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NCCN Strengthens Guidance on ctDNA in Colon Cancer, Rectal Cancer, and Merkel Cell Carcinoma
National Comprehensive Cancer Network® (NCCN®) Guidelines for colon and rectal cancer were updated to include ctDNA as a prognostic marker and high risk
About this update from Natera, Inc.
[{"type":"text","content":"\nNational Comprehensive Cancer Network® (NCCN®) Guidelines for colon and rectal cancer were updated to include ctDNA as a prognostic marker and high risk factor for recurrence\n\n\nNCCN guideline for merkel cell carcinoma cites SignateraTM data and now includes positive recommendation for ctDNA monitoring in surveillance\n\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nNatera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today commented on recent updates by the NCCN on circulating tumor DNA (ctDNA) molecular residual disease (MRD) testing in the Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for colon cancer, rectal cancer, and merkel cell carcinoma (MCC).\n\n\nIn its updated guidelines for colon cancer1 and for rectal cancer2, NCCN now includes ctDNA as a high risk factor for recurrence in the adjuvant setting, recognizing its prognostic value. This represents a significant step forward as it’s the first time the committee has formally recognized ctDNA as being prognostic. The guidelines remain cautious about ctDNA for surveillance, as expected. The NCCN finalized these updates before data from the phase III CALGB (Alliance) / SWOG 80702 study were presented at ASCO GI in January, supporting the predictive nature of Signatera in the adjuvant setting.\n\n\nFor MCC, the updated NCCN guidelines state that “ctDNA can assess disease burden in both virus-positive and virus-negative MCC and typically becomes positive prior to or at the time of a clinically evident recurrence. For surveillance, this test is often obtained every 3 months.”3 In addition, the guideline specifically references a Signatera publication with data from a prospective multicenter study published in 2024 in the Journal of Clinical Oncology (JCO). The study demonstrated excellent performance of Signatera, with 95% detection at time of enrollment and 20x higher risk of recurrence among patients who were persistently Signatera positive. Natera believes this positive update on MCC can set a precedent for the important role of ctDNA testing across other indications.\n\n\n“Signatera tumor-informed ctDNA testing is a highly accurate and prognostic biomarker for surveillance of high- and low-risk patients with MCC to help determine imaging frequency,” said Lisa Zaba, M.D., Ph.D., associate professor of dermatology, director of the MCC m...