Natera to Present New Signatera™ MRD Data at ESMO 2023, Featuring Large, Updated Analysis from CIRCULATE-Japan Study

Presentations include largest analysis from the GALAXY study in colorectal cancer with updated 24-month disease-free survival data, and expanded Signatera readout in rectal cancer

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced it will present new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, at the 2023 European Society for Medical Oncology (ESMO) Congress, taking place Oct. 20-24 in Madrid, Spain.

Natera and its collaborators will present MRD data in a total of seven abstracts, including a mini-oral and several poster presentations. The mini-oral presentation will feature an updated analysis of more than 2,000 patients from the GALAXY observational arm of the CIRCULATE-Japan trial, one of the largest and most comprehensive prospective studies of MRD testing in resectable colorectal cancer (CRC). Other presentations will highlight new Signatera data in rectal cancer, appendiceal adenocarcinoma, hepatocellular carcinoma, renal cell carcinoma, and other solid tumors.

“We look forward to the presentation of updated data from the landmark CIRCULATE-Japan study. With twice the number of patients and significantly longer follow-up, this report reinforces earlier findings published in Nature Medicine that Signatera can help to identify those patients with resectable colorectal cancer who will benefit most from adjuvant chemotherapy,” said Minetta Liu, MD, chief medical officer of oncology at Natera. “Other collaborative presentations at ESMO underscore the utility of MRD testing across multiple indications, including the prediction of clinical outcomes and improved risk stratification for rectal cancer patients treated with neoadjuvant therapy.”

Below is the full list of Natera presentations at ESMO:

Mini Oral Presentation:

Presentation #558MO | CRC | Presenter: Yoshiaki Nakamura, MD, PhD |

Oct 22, 14:45 - 16:20 – Lecture: 15:50-15:55

Circulating tumor (ct)DNA as a prognostic biomarker in patients (pts) with resected CRC: an updated 24 months (mos) disease free survival (DFS) analysis from GALAXY study (CIRCULATE-Japan)

An updated analysis from the CIRCULATE-Japan study builds on the existing evidence from the recently published, prospective, observational GALAXY study, demonstrating the prognostic value of ctDNA in >2,000 CRC patients at 24 months.

Poster Presentations:

Presentation #590P | Rectal Cancer | Oct. 22 | Presenter: Chiara Molinari, PhD

Assessment of ctDNA in pts with locally advanced rectal cancer (LARC) treated with neoadjuvant therapy (NAT)

These new data show that ctDNA monitoring may predict neoadjuvant treatment response and long-term survival outcomes in patients with LARC.

Presentation #649P | Appendiceal Cancer | Oct. 22 | Presenter: Michael G. White, MD, MSc

The genomic landscape of appendiceal adenocarcinoma (AA) revealed by 855 Whole Exome Sequences (WES)

The first large-scale genomic profiling study of AA demonstrates its mutational profile is distinct from rectal and colon cancer, suggesting a different oncologic pathway for this cancer type.

Presentation #1224P | Pan-Cancer | Oct. 22 | Presenter: Yoshiaki Nakamura, MD, PhD

Detection of ctDNA in untreated pts with cancer: implications for early cancer detection (ECD)

This study of treatment-naive cancer patients reveals that tumor-informed ctDNA detection varies by cancer type, stage, and driver mutations. These findings have implications for development of assays for ECD.

Presentation #960P | Hepatocellular Carcinoma | Oct. 23 | Presenter: Maen Abdelrahim, MD, PhD

Personalized ctDNA monitoring for recurrence detection and treatment response assessment in hepatocellular carcinoma (HCC)

These findings support a role for longitudinal ctDNA assessment in identifying early recurrence post-surgical resection in patients with HCC.

Presentation #114P | Biliary Tract Cancer | Oct. 23 | Presenter: Gentry King, MD

Prospective Longitudinal Tumor-Informed ctDNA in Resectable Biliary Tract Cancers (BTC)

In patients with BTC, ctDNA detection may help in evaluating clinical outcomes prior to radiographically evident disease.

Presentation #1908P | Renal Cancer | Oct. 23 | Presenter: Michael Smigelski, MD

Utility of ctDNA testing for MRD detection and treatment response monitoring in pts with renal cell carcinoma (RCC)

This study demonstrates that longitudinal ctDNA monitoring may be predictive of recurrence-free survival post-surgery in patients with RCC.

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).

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 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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