BRISBANE, Calif., May 4, 2015 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value, non-invasive surveillance solutions for transplant recipients, today announced that the Cleveland Clinic has enrolled the first patients into a multicenter observational study designed to demonstrate the clinical performance characteristics of circulating cell-free DNA (cfDNA) in detecting clinical and sub-clinical rejection in kidney allograft recipients. The study is also designed to demonstrate the correlation of circulating cfDNA to renal function, both serum creatinine and estimated glomerular filtration rate.
The Circulating Donor-Derived Cell-Free DNA in blood for diagnosing Acute Rejection in Kidney Transplant Recipients (DART) study is a prospective, multicenter, observational study of de-novo kidney transplant subjects where blood specimens will be drawn periodically after transplant and also after treatment for acute rejection. The first phase of the DART study is expected to enroll 200 patients in at least ten centers over a minimum of 18 months. A second phase of the DART study, to establish clinical utility, is expected to commence after initial results are obtained from the first phase.
"We are delighted to announce that the enrollment process for our DART study has begun," said Dr. Peter Maag, PhD, Chief Executive Officer of CareDx. "We are excited about the potential application of cell-free DNA surveillance solutions to transplant medicine. Improving surveillance and optimizing treatment has the potential to have tremendous impact on transplant patients. Following our acquisition of ImmuMetrix last year and the proof of concept achieved through our CARGO II data in heart, the commencement of this trial marks another milestone for CareDx in our dedication to bringing cell-free DNA technology to transplantation. We are now dedicated to partnering with the leaders in the field to make this solution quickly available for their patient management. "
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 with stable graft function who have a low probability of moderate/severe acute cellular rejection. 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. The Company is currently investigating a research use only donor-derived cell-free DNA-based test for heart transplant recipients. For more information, please visit: www.CareDx.com.
Forward Looking Statements
This press release contains forward-looking statements including, but not limited to statements regarding the Company's expectations regarding future potential, development and commercial activities. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward looking statements, including CareDx's limited operating history and experience with developing new markets; risk relating to new partnerships and commercialization of those relationships, as well as other risks stated in CareDx's filings with the SEC located at www.sec.gov. CareDx disclaims any obligation to publicly update or revise any forward looking statements to reflect events that occur or circumstances that exist after the date on which they were made.