Natera, Inc. (NASDAQ: NTRA) announced the publication of a study in JAMA Dermatology comparing its Signatera test against the Merkel cell polyomavirus antibody test, known as AMERK, for monitoring recurrence of Merkel cell carcinoma (MCC), a rare skin cancer that recurs in approximately 40% of patients.

The retrospective analysis of a prospective, multicenter study included 169 MCC patients. Key findings showed Signatera demonstrated a sensitivity of 90% compared to 55% for AMERK. Signatera also showed a higher positive predictive value, higher negative predictive value, and a hazard ratio difference of 6.6 (p < 0.001) over AMERK. In patients where both tests detected recurrence, Signatera identified it a median of 5.1 months before clinical confirmation, compared to 2.1 months for AMERK.

AMERK's utility is limited to roughly 50% of MCC patients whose tumors are virus-positive, and its accuracy is reported to diminish after immunotherapy exposure or multiple recurrences. Signatera was evaluated across all MCC patients regardless of viral status.

"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 is already included in National Comprehensive Cancer Network guidelines as a recommendation for MCC surveillance monitoring. The information in this article is based on a press release issued by Natera.