BRISBANE, Calif., July 28, 2014 (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 the results of its cohort studies of blood samples from the multicenter CARGO and CARGO II heart transplant observational studies, and from the KARGO kidney transplant study during a presentation today at The World Transplant Congress in San Francisco, CA.
In his oral abstract, Dr. Robert Woodward, Ph.D. and co-authors from CareDx demonstrated that graft-derived cfDNA proportion in heart transplant and kidney transplant recipient's blood is significantly higher in patients who had a biopsy-confirmed rejection compared to that found in transplant recipients who did not have any evidence of rejection at the time of blood sampling. There was a 10-fold median cfDNA proportion increase in the CARGO and 5-fold in the CARGO II heart recipients with biopsy-proven rejection in comparison to the cfDNA levels from patients without rejection. In kidney transplant recipients, the median graft-derived cfDNA was 3-fold higher in the KARGO patients with biopsy-proven rejection in comparison to the cfDNA levels in blood from kidney recipients without rejection.
"These results represent just the tip of the iceberg of data we expect to emanate from existing CareDx repositories of blood samples and clinical data that will accelerate our understanding and development of graft-derived, cell-free DNA test solutions for managing the care of kidney as well as with AlloMap® for heart transplant recipients," said James Yee, MD, Chief Medical Officer. "CareDx is also starting new, prospective studies applying this promising new molecular biomarker to transplant recipients."
The World Transplant Congress is the second joint meeting of the American Society of Transplant Surgeons (ASTS), The Transplantation Society (TTS) and the American Society of Transplantation (AST). The event brings together the largest group of transplant scientists, physicians, surgeons, trainees, nurses, organ procurement personnel, pharmacists and other associated transplant professionals from around the world.
AlloMap Molecular Testing is intended to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (ACR) at the time of testing in conjunction with standard clinical assessment. AlloMap is performed in the CLIA-certified and CAP-accredited clinical laboratory at CareDx and has been commercially available in the United States since 2005. AlloMap was cleared by the U.S. Food and Drug Administration in 2008 and was CE marked for the European Union in 2011. Recommended use of AlloMap for heart transplant rejection surveillance is included in the International Society for Heart and Lung Transplantation (ISHLT) Guidelines for the care of heart transplant recipients, published in August, 2010: "Gene Expression Profiling (Allomap) can be used to rule out the presence of ACR of grade 2R or greater in appropriate low-risk patients, between 6 months and 5 years after HT." These guidelines represent the worldwide standard for the care of heart transplant patients.
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.
For more information, please visit: www.CareDxInc.com.
CONTACT: CareDx, Inc. Bradley P. Sherrill Senior Director, Marketing Tel: 415-287-2397 bsherrill@CareDxInc.com