Natera comments on updated NCCN guidance for circulating tumor DNA

Natera (NTRA) commented on recent updates by the NCCN on circulating tumor DNA molecular residual disease testing in the Clinical Practice Guidelines in Oncology for colon cancer, rectal cancer, and merkel cell carcinoma. In its updated guidelines for colon cancer and for rectal cancer, 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 / 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.” 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. 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.