Signatera™ Surveillance Testing Identified 100% of Uterine Cancer Recurrences in Advance of Imaging, New Study Shows

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication of a new study in the Journal of Clinical Oncology Precision Oncology (JCO PO), validating Signatera for recurrence monitoring and treatment response assessment in patients with early-stage uterine cancer.

Uterine cancer is the most common gynecologic malignancy in the United States.¹ While most patients are diagnosed with early-stage disease and have a low risk of recurrence, many may have an up to 30% risk of recurrence despite uterine-confined disease.² For patients with early-stage, high or higher-intermediate risk uterine cancer, there are limited tools to individualize recurrence risk and direct therapy.

This recently published, real-world, multi-center, retrospective study analyzed 233 plasma samples from 61 patients with stage I/II uterine cancer who had undergone surgical staging.

Key findings from the study include:

• Signatera positivity was highly prognostic of recurrence in both the postoperative (HR=7.6; p=0.003) and post-definitive therapy (HR=25.4, p=0.0009) settings.
• Signatera status was the most prognostic risk factor, outperforming conventional clinicopathologic factors.
• Among patients with Signatera surveillance testing, 100% tested positive before clinically confirmed recurrence, with a median lead time of 3.1 months. None of the serially Signatera-negative patients experienced recurrence.

Additionally, the study further supports the conclusions of Recio et al. 2024³, which established postoperative and longitudinal Signatera testing as a highly prognostic tool in early-stage uterine cancer.

“In our study, ctDNA positivity was more prognostic of recurrence than any of the traditional risk stratification factors used in practice, and importantly, it is individualized for every patient,” said Michael Toboni, M.D., MPH, gynecologic oncologist at the University of Alabama at Birmingham and principal investigator of the study. “These findings support the potential utility of ctDNA testing as a way to de-escalate and ultimately reduce unnecessary and toxic treatment in early-stage patients.”

“Signatera consistently identified early-stage uterine cancer patients at high risk of recurrence, and predicted recurrences prior to clinical diagnoses,” said Adam ElNaggar, M.D., senior medical director of oncology at Natera. “These insights can inform surveillance strategies and give patients and their care teams more confidence following surgery.”

References

1. CDC, et al. Uterine Cancer Statistics. Centers for Disease Control and Prevention. Accessed September 24, 2025. URL: https://www.cdc.gov/uterine-cancer/statistics/
2. Gordhandas, Sushmita et al. “Current Evidence-Based Systemic Therapy for Advanced and Recurrent Endometrial Cancer.” Journal of the National Comprehensive Cancer Network : JNCCN vol. 21,2 (2023): 217-226. doi:10.6004/jnccn.2022.7254
3. Recio, F., et al. “Post-Surgical ctDNA-Based Molecular Residual Disease Detection in Patients with Stage I Uterine Malignancies.” Gynecologic Oncology, vol. 182, 2024, pp. 63–69. Elsevier, https://doi.org/10.1016/j.ygyno.2023.12.025

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 300 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.

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