AlloSure Heart Clinical Validation Published in Leading Transplant Journal
BRISBANE, Calif., March 11, 2019 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA), a leading molecular diagnostics company focused on the discovery, development, and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients, today announced that clinical validation of AlloSure use in heart transplant patients will be published in the Americal Journal of Transplantation.
CareDx continues it’s 20 year dedication to transplant evidence development with the publication of “Non-invasive Detection of Graft Injury after Heart Transplantation Using Donor-Derived Cell-Free DNA: a Prospective Multi-Center Study” in the American Journal of Transplantation (AJT). This study is the first large, prospective, multicenter clinical validation to show the ability of AlloSure Heart donor derived cell-free DNA test to detect acute cell-mediated and antibody-mediated acute rejection in heart transplant recipients.
The validation of AlloSure Heart to complement AlloMap is of great clinical importance, as the two tests together render a higher precision assessment of the heart allograft than either test alone. CareDx is providing HeartCare, which includes AlloMap and AlloSure Heart, through the Surveillance HeartCare Outcomes Registry (SHORE). SHORE will engage more than 35 centers and 2000 patients, and currently 6 centers are initiated and 50 patients enrolled. The first patient was enrolled at Baylor Scott & White in Dallas, Texas in December 2018.
Kiran Khush, Associate Professor of Medicine at Stanford University, is the lead author on the AJT publication and the principal investigator for SHORE at Stanford. She was an instrumental pioneer in generating evidence supporting the use of dd-cfDNA for acute rejection monitoring. “HeartCare will provide valuable insights for the clinical care of our heart transplant recipients,” said Kiran Khush. “I applaud CareDx for their dedication to innovation in transplantation.”
“Standardization of surveillance use of HeartCare at heart transplant centers through SHORE will provide a powerful database to enable new understanding of how to imporve long term patient outcomes.” said Jim Yee, Chief Medical Officer at CareDx.
About CareDx CareDx, Inc., headquartered in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant recipients. CareDx offers products along the pre- and post-transplant testing continuum, 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, including statements regarding the Company’s publication in American Journal of Transplantation. 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 general economic and market factors, 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, 2017 filed by CareDx with the SEC on March 22, 2018 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.
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