
Natera has announced findings from a study evaluating its personalised tumour-informed molecular residual disease (MRD) test, Signatera, in individuals with soft tissue and bone sarcomas.
The retrospective real-world study, spearheaded by Stanford University School of Medicine, US, is claimed to represent the “largest” sarcoma cohort to date, employing personalised circulating-tumour DNA (ctDNA) monitoring.
It assessed around 200 subjects and more than 2,100 plasma samples across various distinct subtypes.
The study’s key findings indicate that the test showed overall sensitivity to recurrence of 89% and specificity of 100%.
In leiomyosarcoma, which is the most widespread subtype within the cohort, the sensitivity reached 93%, and the specificity of 100%.
Additionally, in patients with leiomyosarcoma who are undergoing progression, ctDNA kinetics during the following therapy were found to be linked to treatment response, with a correlation of 90%.

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By GlobalDataWith over 70 distinct histologic subtypes, sarcomas are stated to be a heterogeneous group of rare cancers.
Natera noted that monitoring treatment response and recurrence is said to be challenging via standard imaging and clinical assessment.
The study supports Signatera’s potential as a monitoring tool for disease recurrence and treatment response.
Building on these outcomes, the research team plans to introduce a prospective study to further validate the clinical utility of the test and investigate its potential to guide treatment decisions and enhance sarcoma care in the future.
Natera oncology general manager and corporate chief medical officer Alexey Aleshin said: “This is the most comprehensive dataset to date on ctDNA monitoring in sarcoma, and it shows excellent performance of Signatera in a difficult-to-monitor cancer.
“The heterogeneity of sarcoma demands a personalised approach, and these results support Signatera’s unique ability to track disease status with precision across a broad spectrum of subtypes.”
Signatera is tailored for each individual, utilising circulating tumour DNA for detecting and quantifying residual cancer, claiming to identify recurrence earlier than standard of care tools.
The test is available for use in both clinical and research applications and is covered by Medicare for various indications. It has been validated clinically across various cancer types and indications.
In January 2025, the company reported new data from the Phase III CALGB (Alliance)/SWOG 80702 study, suggesting the test could play a pivotal role in enhancing treatment outcomes for patients with colorectal cancer.