Decision Reinforces CareDx Commitment to Patients by Defending Clinical Data Integrity and Reaffirms that Natera Intentionally Falsely Advertised to the Transplant Community
CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that the United States District Court for the District of Delaware (the “District Court”) decision upheld and reaffirmed the March 2022 jury verdict finding that Natera (Nasdaq: NTRA) violated the Lanham Act by falsely advertising the scientific performance of its Prospera transplant test.
At the conclusion of the March 2022 trial, the jury found that Natera intentionally and recklessly misled the transplant community by deliberately engaging in false advertising in the promotion and marketing of its Prospera kidney transplant rejection assessment test. On July 17, 2023, the District Court upheld the jury’s prior decision on all of the nine counts, and where the jury found that Natera made false advertising claims about its Prospera kidney transplant test and false advertising comparisons to CareDx’s AlloSure® Kidney.
All of the following claims were found to be FALSE ADVERTISING by Natera about its Prospera test:
- FALSE CLAIM: More sensitive and specific
- FALSE CLAIM: Better performance in correctly classifying patients with active rejection
- FALSE CLAIM: Superior data in detection of clinical and subclinical rejection
- FALSE CLAIM: Superior analytical performance
- FALSE CLAIM: 3x fewer rejections missed
- FALSE CLAIM: Lower risk of missing active rejection
- FALSE CLAIM: Stronger test performance with unique capabilities
- FALSE CLAIM: Unparalleled precision
- FALSE CLAIM: Highly sensitive across a range of rejection types and patients
For the full verdict form with the complete false advertising claims, go here:
In March 2022, a jury found that Natera intentionally and recklessly misled the transplant community by deliberately engaging in false advertising in the promotion and marketing of its Prospera kidney transplant rejection assessment test. Overwhelming evidence emerged at trial that demonstrated that Natera made false statements that its senior executives knew were based on unscientific, unreliable, and inappropriate conclusions to market Prospera. While the District Court did not uphold the monetary damages awarded by the jury, which CareDx intends to appeal, the District Court reaffirmed that Natera falsely advertised its Prospera test to the transplant community.
CareDx is proud to be 100 percent committed to transplant patients and to being a leader in transplant innovation. CareDx was the first to bring donor-derived cell-free DNA (dd-cfDNA), as in AlloSure to kidney, heart, and lung transplant patients, and was also the first to gain MolDX coverage, most recently for AlloSure Lung. CareDx is also proud to be the first to have brought gene expression profiling, as in AlloMap® to heart transplant patients. CareDx’s commitment to scientific data and innovation is driven by its mission to improve outcomes across the entire transplant patient journey.
About CareDx – The Transplant Company
CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey; and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com.
Forward Looking Statements
This press release includes forward-looking statements related to CareDx, Inc., including statements regarding CareDx’s false advertising claim against Natera and the company’s plan to appeal the district court decision to dismiss the jury’s monetary damages award (the “Appeal”). 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 risks that CareDx fails to carry on the Appeal as planned or fails to achieve desirable results in the Appeal; general economic and market factors; and other risks discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed by CareDx with the SEC on February 27, 2023, the quarterly report on Form 10-Q for the quarter ended March 31, 2023 filed by CareDx with the SEC on May 10, 2023, 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. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.