AUSTIN, Texas, July 22, 2026
Natera announced the publication of a prospective, multicenter study in JAMA Dermatology demonstrating that its Signatera™ molecular residual disease (MRD) test significantly outperformed the Merkel cell polyomavirus antibody (AMERK) test for monitoring recurrence in patients with Merkel cell carcinoma (MCC). The study showed that Signatera delivered superior sensitivity, predictive accuracy, and earlier detection of disease relapse compared with the current standard surveillance method. Unlike AMERK, which is limited to virus-positive tumors, Signatera demonstrated consistent performance across both virus-positive and virus-negative MCC patients, supporting its role as a universal biomarker for recurrence monitoring.
Head-to-Head Study Demonstrates Superior Recurrence Prediction
The retrospective analysis evaluated prospectively collected data from 169 patients with Merkel cell carcinoma, directly comparing Signatera with AMERK testing. Signatera proved to be a significantly stronger predictor of disease recurrence, demonstrating a higher hazard ratio, improved positive predictive value (PPV), and higher negative predictive value (NPV). The assay detected 90% of recurrences, substantially outperforming AMERK, which achieved 55% sensitivity. Researchers also reported that Signatera identified recurrence significantly earlier, with a median lead time of 5.1 months, compared with 2.1 months for AMERK among patients whose recurrence was detected by both tests.
Universal MRD Monitoring Expands Surveillance Across All MCC Patients
Merkel cell carcinoma is a rare but highly aggressive skin cancer with recurrence rates approaching 40%. While AMERK has served as a surveillance tool for virus-positive disease, its clinical utility is restricted because approximately half of MCC patients have virus-negative tumors, and test performance declines following immunotherapy or repeated recurrences. Signatera overcomes these limitations by using personalized circulating tumor DNA (ctDNA) analysis that is independent of viral status. The technology has already been incorporated into NCCN Guidelines as a recommended surveillance option for Merkel cell carcinoma patients.
Advertisement
Publication Strengthens Clinical Evidence for Personalized Cancer Monitoring
Investigators concluded that Signatera provides clinicians with a more reliable and earlier indication of relapse, enabling more proactive patient management following treatment. Company leaders noted that the study reinforces Signatera’s position as a precision oncology biomarker capable of improving surveillance across a broader patient population than existing antibody-based monitoring approaches. Natera continues expanding clinical validation of its cell-free DNA technologies across oncology, women’s health, and organ health, with more than 400 peer-reviewed publications supporting its precision medicine platform.
Source: Natera press release
