Natera, Inc, a global leader in cell-free DNA and precision medicine, today announced the publication of results from a prospective, multicenter study in Merkel cell carcinoma (MCC) published in JAMA Dermatology. The study evaluated the Signatera test against the Merkel cell polyomavirus antibody test (AMERK), finding Signatera to be a significantly stronger predictor of recurrence that also detected relapse earlier.
MCC is a rare but aggressive skin cancer that recurs in approximately 40% of patients.1 Despite its severity, clinicians have lacked a reliable, universal biomarker to guide surveillance. The AMERK test has been a widely used monitoring tool, but its utility is limited: it can only be used in the roughly 50% of MCC patients whose tumors are virus-positive, and its accuracy diminishes after immunotherapy exposure or multiple recurrences.2-3 Signatera’s clinical validation has been published across all MCC patients, irrespective of viral status, leading to inclusion in NCCN Guidelines as a recommendation for surveillance monitoring.
This published study is a retrospective analysis of a prospective, multicenter, head-to-head comparison of Signatera and AMERK testing in 169 patients with MCC. Key findings include:
- Superior predictive power: The Signatera test was a significantly stronger predictor of recurrence than AMERK (HR difference = 6.6; p < 0.001), with higher hazard ratios, higher positive predictive value (PPV), and higher negative predictive value (NPV).
- Higher Sensitivity: Signatera detected recurrence more frequently than AMERK with a sensitivity of 90% vs 55%, respectively.
- Longer Lead Time: In patients where recurrence was detected by both tests, Signatera detected recurrence earlier than AMERK with a median lead time of 5.1 months vs. 2.1 months, respectively.
“For years, AMERK had been our best available tool, but its inability to function in virus-negative patients and after immunotherapy has been a recognized limitation,” said Lisa Zaba, M.D., Ph.D., associate professor of dermatology and director of the Merkel cell carcinoma multidisciplinary clinic at the Stanford University School of Medicine, and corresponding author of the study. “These data demonstrate that Signatera can give clinicians a more precise and earlier signal across all patients, enabling more proactive management of this challenging disease.”
“Signatera MRD testing outperformed AMERK across every key measure in this study — sensitivity, hazard ratios, predictive values, and lead time to detection,” said Alexey Aleshin, M.D., MBA, corporate chief medical officer and general manager, oncology, at Natera. “Signatera was shown to be a more universally reliable biomarker for MCC surveillance, particularly because it retains its accuracy in both virus-positive and virus-negative disease and after exposure to immunotherapy.”
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