Full Press Release Details
Surveillance coverage significantly strengthened with new LCD across kidney, heart, and lung transplantation, expanding coverage for Prospera testing across critical post-transplant settings
AUSTIN, Texas–(BUSINESS WIRE)–Natera, Inc.(NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today highlighted the impact of a final local coverage determination (LCD) for molecular testing for solid organ allograft rejection: L40060.
The LCD strengthens coverage for Prospera in the surveillance settings. The new policy, which is expected to take effect on August 30, 2026, specifically includes:
• Kidney: 6 tests in year 1; 4 per year in years 2-3. “For-cause” coverage remains unchanged.
• Heart:12 tests in year 1; 4 per year in years 2-3. “For-cause” coverage remains unchanged.
• Lung:12 tests in year 1; 4 per year in years 2-3 for both bilateral and single lung transplantation.
The final LCD improves upon the July 2025 draft, which had suggested only 2 tests per year in years 2-3 across all indications; and only 4 tests in year 1 for kidney. Following the release of that draft in July 2025, major medical societies submitted comments to MolDx in support of coverage with expanded test frequency. These included letters from the American Society of Transplant Surgeons (ASTS), the American Society of Transplantation (AST), and the International Society of Heart & Lung Transplantation (ISHLT).
“The finalized LCD expands access to Prospera across critical post-transplant management settings,” said Matt Mega, senior vice president of market access at Natera. “This new policy provides strong support for molecular testing in surveillance, thereby enabling clinicians to respond to rejection and help prevent irreversible damage to donor organs.”
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, visitwww.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 atwww.natera.com/investorsandwww.sec.gov.
Investor Relations: Mike Brophy, CFO, Natera, Inc.,investor@natera.comMedia: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc.,pr@natera.com
Source: Natera, Inc.