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 congratulates C-Path’s Transplant Therapeutics Consortium and the Paris Transplant Group for their leadership in gaining European Medicine Agency (EMA) draft qualification1 for the iBox® Scoring System as a secondary endpoint in kidney transplant clinical trials.
“CareDx congratulates C-Path’s Transplant Therapeutics Consortium and the Paris Transplant Group for receiving this regulatory approval for the iBox Scoring System. We applaud their pioneering ingenuity in customizing the iBox risk prediction scoring system for this application which is poised to have a significant impact on transplant patient lives,” said Reg Seeto, CEO and President of CareDx. “We are proud to be long-standing collaborators with the incredible teams at the Transplant Therapeutics Consortium and the Paris Transplant Group and look forward to working together to drive the next wave of transplant innovation.”
The iBox Scoring System is a composite biomarker that utilizes multiple clinically relevant patient features to fully reflect the heterogeneity of graft failure, including measures of renal function (eGFR and proteinuria) and immunologic response to the graft (donor-specific antibody), and assessment of allograft health through histopathology (Banff lesion scores).2 For more details, go here.
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 the potential benefits and results that may be achieved with iBox Scoring System, the receipt of EMA draft qualification by C-Path's Transplant Therapeutics Consortium and the Paris Transplant Group (“Receipt of Qualification”), and CareDx’s collaborations with C-Path's Transplant Therapeutics Consortium and the Paris Transplant Group (the “Collaborations”). 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 does not realize the expected benefits of the ibox Scoring System and the Collaborations; risks that C-Path's Transplant Therapeutics Consortium and the Paris Transplant Group do not realize the expected benefits of the iBox Scoring System, the Receipt of Qualification, and the Collaborations; 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, 2021 filed by CareDx with the SEC on February 24, 2022, the quarterly report on Form 10-Q for the quarter ended March 31, 2022 filed by CareDx with the SEC on May 5, 2022, the quarterly report on Form 10-Q for the quarter ended June 30, 2022 filed by CareDx with the SEC on August 4, 2022, 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.
- The draft qualification opinion is going through a public consultation stage through Nov. 17, 2022.
- Accessed online at: https://c-path.org/c-paths-transplant-therapeutics-consortium-receives-acceptance-of-letter-of-intent-for-ibox-scoring-system-composite-biomarker-panel-as-a-reasonably-likely-surrogate-endpoint/. October 18, 2022
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