Natera Presents Latest Signatera™ MRD Data in Breast Cancer at SABCS 2021

Rhea-AI Summary

Natera, Inc. (NASDAQ: NTRA) presented key findings at the 2021 San Antonio Breast Cancer Symposium highlighting the use of its Signatera test in high-risk breast cancer patients. The studies indicated that detecting circulating tumor DNA (ctDNA) both pre- and post-surgery was crucial in predicting disease relapse, with ctDNA status being the strongest predictor of patient outcomes. As a custom-built test for monitoring cancer treatment, Signatera has shown significant potential in clinical settings for improving patient care and optimizing treatment strategies.

Positive

• Studies show Signatera's efficacy in predicting relapse in breast cancer patients.
• Detecting ctDNA before and after surgery yields strong predictors of patient outcomes.
• Signatera is gaining clinical support and is part of multiple MRD-guided trials.

Negative

• None.

AUSTIN, Texas, Dec. 9, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in personalized genetic testing and diagnostics, today announced its latest findings presented at the 2021 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas, from December 7-10, 2021. Natera is presenting two studies based on the use of Signatera in high-risk breast cancer patients.

Detection of circulating tumor DNA post neoadjuvant chemotherapy using personalized assay is associated with disease relapse
Poster Presentation: P2-01-06 | Presenter: Elisa Agostinetto, M.D.

In this study, Signatera was used for the detection and monitoring of ctDNA in 44 patients with early breast cancer across all major subtypes, before and after standard neoadjuvant chemotherapy, and then post-surgery with a median clinical follow up of 3 years. The study demonstrated that ctDNA status before surgery and at the last follow up were the strongest predictors of patient outcomes after adjusting for all clinico-pathological risk factors such as stage, histology, tumor size and Ki67 status.

Detection of ctDNA following surgery predicts relapse in breast cancer patients receiving primary surgery
Poster presentation: P2-01-10 | Presenter: Isaac Garcia-Murillas, Ph.D.

This study assessed ctDNA status before surgery, after surgery prior to the start of adjuvant chemotherapy and after adjuvant chemotherapy, in 48 patients with early breast cancer across all major subtypes. ctDNA was detected in 29% of patients after surgery (prior to adjuvant treatment), including 20% in the ER-positive subgroup. Furthermore, results indicated that among patients who were ctDNA-positive after surgery, the majority benefited from adjuvant chemotherapy and did not relapse. Among patients who remained ctDNA-positive after adjuvant treatment, 100% relapsed.

"These studies show that Signatera can help fill in insight gaps that traditional tools, such as scans and blood tests, can't capture in early breast cancer patients," said Angel Rodriguez, M.D., medical director of oncology at Natera. "Not only did we see the efficacy of adjuvant therapy, but the importance of Signatera as a tool to help dramatically improve our understanding of each patient's risk for recurrence, enabling us to more thoroughly monitor their disease and potentially change strategy."

This data is the latest in a fast-growing body of evidence supporting the clinical use of Signatera in breast cancer, across all major subtypes in the neoadjuvant, adjuvant and metastatic settings. Signatera is also supporting multiple MRD-guided prospective clinical trials, where providers can refer eligible patients. More details on Signatera in breast cancer are available here.

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.

About Natera

Natera™ is a leader in personalized genetic testing and diagnostics, transforming how we make critical health care decisions. Our genetic and diagnostic tests help clinicians and their patients protect their health and enable earlier and more targeted interventions that lead to longer, healthier lives. Natera's tests are validated by more than 80 peer-reviewed studies that demonstrate high accuracy, improving patient care outcomes in oncology, women's health 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. 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, 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, or coverage and reimbursement determinations from third-party 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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SOURCE Natera, Inc.

FAQ

What findings did Natera present at the 2021 San Antonio Breast Cancer Symposium?

Natera presented studies demonstrating that its Signatera test effectively detects circulating tumor DNA (ctDNA) in high-risk breast cancer patients, which is a strong predictor of disease relapse.

How does Signatera improve outcomes for breast cancer patients?

Signatera helps in monitoring ctDNA levels, allowing for more tailored treatment strategies and early detection of potential relapses in breast cancer patients.

What is the significance of ctDNA detection in breast cancer treatment?

CtDNA detection provides crucial insights into a patient's risk for recurrence, enabling more informed treatment decisions and improved monitoring strategies.

Is Signatera used in ongoing clinical trials?

Yes, Signatera is supporting multiple MRD-guided clinical trials, expanding its application in breast cancer treatment.

What type of test is Signatera?

Signatera is a custom-built circulating tumor DNA (ctDNA) test designed for treatment monitoring and molecular residual disease (MRD) assessment.