Natera announces publication of Signatera validation study

Natera (NTRA) 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. 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 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, Signatera-positive patients had a significantly shorter EFS compared to Signatera-negative patients. In contrast, patients with elevated STMs showed no significant difference in EFS compared to those with normal STM levels. In the surveillance setting, Signatera-positive patients experienced a significantly shorter EFS compared to Signatera-negative patients. This was not reflected in patients stratified by STM levels.