Natera, Inc. (NASDAQ: NTRA), a leader in cell-free DNA testing, has announced a new study in the Journal of Clinical Oncology showcasing the effectiveness of its personalized molecular residual disease (MRD) test, Signatera, for monitoring Merkel cell carcinoma (MCC). The full study is available here.
Merkel cell carcinoma is a highly aggressive skin cancer with a 40% recurrence rate within five years. While the National Comprehensive Cancer Network (NCCN) recommends MRD testing using a viral antibody, this marker is present in only 52% of patients and has several limitations. There is a clear need for MRD testing methods that work for all patients, regardless of viral status.
This prospective, multicenter study involved 319 patients with stage I-IV MCC. Signatera assessed circulating tumor DNA (ctDNA) levels at enrollment and every three months during the surveillance period. Key findings include:
- Signatera demonstrated approximately 95% sensitivity for detecting clinically evident disease at enrollment.
- Positive ctDNA during surveillance was linked to up to a 20-fold higher risk of recurrence compared to persistently ctDNA-negative patients.
- At 12 months, patients with a positive ctDNA result had a recurrence-free probability of just 9%, while those who remained ctDNA-negative had a 91% probability.
Lisa Zaba, M.D., Ph.D., associate professor of dermatology at Stanford Cancer Center, noted, “Our study indicates that a tumor-informed MRD test can provide valuable prognosis and guidance for MCC surveillance, regardless of viral status.”
Angel Rodriguez, M.D., senior medical director at Natera and co-author of the study, added, “We are encouraged by Signatera’s performance, which demonstrates high prognostic accuracy. This MRD test could become a standard tool for monitoring MCC, helping clinicians make more informed decisions about adjuvant therapy and the need for frequent imaging.”
About Signatera
Signatera is a personalized, tumor-informed MRD test designed for cancer patients. It uses circulating tumor DNA to detect residual cancer, identify recurrences earlier, and guide treatment decisions. The test is available for clinical and research use and is covered by Medicare for several cancer types. It has been validated across multiple cancers with over 70 peer-reviewed publications supporting its effectiveness.
About Natera
Natera™ is a global leader in cell-free DNA and genetic testing, focusing on oncology, women’s health, and organ health. Natera aims to integrate personalized genetic testing into standard care to enable earlier and more targeted interventions. The company’s tests are supported by over 200 peer-reviewed publications and are conducted in ISO 13485-certified and CAP-accredited labs in Austin, Texas, and San Carlos, California.
