Natera Announces Real-World Data Collaboration with Merck

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that it has entered into an agreement with Merck, known as MSD outside the United States and Canada, under which Merck will utilize Natera’s real-world database (RWD) to advance oncology research.

Natera’s oncology RWD contains de-identified clinical and genomic data from more than 100,000 early- and late-stage patients with cancer who have been tested with Signatera™, the company’s personalized and tumor-informed molecular residual disease (MRD) test. Longitudinal monitoring data is available for the majority of patients, providing an objective measure of molecular response to treatment and connected to a multi-modal database that includes clinical outcomes, genomic profiling, and imaging. Pharmaceutical companies can use Natera’s RWD to strategically advance drug development programs across early-stage and metastatic settings.

“With Signatera being ordered now on a regular basis by over a third of all oncologists in the U.S., Natera is in a unique position to structure and share its real-world experience to inform drug discovery and clinical research,” said John Fesko, Natera’s president & chief business officer.

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 (stage IIb and higher) 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 50 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 by more than 150 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.

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 or our partners’ efforts to develop and commercialize product offerings, 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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