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 factor for recurrence
NCCN guideline for merkel cell carcinoma cites SignateraTM data and now includes positive recommendation for ctDNA monitoring in surveillance
In 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.
For 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
“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
MCC is a rare skin cancer (~3,000 patients diagnosed annually) which disproportionately affects the elderly with most patients diagnosed above age 70.4 MCC has high mortality and a recurrence rate of 40% within 5 years.5
“These guideline changes came faster than expected given the typical timelines to be included,” said
About Signatera
Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in over 100 peer-reviewed papers.
About Natera
Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in
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References
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NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer Version 1.2025. ©
National Comprehensive Cancer Network, Inc. 2025. All rights reserved. AccessedFebruary 7, 2025 . -
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Rectal Cancer Version 1.2025. ©
National Comprehensive Cancer Network, Inc. 2025. All rights reserved. AccessedFebruary 7, 2025 . -
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Merkel Cell Carcinoma Version 1.2025. ©
National Comprehensive Cancer Network, Inc. 2025. All rights reserved. AccessedJanuary 17, 2025 . -
American Cancer Society . Key statistics for Merkel Cell Carcinoma. https://www.cancer.org/cancer/types/merkel-cell-skin-cancer/about/key-statistics.html - McEvoy AM, Lachance K, Hippe DS, et al. Recurrence and Mortality Risk of Merkel Cell Carcinoma by Cancer Stage and Time From Diagnosis. JAMA Dermatol. 2022;158(4):382-389.
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