said Minetta Liu, M.D., chief medical officer of oncology at Natera. "We are proud to partner with the CIRCULATE consortium and look forward to making Signatera accessible to all colorectal cancer patients in the U.S., Japan and worldwide."