Press release
New MultiCenter Prospective Study Demonstrates Signatera’s Clinical Utility in Merkel Cell Carcinoma
Study reports high accuracy of Signatera for surveillance of MCC patients, suggests potential to reduce frequency of surveillance imaging AUSTIN,
About this update from Natera, Inc.
[{"type":"text","content":"\nStudy reports high accuracy of Signatera for surveillance of MCC patients, suggests potential to reduce frequency of surveillance imaging\n\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nNatera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a new study published in the Journal of Clinical Oncology highlighting the utility of its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, for surveillance in Merkel cell carcinoma (MCC). The full study can be found here.\n\n\nMCC is an aggressive skin cancer with high mortality and a recurrence rate of 40% within 5 years.1 MRD testing using a viral antibody is recommended by the National Comprehensive Cancer Network (NCCN)2, but this tumor marker is only present in 52% of patients and has several known limitations3-4. There is an unmet need for improved MRD testing technologies that are applicable to all patients, regardless of their viral status.\n\n\nThis prospective, multicenter, observational study included 319 patients with stage I-IV MCC. Signatera was used to assess ctDNA levels at the time of enrollment, and every 3 months during the surveillance period. Key findings include:\n\n\n\nSignatera showed a test sensitivity of approximately 95% for detecting clinically evident disease at time of enrollment.\n\n\n\nctDNA positivity during surveillance was associated with up to 20 times higher risk of recurrence than persistently ctDNA-negative patients.\n\n\n\nAt 12 months of surveillance, the recurrence-free probability was 9% among patients with a positive ctDNA result at any time, compared with 91% for patients who remained ctDNA-negative.\n\n\n\n“There is a strong need for highly accurate biomarkers in merkel cell carcinoma, an incredibly aggressive and rare form of skin cancer,” said Lisa Zaba, M.D., Ph.D., associate professor of dermatology, director of the MCC multi-disciplinary clinic and member of the supportive oncodermatology group at the Stanford Cancer Center. “Our study shows that a tumor-informed MRD test can inform prognosis and guide surveillance in patients with MCC, regardless of tumor viral status.”\n\n\n“We are encouraged by the excellent performance of Signatera in this study, where high prognostic accuracy was demonstrated, and where we can see the significant clinical utility of MRD testing for detecting recu...