New Results From the Landmark Prospective CIRCULATE Trial Expand Clinical Utility of the Signatera® MRD Test in Colorectal Cancer

AUSTIN, Texas, July 2, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced it will present new data on its personalized and tumor-informed molecular residual disease (MRD) assay, Signatera, at the 2021 European Society for Medical Oncology World Congress on Gastrointestinal Cancer (ESMO GI), taking place June 30 - July 3, 2021. Data will be presented in colorectal cancer (CRC) and pancreatic cancer.

Natera will present updated results from the prospective, multi-center, randomized CIRCULATE-Japan trial, the largest MRD-guided study to date in CRC, designed to investigate ctDNA-guided treatment strategies for patients with stage I-IV resected CRC. With follow-up information now available in the first 808 patients in this trial, this readout is multiple times larger than any previous Natera MRD study in CRC, and as such, creates a new benchmark for evaluating test performance.

"We are very encouraged by how quickly we have been able to generate this large, high-quality dataset, and look forward to growing it even further through our collaboration with Natera," said the CIRCULATE-Japan study's Principal Investigator, Dr. Takayuki Yoshino of the National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan. "We believe that personalized MRD testing is the future and will improve treatment decisions for tens of thousands of colorectal cancer patients in Japan and around the world."

"CIRCULATE-Japan is a landmark prospective trial, and based on these strong interim results, we are highly optimistic they will lead to changes in practice guidelines in early-stage colorectal cancer," said Alexey Aleshin, M.D., Natera's vice president of medical affairs, oncology. "At our core, we are a data-driven company, and these data very clearly demonstrate that Signatera can be an important and accurate tool for helping patients avoid unnecessary treatment."

Details about the abstracts are as follows:

Abstract # O-11 | Oral Presentation | Presenter: Hiromichi Shirasu

Monitoring molecular residual disease by circulating tumor DNA in resectable colorectal cancer: Molecular subgroup analyses of a prospective observational study GALAXY in CIRCULATE-Japan

This oral presentation describes an updated interim analysis of the first 808 patients from CIRCULATE-Japan, the largest prospective MRD study to date in CRC. Personalized Signatera assays were performed preoperatively and then serially after surgery. Preoperative MRD was detected in 95% of patients with stage II–III CRC. Longitudinal MRD-positivity was significantly associated with inferior disease-free survival (hazard ratio = 46.8) and Signatera demonstrated a relapse sensitivity of 93.1%. MRD-positivity at 4 weeks after surgery was significantly associated with nodal positivity and MRD-negative patients had remarkably good prognosis, with recurrence-free survival >99% at six months of follow-up, across all stages and regardless of whether adjuvant treatment was administered.

Abstract # 271 | Poster Presentation | Presenter: Maen Abdelrahim, M.D.

Circulating tumor DNA for early relapse detection and monitoring disease status in patients with early-stage pancreatic adenocarcinoma

A prospective study of seven pancreatic adenocarcinoma patients and one ampullary adenocarcinoma patient who were monitored after surgery using Signatera, in addition to blood biomarkers carcinoembryonic antigen (CEA) and cancer antigen 19-9 (CA 19-9) and radiological imaging. MRD-positivity was found to be associated with poorer recurrence-free survival (HR 10.14, p=0.03). MRD findings correlated with, and preceded, imaging results in 100% of patients who relapsed. MRD was found to be a more specific prognostic biomarker compared to CEA and CA 19-9.

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 three 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. This maximizes Signatera's accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions.

Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

About Natera

Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

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, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our 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.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 pr@natera.com

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