Signatera™ MRD Outperformed AMERK Testing in Predicting Merkel Cell Carcinoma Recurrence in JAMA Dermatology Study

Key Terms

mrd medical

MRD stands for minimal residual disease, the tiny number of cancer cells that can remain in the body after treatment and that may not show up on routine scans. Detecting MRD is like finding a few seeds left in a garden after clearing: it helps doctors predict the chance of relapse and measure how effective a therapy is, which investors watch because MRD results can influence clinical trial success, regulatory decisions, and a drug’s market potential.

hazard ratio medical

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

positive predictive value medical

Positive predictive value is a measure of how likely it is that a positive result actually indicates a true positive. For investors, it helps assess how reliable a signal or indicator is in predicting real opportunities or risks, similar to how knowing that a weather forecast predicts rain accurately helps you decide whether to carry an umbrella. A higher positive predictive value means greater confidence that a positive signal truly reflects a meaningful event.

negative predictive value medical

Negative predictive value is a measure of how reliable a negative result is in confirming that a person or situation is truly free of a problem or condition. For investors, it indicates the likelihood that a negative signal or indicator truly means there is no risk or issue present, helping them assess how much trust to place in avoiding potential problems based on current information.

cell-free dna technical

Fragments of DNA that float freely in the bloodstream after being released by dying or damaged cells, like puzzle pieces carried downstream that hint at what’s happening upstream. Investors care because measuring these fragments enables non‑invasive tests — for example to detect cancer, monitor treatment response, check pregnancy health, or spot organ rejection — so advances, approvals, or reimbursement changes can quickly affect companies that develop the tests and related technologies.

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Signatera outperformed AMERK, the current standard of care for prognosis and recurrence monitoring, across sensitivity, positive and negative predictive value, and lead time to recurrence

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), 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.”

References

1. McEvoy AM, Lachance K, Hippe DS, et al. Recurrence and mortality risk of Merkel cell carcinoma by cancer stage and time from diagnosis. JAMA Dermatol. 2022;158(4):382-389. doi:10.1001/jamadermatol.2021.6096
2. Paulson KG, Lewis CW, Redman MW, et al. Viral oncoprotein antibodies as a marker for recurrence of Merkel cell carcinoma: a prospective validation study. Cancer. 2017;123(8):1464-1474. doi:10.1002/cncr.30475
3. Miller DM, Shalhout SZ, Wright KM, et al. The prognostic value of the Merkel cell polyomavirus serum antibody test: a dual institutional observational study. Cancer. 2024;130(15):2670-2682. doi:10.1002/cncr.35314

About Natera

Natera is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260722520063/en/

Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Source: Natera, Inc.