BRISBANE, Calif., May 27, 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, today announced that the DART study has reached its enrollment goal.
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 kidney transplant recipients. Blood specimens and information on allograft status are serially collected at planned post-transplant surveillance visits and also when allograft rejection is suspected or treated. The study is part of the clinical validation plan for AlloSure™, a proprietary diagnostic test that measures the fraction of donor-derived cell-free DNA (dd-cfDNA) in the blood of transplant patients as a new tool for the non-invasive detection of clinical or sub-clinical rejection.
As of May 26, the DART study enrolled 398 patients with 1,243 study visits at 14 major renal transplant centers across the U.S., with the first patient enrollment in May 2015.
Patients in the DART study undergo multiple scheduled visits as part of their post-transplant care. Data from the DART study will be used as part of a robust dataset in post-transplantation surveillance. Follow up for all DART study patients is planned for two years from transplantation.
“The CareDx Research, Development and Clinical teams are working with a number of outstanding kidney transplant programs in the DART study,” says James Yee, MD PhD, Chief Medical Officer of CareDx. “There’s a great deal of interest in cell-free DNA and next-generation sequencing technologies in the field of transplantation, and we look forward to the execution of the first prospectively planned analyses.”
Dr. Dan Brennan, Director, Transplant Nephrology at the Washington University at St. Louis stated: “We’re extremely excited to be part of this trial. Being able to use this test not just to rule out rejection but for other clinical decisions, such as the adjustment of immunosuppressive therapy, offers great promise to our patients.”
CareDx, Inc., headquartered in Brisbane, California, is a global molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic surveillance solutions for transplant patients. The company markets AlloMap®, a gene expression test that aids clinicians in identifying heart transplant patients with stable graft function who have a low probability of moderate to severe acute cellular rejection. CareDx is pursuing the development of additional products for transplant monitoring using a variety of technologies, including AlloSure™, a proprietary next-generation sequencing–based test to detect donor-derived cell-free DNA after transplantation.
CareDx, with its presence through Olerup AB, 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. Olerup SSP®, a set of HLA typing is used prior to hematopoietic stem cell/bone marrow transplantation and organ transplantation; and XM-ONE®, the first standardized test that quickly identifies a patient’s antigens against HLA Class I, Class II or antibodies against a donor’s endothelium. For more information, please visit: www.CareDx.com.
Forward Looking Statements
In addition to the historical information, this press release contains forward-looking statements with respect 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. These factors, together with those 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, 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.
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