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 (