On September 14, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported 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 (Press release, Natera, SEP 14, 2023, View Source [SID1234635175]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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."
About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted four Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions. The test has not been cleared or approved by the US Food and Drug Administration (FDA).