Broad coverage, inclusive of all previously covered Signatera indications
Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA and precision medicine, today announced that its genome-based Signatera MRD assay is now covered by Medicare under LCD L38779.
This coverage decision applies to Medicare beneficiaries with colorectal cancer, breast cancer, bladder cancer, ovarian cancer, lung cancer, and pan-cancer immunotherapy monitoring, mirroring the pre-existing coverage for Signatera.
The coverage determination was supported by robust evidence on the validity of the genome-based assay, leveraging the extensive body of literature validating Signatera in over 100 published clinical studies.
Earlier this week at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Natera presented a pan-cancer study of 392 patients (over 2,600 samples) using Signatera Genome. The assay was launched recently for both research and clinical use. It leverages Natera's patented and proven multiplex PCR-NGS (mPCR) technology, which allows for deep sequencing of targeted high-quality variants.
"We are pleased to have Medicare coverage now in place for our genome-based Signatera assay, underscoring the clinical utility of our test, as well as its analytical and clinical validity," said Matthew Mega, senior vice president of market access. "This allows Medicare patients broader access to the latest innovations in our MRD product portfolio."
About Signatera
Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.
About Natera
Natera™ is a global leader in cell-free DNA and genetic testing, 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 validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. 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 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, coverage and reimbursement determinations from third-party payers, or our expectations 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/20250604942709/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc., [email protected]
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., [email protected]