CareDx Announces Finalization of Solid Organ Transplant Molecular Testing Local Coverage Determination

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.

molecular testing medical

Molecular testing analyzes tiny biological markers—like DNA, RNA or specific proteins—to detect diseases, identify pathogens or measure treatment-related changes. Think of it as reading a biological barcode or fingerprint that tells doctors exactly what is happening at the cellular level. For investors, molecular tests matter because they drive demand for diagnostic products, influence clinical trial outcomes and regulatory decisions, and can quickly change revenue and valuation when adopted in clinical care.

allograft rejection medical

Allograft rejection is the immune system’s attack on a transplanted tissue or organ from another person, where the recipient’s defenses recognize the graft as foreign and try to destroy it. Investors should care because rejection affects the success of transplant procedures and related therapies, drives demand for immunosuppressive drugs and diagnostics, and is a key clinical or regulatory endpoint that can determine a product’s market potential—think of it as a security team mistakenly ejecting an invited guest, undermining the event.

for-cause testing medical

Testing performed because there is a specific, documented reason or suspicion—such as an accident, observed impairment, complaint, violation, or safety concern—rather than as part of routine or random screening. Like pulling a car into the shop after the warning light comes on, for-cause testing targets individuals or situations where there is cause to believe a problem exists. For investors, it signals targeted compliance action that can affect legal exposure, operational continuity, and potential costs.

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Coverage for Surveillance Testing Affirmed for Early Detection of Allograft Rejection in Kidney, Heart, and Lung

BRISBANE, Calif.--(BUSINESS WIRE)-- CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine diagnostics company in transplant, specialty oncology, and cell therapy, today announced the finalization of the Medicare Local Coverage Determination (LCD) process related to molecular testing for solid organ allograft rejection. The final policy affirms coverage across CareDx’s transplant surveillance offerings in kidney, heart, and lung.

Kidney: The policy affirms coverage of AlloSure® Kidney for surveillance testing for up to six tests in the first-year post-transplant and for up to four tests per year in years two and three. Coverage of for-cause testing is unchanged and available when clinically indicated. AlloSure Kidney patients currently receive an average of approximately three to four tests in the first year following transplant.

Heart: Coverage is maintained for AlloMap® and AlloSure® Heart, including use of the two tests in combination when medically appropriate. The policy covers up to 12 surveillance tests in the first-year post‑transplant and four tests in years two and three. Coverage of for-cause testing is unchanged and available when clinically indicated.

Lung: Coverage is maintained for AlloSure® Lung for surveillance testing, including up to 12 tests in the first-year post‑transplant and four tests in years two and three. These coverage criteria are consistent with the clinical need for frequent monitoring in the early post-transplant period for lung transplant patients.

"The final policy reinforces the role of molecular surveillance in transplant patient management, providing important clarity for patients and clinicians,” said Dr. Jeffrey Teuteberg, Chief Medical Officer of CareDx. “Our molecular testing services are integral to the clinical management of patients who have undergone kidney, heart, and lung transplants.”

A proposed draft LCD was initially released on July 17, 2025, and was opened for public comment through August 31, 2025. CareDx submitted a comment letter addressing key aspects of the draft. The Final LCD was published on July 16, 2026, and is expected to take effect on August 30, 2026. The policy is available here: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=40060&ver=6.

About CareDx

CareDx is a leading precision medicine diagnostics company advancing care in transplant, specialty oncology, and cell therapy. Through non-invasive longitudinal molecular biomarker testing, digital health, and patient support solutions, CareDx is dedicated to improving patient outcomes. For more information, please visit www.caredx.com.

Forward Looking Statements

This press release includes forward-looking statements related to CareDx including statements regarding the potential benefits and results that may be achieved with AlloSure and AlloMap. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including general economic and market factors, and other risks discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed by CareDx with the SEC on February 25, 2026, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260716462755/en/

CareDx, Inc.
Media
Natasha Moshirian Wagner
nwagner@CareDx.com

Investor Relations
Caroline Corner
investor@CareDx.com

Source: CareDx, Inc.