Natera Announces Randomized, Signatera™-Guided Interventional Study in Melanoma

First patients enrolled in multi-center trial evaluating MRD-guided escalation for patients with advanced melanoma

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the enrollment of the first patients in a new Signatera-guided trial in melanoma (NCT07504796), sponsored by NYU Langone Health.

The study uses Signatera to guide treatment escalation for patients with advanced or metastatic melanoma, an aggressive form of skin cancer. The current standard of care for these patients is combination immunotherapy until clinical progression. This trial is designed to identify patients who may need earlier intervention by detecting persistent molecular residual disease (MRD) prior to radiographic progression.

After six weeks of first-line treatment (Nivolumab+Relatlimab), patients who are Signatera-positive without radiographic progression will be randomized into one of two different treatment arms: either continuation of first-line treatment until clinical progression; or intensification of first-line treatment with the addition of Ipilimumab. The primary endpoint is progression-free survival.

“This trial takes a more proactive therapeutic approach from the standard of care, which is to treat with immunotherapy until evidence of radiographic progression,” said Janice M. Mehnert, M.D., principal investigator of the study. “By using Signatera to identify patients who do not clear ctDNA early in the treatment regimen, we can act sooner to escalate therapies for those who need it as we aim to improve outcomes.”

“We are pleased to collaborate with NYU Langone Health on this important trial in melanoma,” said Michael Krainock, M.D., Ph.D., MBA, medical director, oncology, Natera. “By integrating Signatera into the trial design, we hope to improve patient selection for therapy escalation – distinguishing those who may be able to continue their current treatment without disease progression from others who need more intensified therapy. If the results are positive, this could be an important step toward changing clinical practice patterns in how we manage melanoma.”

About Natera

Natera is a global leader in cell-free DNA and precision medicine, 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 supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

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