Finalized MolDx LCD Includes Expanded Coverage for Natera’s Prospera™ Portfolio

Key Terms

local coverage determination regulatory

A local coverage determination is a region-specific decision by a public health insurer about whether a particular medical test, treatment, or device will be paid for in that area. Think of it like a local rulebook that says which procedures qualify for reimbursement; it matters to investors because such rules directly affect how much revenue health providers, device makers, or diagnostic companies can earn in that market and how widely a product will be adopted.

lcd regulatory

A liquid crystal display (LCD) is a flat-panel screen technology that uses a layer of liquid crystals to control light and form images, like tiny adjustable window blinds that let varying amounts of light through to make pictures. Investors care because LCD production, demand and pricing affect revenue, profit margins and supply chains for electronics makers and retailers, so shifts in LCD costs or adoption can change company earnings and capital needs.

cell-free dna medical

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.

allograft medical

Tissue taken from one person and transplanted into another to repair or replace damaged body parts, such as bone, skin, or heart valves. For investors, allografts matter because their use involves manufacturing standards, supply and safety controls, regulatory approvals, and reimbursement rules that can affect sales, liability and growth for companies that process, store or sell these biological materials — similar to how sourcing and quality control of key parts affect a manufacturer’s business.

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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, 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/20260716661899/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.