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
Natera, 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).
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 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.
"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 multi-disciplinary clinic and member of the supportive oncodermatology group at the Stanford Cancer Center.
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 Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology for Natera. "The inclusion of ctDNA testing in NCCN guidelines for these histologies is another step toward more personalized care for patients with cancer."
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 Austin, Texas, and San Carlos, California. For more information, visit www.natera.com.
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, coverage and reimbursement determinations from third-party payers, or our expectations or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
References
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer Version 1.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed February 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. Accessed February 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. Accessed January 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250210708213/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, [email protected]
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., [email protected]