New Signatera™ MRD Data in Gastrointestinal Cancers to be Presented at the ASCO GI Symposium 2023

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing, today announced that new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, will be presented at the American Society of Clinical Oncology's 2023 Gastrointestinal Cancers Symposium (ASCO GI), taking place January 19 – 21, 2023 in San Francisco, California. The presentations will highlight findings on the utility of Signatera for MRD assessment in colorectal (CRC), esophageal, gastric and anal cancers, in a total of five presentations.

“On the heels of the groundbreaking CIRCULATE-Japan results just released, we are excited to share additional data further underscoring the real-world utility of Signatera in GI cancers,” said Solomon Moshkevich, general manager of oncology at Natera. “This data continues to reinforce the value of personalized and tumor-informed MRD testing across different treatment settings.”

Stacey A. Cohen, M.D., of the University of Washington and the Fred Hutchinson Cancer Center, will deliver an oral presentation on a real-world study of 14,425 patients with stage I-III CRC after surgery. The preliminary findings from this study suggest that though cfDNA concentration is significantly increased in the first 2-4 weeks, Signatera detection rates remained consistent with those of weeks 4-8, indicating that standard MRD testing windows could start two weeks after surgery.

“Through our study, we’ve shown for the first time in a large, real-world setting that MRD testing with Signatera could be performed starting at 2 weeks, without compromising test sensitivity,” said Dr. Cohen, author and presenter of the study. “These findings highlight the potential for oncologists and patients to benefit from earlier opportunities to consider Signatera to inform personalized treatment for patients with colorectal cancer.”

The full list of Signatera presentations and activities during ASCO GI is below.

Oral presentations

• Jan. 21, 11:10 AM PT | Stage I-III colorectal cancer (Oral Presentation)
  
  Presenter: Stacey A. Cohen, M.D., University of Washington and the Fred Hutchinson Cancer Center
  
  Kinetics of postoperative circulating cell-free DNA and impact on minimal residual disease detection rates in patients with resected stage I-III colorectal cancer

• Jan. 21, 9:00 AM PT | Anal squamous cell carcinoma (Oral Presentation)
  
  Presenter: Janet Alvarez, M.D., Memorial Sloan Kettering Cancer Center
  
  Circulating Tumor DNA (ctDNA) Provides a Rapid and Early Response Assessment in Patients with Anal Cancer Treated with Definitive Chemoradiation

This oral presentation in Anal cancer follows a separate study published recently in The Oncologist, which demonstrated Signatera’s performance in over 250 patients with anal squamous cell carcinoma. See below for further details.

Posters and Industry Session

• Jan. 19, 12:00 PM PT | Stage I-III Esophagogastric Cancers (Poster)
  
  Presenter: Eric Lander, M.D., Vanderbilt University
  
  Circulating tumor DNA as a marker of recurrence risk in locoregional esophagogastric cancers with pathologic complete response

• Jan. 19, 12:00 PM PT | Metastatic esophageal cancer (Poster)
  
  Presenter: Rutika Mehta, M.D., Moffitt Cancer Center
  
  Circulating tumor DNA (ctDNA) informs clinical practice in patients with recurrent/metastatic gastroesophageal cancers

• Jan. 19, 12:00 pm PT | Locally advanced esophageal, gastroesophageal junctional, or gastric cancer (Poster)
  
  Presenter: Lei Deng, M.D., Roswell Park Comprehensive Cancer Center
  
  Feasibility and dynamics of preoperative circulating tumor DNA in gastroesophageal cancer patients receiving preoperative treatment

• Jan 19, 12:15 PM PT | (Industry Expert Theater)
  
  Presenter: Adham Jurdi, M.D., medical director of oncology, Natera, Inc.
  
  Applications of personalized ctDNA testing to optimize treatment decisions in patients with GI cancers
  
  Dr. Jurdi will discuss Natera’s growing library of clinical evidence within GI cancers as well as recent data from the ongoing CIRCULATE-Japan trial published in Nature Medicine on Jan 16th, 2023.

Additional data recently published on Anal squamous carcinoma (SCCA)

A recent study published in The Oncologist highlights Signatera’s utility in anal squamous cell carcinoma (SCCA). The paper reports results from a real-world study of 251 patients (817 plasma samples) with stage I-IV SCCA who were monitored longitudinally after completion of definitive treatment. In a subset of patients with complete clinical follow-up, ctDNA-positivity at any time after definitive treatment was associated with significantly shorter disease-free survival. Among the ctDNA-negative patients, all except one remained disease free on imaging (NPV 95.7%). Additionally, analysis of whole exome sequencing data from all 251 patients found significant genomic heterogeneity, further highlighting the value of a personalized and tumor-informed approach to ctDNA testing.

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. 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.

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 100 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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