Medicare Expands Coverage for Signatera™ MRD Test in Hepatocellular Carcinoma

A real-world study of 125 patients supported the Medicare coverage decision.

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Supports serial testing in the surveillance setting for patients with early-stage HCC

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that its Signatera molecular residual disease (MRD) test has received Medicare coverage through the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX) in hepatocellular carcinoma (HCC). The coverage includes serial Signatera testing in the surveillance setting for patients with early-stage HCC who have no post-surgical evidence of disease.

More than 42,000 new cases of liver cancer are expected in the U.S. in 2026¹ and HCC accounts for approximately 90% of primary liver cancers.² Even after curative-intent treatment (e.g., surgery), patients face a high risk of recurrence that makes post-treatment monitoring critical.²

This Medicare coverage decision was supported by a real-world study of 125 patients with HCC published in JCO Precision Oncology. In the study, Signatera outperformed the standard of care and guideline-recommended biomarker, alpha-fetoprotein (AFP), with sensitivity of 83% vs. 42% for AFP, and specificity of 100%. Signatera had a lead time of up to 16.5 months ahead of imaging (median of 7.9 months) vs. 2.2 months for AFP.

“Conventional surveillance tools can miss early signs of relapse in HCC,” said Maen A. Abdelrahim, MD, PhD, Chief of GI Medical Oncology, Houston Methodist Cancer Center, and author of the supporting study. “Imaging after liver surgery or transplant is often hard to interpret, and AFP misses many recurrences. Signatera gave us a signal months earlier, and in our study, it helped clarify ambiguous scans.”

“We’re proud that Medicare coverage has been extended to patients with hepatocellular carcinoma, the most common form of liver cancer,” said Adham Jurdi, MD, Senior Medical Director, GI and Innovations, Medical Affairs, Oncology, Natera. “This milestone gives patients and their physicians greater access to an ultrasensitive, personalized tool to monitor for recurrence.”

References

1. American Cancer Society. Cancer Facts & Figures 2026. Atlanta: American Cancer Society; 2026.
2. Abdelrahim M, Mejia A, Esmail A, et al. Feasibility of Personalized and Tumor-Informed Circulating Tumor DNA Assay for Early Recurrence Detection in Patients With Hepatocellular Carcinoma. JCO Precision Oncology. 2025;9:e2400934. doi:10.1200/PO-24-00934.

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 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 efforts to develop and commercialize new product offerings, 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/20261103680461/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.

Key Terms

molecular residual disease medical

Molecular residual disease is the tiny amount of cancer that can remain in the body after treatment and is detectable only by sensitive tests that find cancer DNA or other molecular traces. It matters to investors because these measurements can predict relapse, guide whether additional therapy is needed, and shape the market for diagnostics and drugs—much like finding embers after a fire helps decide if more firefighting is required.

alpha-fetoprotein medical

A protein normally produced by a developing fetus and by the fetal liver, alpha-fetoprotein (AFP) circulates in blood and is measured as a biomarker. In adults, clinicians and clinical trials use AFP levels—measured from a blood sample—to help detect or monitor certain liver diseases and liver cancers (especially hepatocellular carcinoma) and to interpret some prenatal screening results; elevations are not specific and can occur for other liver injuries, noncancerous conditions, or during pregnancy.

specificity medical

Specificity measures how well a diagnostic test or screening correctly identifies people who do not have a condition — the percentage of healthy cases the test labels as negative. Think of it as a smoke alarm that stays quiet when there’s no fire; high specificity means fewer false alarms. For investors, specificity affects regulatory approval, clinical adoption, follow-up costs, and the perceived reliability and market potential of medical products.