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Largest Sarcoma Study to Date with ctDNA Analysis Demonstrates Excellent Performance for Signatera

Stanford-led study included over 2,100 Signatera samples from over 200 sarcoma patients, with overall sensitivity of 89% and specificity of 100%

articleNatera, Inc.May 5, 20253/company/natera-inc/news/largest-sarcoma-study-date-ctdna-analysis-demonstrates-excellent-performance
Largest Sarcoma Study to Date with ctDNA Analysis Demonstrates Excellent Performance for Signatera

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[{"type":"text","content":"\nStanford-led study included over 2,100 Signatera samples from over 200 sarcoma patients, with overall sensitivity of 89% and specificity of 100%\n\nLeiomyosarcoma, the most common subtype in the cohort, demonstrated sensitivity of 93% and specificity of 100%\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nNatera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the results of a study led by Stanford University School of Medicine for the evaluation of Signatera, Natera’s personalized molecular residual disease (MRD) test, in patients with soft tissue and bone sarcomas. Results of the study (Utilizing Circulating Tumor DNA to Monitor Sarcoma Treatment and Recurrence) were presented at the 2025 Society of Surgical Oncology (SSO) Annual Meeting in March.\n\nWith evaluation of approximately 200 patients and more than 2,100 plasma samples across multiple distinct subtypes, this is the largest sarcoma cohort to date using personalized circulating-tumor DNA (ctDNA) monitoring. The study assessed the correlation of Signatera results with imaging, stratified by sarcoma subtype, and followed patients through treatment, disease progression, and surveillance.\n\nKey findings included:\n\n\nThe results demonstrated excellent test performance, with overall sensitivity to recurrence of 89% and specificity of 100%.\n\n\nIn leiomyosarcoma, the most common subtype in the cohort, sensitivity was 93%, with specificity of 100%.\n\n\nFor leiomyosarcoma patients who experienced progression, ctDNA kinetics during subsequent therapy were highly correlated with treatment response (90%).\n\n\nSarcomas are a heterogeneous group of rare cancers, with more than 70 distinct histologic subtypes1, making treatment response and recurrence especially difficult to monitor through standard imaging and clinical evaluation. There are approximately 17,000 new cases of sarcoma diagnosed annually in the United States.2\n\n“This data represents a major step forward in understanding how ctDNA monitoring can be applied across a diverse range of sarcoma subtypes,” said Beatrice J. Sun, M.D., department of surgery at Stanford University. “With the ability to noninvasively detect disease recurrence and monitor treatment response, Signatera demonstrates the potential to meaningfully improve personalized care for patients with sarcoma.”\n\n“T...

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