Natera Announces Publication of Signatera™ Validation Study in Testicular Cancer

Largest ever ctDNA study in testicular cancer shows Signatera significantly outperformed standard of care tumor markers

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication of a peer-reviewed manuscript in the Journal of Clinical Oncology - Precision Oncology (JCO PO). The paper features results from a multi-institutional study evaluating circulating tumor DNA (ctDNA) as a prognostic biomarker for patients with germ cell tumors (GCT), including testicular cancer.

Testicular cancer represents approximately 95% of all GCTs¹ and is the most common malignancy in men aged 15-35.² Serum tumor markers (STM) play a central role in the management of testicular cancer, but their utility is limited since they can be normal or falsely elevated in a substantial proportion of patients. While early stages can be cured with surgery alone or with the addition of chemotherapy and/or radiotherapy, a subset of patients may receive chemotherapy that may not be necessary. Having reliable biomarkers to stratify recurrence risk and guide these decisions is a critical challenge in advancing care for this patient population.

This multicenter, retrospective study analyzed 324 plasma samples from 74 patients with testicular cancer, across stages I-III. Signatera was used to assess ctDNA levels before, during and after treatment. Results demonstrated that Signatera-positivity was significantly associated with shorter event-free survival (EFS) in both post-surgical and surveillance settings. By comparison, conventional STMs did not consistently correlate with outcomes. When assessed together during surveillance, ctDNA outperformed STMs in predicting EFS. Key findings include:

• The Signatera-based ctDNA-positivity rate pre-surgery was 91.6% for stage I, and 100% for both stage II and III.
• Post-surgery (<12 weeks), Signatera-positive patients had a significantly shorter EFS compared to Signatera-negative patients (EFS HR: 5.11, p=0.019). In contrast, patients with elevated STMs showed no significant difference in EFS compared to those with normal STM levels (EFS HR: 2.97, p=0.149).
• In the surveillance setting, Signatera-positive patients experienced a significantly shorter EFS compared to Signatera-negative patients (HR: 12.45, p<0.0001). This was not reflected in patients stratified by STM levels (HR: 1.74, p=0.194).

“These findings demonstrate that ctDNA can identify which patients with testicular cancer are at high risk of recurrence or progression,” said Nabil Adra, M.D., associate professor of medicine at Indiana University and principal investigator of the study. “This study gives us new key evidence on the potential of ctDNA to meaningfully improve how we monitor and manage this disease.”

“Testicular cancer is the most common cancer in young men,” said Minetta Liu, M.D., chief medical officer of oncology at Natera. “Serum tumor biomarkers are widely used but often leave gaps in decision-making. These results, which represent the largest published study of ctDNA in testicular cancer to date, highlight the unique value of Signatera to reliably detect molecular residual disease and predict clinical outcomes.”

References

1. SEER Training. Types of Testicular Cancer. SEER Training Modules. National Cancer Institute; accessed September 18, 2025. URL: https://training.seer.cancer.gov/testicular/intro/types.html
2. Ehrlich Y, Margel D, Lubin MA, et al: Advances in the treatment of testicular cancer. Translational Andrology and Urology 4:381-390, 2015

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

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