Signatera MRD Test Shows Strong Accuracy in Detecting Sarcoma Recurrence

A recent retrospective study highlights the promising performance of Signatera, a personalized molecular residual disease (MRD) test, in monitoring circulating tumor DNA (ctDNA) among patients with soft tissue and bone sarcomas. The study involved analyzing over 2,100 plasma samples from roughly 200 sarcoma patients, comparing ctDNA results with traditional radiographic imaging during treatment, progression, and follow-up.

The findings revealed that Signatera achieved an overall recurrence detection sensitivity of 89% and a perfect specificity of 100%. Specifically, for patients with leiomyosarcoma, these rates were even higher—93% sensitivity and 100% specificity. Notably, among leiomyosarcoma patients experiencing disease progression, there was a 90% correlation between changes in ctDNA levels and treatment response.

Beatrice J. Sun from Stanford University commented on these results, emphasizing that such data represent a significant advance in applying ctDNA testing across various sarcoma subtypes. She highlighted the potential of Signatera to noninvasively detect recurrence and monitor how patients respond to treatment, which could enhance personalized care.

Building on these encouraging results, Natera plans to initiate a prospective trial to better understand how Signatera might influence clinical decision-making and disease management in sarcoma patients. According to Alexey Aleshin, Natera’s Chief Medical Officer, this study provides the most comprehensive data to date on ctDNA monitoring in sarcoma and underscores the importance of a tailored approach given the disease’s heterogeneity.

Signatera is a bespoke assay designed for each patient, using ctDNA to identify residual disease and help guide treatment options.

In addition, preliminary data from a study presented at the 2025 AACR Annual Meeting suggested that ctDNA findings align closely with radiographic assessments in high-risk sarcoma cases. In a small cohort, sensitivity and specificity for detecting recurrence stood at roughly 83% and 90%, respectively. Some patients showed ctDNA positivity weeks before recurrence was evident on imaging, indicating that ctDNA could serve as an early warning tool.

Lead researcher Chahat Rana from UT Southwestern highlighted ctDNA’s potential as a valuable surveillance tool alongside imaging. She also emphasized the need for further research to understand how different sarcoma types shed ctDNA.