NCCN Strengthens Guidance on ctDNA in Colon Cancer, Rectal Cancer, and Merkel Cell Carcinoma
Natera (NASDAQ: NTRA) announced significant updates to the National Comprehensive Cancer Network (NCCN) Guidelines regarding circulating tumor DNA (ctDNA) testing. The NCCN has now included ctDNA as a high risk factor for recurrence in colon and rectal cancer guidelines, marking the first formal recognition of ctDNA's prognostic value.
For Merkel Cell Carcinoma (MCC), the guidelines now positively recommend ctDNA monitoring for surveillance, suggesting tests every 3 months. This recommendation cites Natera's Signatera study data, which showed 95% detection at enrollment and 20x higher recurrence risk in persistently positive patients.
MCC, affecting approximately 3,000 patients annually (mostly elderly), has a 40% recurrence rate within 5 years. The inclusion of ctDNA testing in these guidelines represents a significant step toward more personalized cancer care.
Natera (NASDAQ: NTRA) ha annunciato importanti aggiornamenti alle linee guida del National Comprehensive Cancer Network (NCCN) riguardanti il test del DNA tumorale circolante (ctDNA). L'NCCN ha ora incluso il ctDNA come un fattore ad alto rischio di recidiva nelle linee guida per il cancro al colon e al retto, segnando il primo riconoscimento formale del valore prognostico del ctDNA.
Per il Carcinoma a Cellule di Merkel (MCC), le linee guida raccomandano ora positivamente il monitoraggio del ctDNA per la sorveglianza, suggerendo test ogni 3 mesi. Questa raccomandazione si basa sui dati dello studio Signatera di Natera, che ha mostrato una rilevazione del 95% al momento dell'arruolamento e un rischio di recidiva 20 volte superiore nei pazienti persistente positivi.
Il MCC, che colpisce circa 3.000 pazienti all'anno (principalmente anziani), ha un tasso di recidiva del 40% entro 5 anni. L'inclusione del test del ctDNA in queste linee guida rappresenta un passo significativo verso una cura del cancro più personalizzata.
Natera (NASDAQ: NTRA) anunció actualizaciones significativas en las Guías del National Comprehensive Cancer Network (NCCN) sobre pruebas de ADN tumoral circulante (ctDNA). El NCCN ahora ha incluido el ctDNA como un factor de alto riesgo para la recidiva en las guías del cáncer de colon y recto, marcando el primer reconocimiento formal del valor pronóstico del ctDNA.
Para el Carcinoma de Células de Merkel (MCC), las guías ahora recomiendan positivamente el monitoreo de ctDNA para la vigilancia, sugiriendo pruebas cada 3 meses. Esta recomendación cita los datos del estudio Signatera de Natera, que mostró una detección del 95% en el momento de la inclusión y un riesgo de recidiva 20 veces mayor en pacientes persistentemente positivos.
El MCC, que afecta a aproximadamente 3,000 pacientes anualmente (principalmente ancianos), tiene una tasa de recidiva del 40% en 5 años. La inclusión de pruebas de ctDNA en estas guías representa un paso significativo hacia una atención más personalizada del cáncer.
Natera (NASDAQ: NTRA)는 순환 종양 DNA (ctDNA) 검사와 관련하여 National Comprehensive Cancer Network (NCCN) 지침에 중요한 업데이트를 발표했습니다. NCCN은 이제 ctDNA를 대장 및 직장암 지침에서 재발 고위험 인자로 포함하였으며, 이는 ctDNA의 예측 가치를 공식적으로 인정한 첫 번째 사례입니다.
메르켈 세포 암종 (MCC)의 경우, 지침은 이제 감시를 위한 ctDNA 모니터링을 긍정적으로 권장하며, 3개월마다 테스트를 제안합니다. 이 권장은 Natera의 Signatera 연구 데이터를 인용하며, 연구에서 등록 시 95%의 검출률과 지속적으로 양성인 환자의 경우 20배 높은 재발 위험이 나타났습니다.
MCC는 매년 약 3,000명의 환자 (주로 노인)가 발생하며, 5년 이내에 40%의 재발률을 보입니다. 이러한 지침에 ctDNA 검사 포함은 개인화된 암 치료를 위한 중요한 진전을 나타냅니다.
Natera (NASDAQ: NTRA) a annoncé des mises à jour significatives des lignes directrices du National Comprehensive Cancer Network (NCCN) concernant les tests de l'ADN tumoral circulant (ctDNA). Le NCCN a désormais inclus le ctDNA comme un facteur à haut risque de récidive dans ses lignes directrices sur le cancer du côlon et du rectum, marquant la première reconnaissance officielle de la valeur pronostique du ctDNA.
Pour le Carcinome à Cellules de Merkel (MCC), les lignes directrices recommandent désormais positivement la surveillance du ctDNA, suggérant des tests tous les 3 mois. Cette recommandation se fonde sur les données de l'étude Signatera de Natera, qui ont montré un taux de détection de 95% lors de l'inscription et un risque de récidive 20 fois plus élevé chez les patients positifs persistants.
Le MCC, qui touche environ 3 000 patients par an (principalement des personnes âgées), a un taux de récidive de 40% dans les 5 ans. L'inclusion des tests ctDNA dans ces lignes directrices représente un pas significatif vers des soins oncologiques plus personnalisés.
Natera (NASDAQ: NTRA) hat bedeutende Updates zu den Richtlinien des National Comprehensive Cancer Network (NCCN) bezüglich der Testung von zirkulierender Tumor-DNA (ctDNA) bekannt gegeben. Das NCCN hat nun ctDNA als Hochrisikofaktor für Rückfälle in den Richtlinien für Dickdarm- und Enddarmkrebs aufgenommen, was die erste formelle Anerkennung des prognostischen Wertes von ctDNA darstellt.
Für das Merkelzellkarzinom (MCC) empfehlen die Richtlinien nun positiv das Monitoring von ctDNA zur Überwachung und schlagen Tests alle 3 Monate vor. Diese Empfehlung verweist auf die Studiendaten von Nateras Signatera, die eine Erkennungsrate von 95% bei der Einschreibung und ein 20-fach höheres Rückfallrisiko bei dauerhaft positiven Patienten zeigten.
Das MCC betrifft jährlich etwa 3.000 Patienten (vorwiegend ältere Menschen) und weist eine Rückfallrate von 40% innerhalb von 5 Jahren auf. Die Einbeziehung von ctDNA-Tests in diese Richtlinien stellt einen bedeutenden Schritt in Richtung einer personalisierten Krebsbehandlung dar.
- First-time formal recognition of ctDNA as prognostic marker in NCCN guidelines for colon and rectal cancer
- Positive recommendation for Signatera ctDNA monitoring in MCC surveillance
- Strong clinical data showing 95% detection rate and 20x higher recurrence risk identification
- Guidelines remain cautious about ctDNA for surveillance in colon and rectal cancer
Insights
The NCCN guideline updates represent a significant commercial catalyst for Natera's Signatera test, marking the first formal recognition of ctDNA as a prognostic marker in colorectal cancers. This development carries several important implications:
- The inclusion in NCCN guidelines typically accelerates insurance coverage and reimbursement decisions, potentially expanding Natera's addressable market
- For colorectal cancer, which sees approximately 150,000 new cases annually in the US, the recognition of ctDNA as a high-risk factor could drive substantial test adoption
- While Merkel cell carcinoma is rare (~3,000 cases/year), the strong recommendation for surveillance testing every 3 months creates a recurring revenue stream per patient
- The guideline updates arrived ahead of typical timelines, suggesting strong clinical evidence and growing acceptance of ctDNA technology
The positive recommendation specifically citing Signatera data strengthens Natera's competitive position in the liquid biopsy market. The company's first-mover advantage in getting NCCN recognition for MCC could serve as a blueprint for expanding coverage across other cancer types, potentially accelerating future guideline updates. The timing is particularly strategic, coming shortly after supportive data from the phase III CALGB study was presented at ASCO GI, which could further influence adoption patterns.
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 Journal of Clinical Oncology (JCO). The study demonstrated excellent performance of Signatera, with
“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
“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
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.
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Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Source: Natera, Inc.
FAQ
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