Largest Sarcoma Study to Date with ctDNA Analysis Demonstrates Excellent Performance for Signatera
Stanford-led study included over 2,100 Signatera samples from over 200 sarcoma patients, with overall sensitivity of 89% and specificity of 100%
Leiomyosarcoma, the most common subtype in the cohort, demonstrated sensitivity of 93% and specificity of 100%
Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA and precision medicine, today announced the results of a study led by Stanford University School of Medicine for the evaluation of Signatera, Natera's personalized molecular residual disease (MRD) test, in patients with soft tissue and bone sarcomas. Results of the study (Utilizing Circulating Tumor DNA to Monitor Sarcoma Treatment and Recurrence) were presented at the 2025 Society of Surgical Oncology (SSO) Annual Meeting in March.
With evaluation of approximately 200 patients and more than 2,100 plasma samples across multiple distinct subtypes, this is the largest sarcoma cohort to date using personalized circulating-tumor DNA (ctDNA) monitoring. The study assessed the correlation of Signatera results with imaging, stratified by sarcoma subtype, and followed patients through treatment, disease progression, and surveillance.
Key findings included:
- The results demonstrated excellent test performance, with overall sensitivity to recurrence of 89% and specificity of 100%.
- In leiomyosarcoma, the most common subtype in the cohort, sensitivity was 93%, with specificity of 100%.
- For leiomyosarcoma patients who experienced progression, ctDNA kinetics during subsequent therapy were highly correlated with treatment response (90%).
Sarcomas are a heterogeneous group of rare cancers, with more than 70 distinct histologic subtypes1, making treatment response and recurrence especially difficult to monitor through standard imaging and clinical evaluation. There are approximately 17,000 new cases of sarcoma diagnosed annually in the United States.2
"This data represents a major step forward in understanding how ctDNA monitoring can be applied across a diverse range of sarcoma subtypes," said Beatrice J. Sun, M.D., department of surgery at Stanford University. "With the ability to noninvasively detect disease recurrence and monitor treatment response, Signatera demonstrates the potential to meaningfully improve personalized care for patients with sarcoma."
"This is the most comprehensive dataset to date on ctDNA monitoring in sarcoma, and it shows excellent performance of Signatera in a difficult-to-monitor cancer," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. "The heterogeneity of sarcoma demands a personalized approach, and these results support Signatera's unique ability to track disease status with precision across a broad spectrum of subtypes."
This retrospective real-world study demonstrates the promise of Signatera as a tool to monitor disease recurrence and treatment response. To build on these findings, the team intends to launch a prospective study to further demonstrate Signatera's clinical utility and explore its role in informing treatment decisions and improving future sarcoma care.
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 has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.
About Natera
Natera™ is a global leader in cell-free DNA and genetic 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 supported by more than 250 peer-reviewed publications that demonstrate excellent performance. 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.
References
- Moffitt Cancer Center. What Are the Different Types of Sarcoma? Moffitt Cancer Center, https://www.moffitt.org/cancers/sarcoma/faqs/what-are-the-different-types-of-sarcoma/. Accessed March 31, 2025.
- Sarcoma Alliance. (n.d.). What is sarcoma? Sarcoma Alliance. Retrieved April 28, 2025, from https://sarcomaalliance.org/what-is-sarcoma/
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Investor Relations: Mike Brophy, CFO, Natera, Inc., [email protected]
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., [email protected]