BRISBANE, Calif., Nov. 16, 2016 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients, announced it will attend and leading clinical investigators will present data on AlloSure at the American Society of Nephrology Meeting in Chicago, IL.
AlloSure is a clinical-grade proprietary Next-Generation Sequencing (NGS) based test to detect donor-derived cell-free DNA (dd-cfDNA) in solid organ transplant recipients. The DART study — Circulating Donor-Derived Cell-Free DNA in blood for diagnosing Acute Rejection in Kidney Transplant Recipients — is a study with 14 transplant centers across the United States. This study started in 2015 and has over 400 participants who contributed over 1,200 samples. The objectives of the first study analyses were to validate that AlloSure dd-cfDNA performance to discriminate renal biopsy confirmed active rejection and to define the reference range for AlloSure in routine post-transplant testing.
“Presenting DART’s AlloSure data during Kidney Week is a major milestone for CareDx and its clinical research collaborators. Building on our expertise in transplantation, the company’s newest product has the potential to revolutionize how clinicians care for kidney transplant patients. The negative and positive predictive value of this non-invasive biomarker have exceeded our expectations,” said James Yee, MD, PhD, Chief Medical Officer, CareDx, Inc.
“The DART multicenter study is the largest investigation of cell free DNA ever performed in kidney transplantation. AlloSure shows great promise as a novel biomarker of rejection and related allograft injury unlike serum creatinine which is an indicator of renal function,” said Roy D. Bloom, MD, medical director of renal and pancreas transplantation at University of Pennsylvania.
In addition to the DART data, CareDx will be exhibiting for the first time at this meeting and are involved in two other key events:
CareDx, Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value, non-invasive diagnostic surveillance solutions for transplant recipients. The Company has commercialized AlloMap®, a gene expression test that aids clinicians in identifying heart transplant recipients. CareDx is also pursuing the development of additional products for post-transplant monitoring of other solid organs that use a variety of technologies, including next generation sequencing, to detect donor-derived cell-free DNA to monitor the health of organs after transplantation. For more information, please visit: www.CareDx.com.
CareDx, with its presence through Olerup, also develops, manufactures, markets and sells high quality products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs.
For more information, please visit: www.CareDx.com.
Forward Looking Statements
This press release contains forward-looking statements including, but not limited to our business, research, development and commercialization efforts and anticipated future financial results. These forward-looking statements are based upon information that is currently available to us and our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including the continued successful development and planned commercialization of AlloSure, that are described in our filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2015 filed by us with the SEC on March 29, 2016 and the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2016 filed by us with the SEC on August 22, 2016. Any of these may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.
Last updated on: 17/11/2016
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