The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. “It is critical to balance treatment-related benefit with toxicity, and ctDNA assessment by Signatera provides a means by which to predict and evaluate benefit from immunotherapy in melanoma, the deadliest of all skin cancers.” “This collaborative analysis of real-world data supports the prognostic and predictive value of Signatera in the clinical management of melanoma patients after surgery, and those receiving an immune checkpoint inhibitor,” said Minetta Liu, M.D., chief medical officer of oncology at Natera. This illustrates the unmet need for diagnostic tools, like Signatera, to help predict immunotherapy benefit in the adjuvant and metastatic settings and to identify patients early who have resistance to therapy. Current guidelines recommend periodic imaging and clinical assessment to determine therapeutic efficacy 7 however, imaging-based surveillance has limitations. Although the use of immune checkpoint inhibitors has led to significant improvements in overall survival rates for patients with advanced melanoma,2-6 response can be difficult to assess and treatment related toxicity remains a problem. This new study builds upon prior literature supporting the validity and utility of Signatera for pan-cancer immunotherapy monitoring,1 which was the basis for Medicare’s local coverage determination issued in 2021. We hope that this will be explored further in prospective clinical trials.” “Our study shows the potential for a personalized, tumor-informed ctDNA assay to help with making informed and timely treatment decisions for patients with advanced melanoma across treatment settings. “ctDNA is emerging as a potential biomarker for informing adjuvant treatment decisions and assessing treatment response in metastatic disease in real-time,” said Zeynep Eroglu, M.D., medical oncologist in the department of cutaneous oncology at Moffitt Cancer Center and lead author of the study.
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