Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing,  announced a new study as part of the I-SPY 2 trial, sponsored and operated by Quantum Leap Healthcare Collaborative, that will use Signatera, Natera’s personalized and tumor-informed molecular residual disease (MRD) test, to monitor response to neoadjuvant therapy in breast cancer patients across all subtypes.

This prospective study, in which 600 patients will be monitored in real time, will support efforts to establish circulating tumor DNA (ctDNA) as a composite endpoint and generate additional data on post-surgical ctDNA status in patients treated with neoadjuvant therapy. It expands on the existing collaboration with the ISPY-2 consortium that has led to the publication of multiple studies validating the use of Signatera for neoadjuvant response monitoring and predicting recurrence risk, including studies published in Cancer Cell¹ and Annals of Oncology.²

“We are excited to expand our collaboration and help generate a large, prospective dataset to support the incorporation of ctDNA testing into future interventional trials in neoadjuvant breast cancer treatment,” said Laura Esserman, MD, MBA, and Laura van ‘t Veer, PhD, professors at the University of California, San Francisco, and principal investigators of the I-SPY study. “We believe this study, in combination with our prior work in I-SPY 2, will help us understand the role that ctDNA can play in decision making for predicting response and improving our ability to determine who needs less therapy and who needs more. This is of utmost importance to patients.”

“There is a significant unmet need for more accurate tools to enable precision care for patients diagnosed with breast cancer,” said Minetta Liu, MD, chief medical officer of oncology at Natera. “I-SPY 2 serves as an excellent platform to investigate Signatera’s utility in the neoadjuvant and adjuvant settings. This extended collaboration will enhance our understanding of Signatera’s ability to assess therapy response, predict clinical outcomes, and advance a more personalized treatment strategy for patients with breast cancer.”