First Patient Enrolled in Landmark CareDx OKRA Registry
CareDx drives best in class 4,000 transplant patient registry with KOAR and OKRA
BRISBANE, Calif., Sept. 18, 2019 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced the enrollment of the first patient in the Outcomes of KidneyCare in Renal Allografts (OKRA) registry from the University of Maryland School of Medicine.
OKRA is a multicenter, prospective, observational registry, designed to measure outcomes of kidney transplant recipients managed with KidneyCare. KidneyCare complements AlloSure to include multimodality testing with the addition of AlloMap Kidney Gene Expression Profiling and prognostic graft assessment using iBox.
“Our team is excited to be the first center to enroll patients. We moved quickly to get OKRA in place at the University of Maryland School of Medicine (UMSOM) so we can begin offering KidneyCare to our transplant patients,” said Dr. Jonathan Bromberg, MD, PhD, Professor of Surgery, Microbiology and Immunology at UMSOM. “The addition of gene expression and graft survival estimates will provide new information to expand our clinical experience,” echoed Dr. Matthew Weir, MD, Director of the Division of Nephrology, and Professor of Medicine at UMSOM.
The patient transplant registry, which will be comprised of 4,000 transplant patients, is statistically powered to determine the utility of KidneyCare and provide real world data on the use of KidneyCare and AlloSure. OKRA targets more than 50 transplant centers and will enroll 1,500 newly transplanted patients, complementing the Kidney Outcomes Allograft Registry (KOAR) with 1,500 patients, matching both arms with 1,000 control patients.
“Data on 4,000 patients provides the ultimate registry to provide clarity on the utility of AlloSure and KidneyCare, and will generate many insights that show promise in improving patient outcomes,” said Sham Dholakia, Senior Vice President of Medical Affairs at CareDx.
About CareDx
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.
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Forward Looking Statements
This press release includes forward-looking statements, including statements regarding the expected size and composition of the OKRA and KOAR registries. 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 numerous risks and uncertainties, including risks related to enrollment in the OKRA and KOAR registries, among others discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2018 filed by CareDx with the SEC on March 6, 2019 and the periodic reports that CareDx has subsequently 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.
CONTACTS:
Sasha King
Chief Marketing Officer, CareDx Inc.
415-287-2393
Michael Bell
Chief Financial Officer, CareDx Inc.
415-287-2324
