Medicare Extends Coverage of Natera’s Signatera MRD Test to Ovarian Cancer and Neoadjuvant Breast Cancer - Seite 2

The coverage decision was based on clinical evidence published in Cancer Cell⁷ from the I-SPY2 trial, which reported on 283 patients and 1,024 plasma samples, with a median of more than 3 years of clinical follow up and a maximum of more than 7.5 years. The study demonstrated that early ctDNA clearance during NAT was a significant predictor of therapy response (p=0.0002), and Signatera negativity after NAT was significantly associated with improved distant recurrence-free survival (DRFS), even in patients with residual cancer burden at surgery (p<0.0001). By contrast, persistent Signatera positivity during and after NAT was significantly associated with therapy non-response and inferior DRFS (p=0.02 to p<0.0001).

“These important Medicare decisions support our ability to personalize disease management for patients with ovarian cancer, the most lethal gynecologic malignancy worldwide, and extend existing coverage in breast cancer to the neoadjuvant setting,” said Minetta Liu, M.D., chief medical officer of oncology at Natera. “Clinical evidence continues to demonstrate the value of Signatera across various settings of disease, which can help clinicians make timely decisions and may improve outcomes for patients. We are incredibly proud of this milestone, and look forward to continuing to work with Medicare to make Signatera more widely accessible for people affected by cancer.”

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 65 peer-reviewed papers.

About Natera

Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated in approximately 175 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit www.natera.com.