BRISBANE, Calif. and NICE, France, April 16, 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 new evidence that the proportion of cell-free DNA (cfDNA) derived from the transplanted organ and found in the bloodstream of the recipient is correlated to the rejection status of the organ. Furthermore, this new biomarker (cfDNA) in combination with AlloMap®, the Company's molecular diagnostic surveillance solution, provides greater accuracy of identification of rejection in heart transplant recipients than either test alone.
The analyses of blood samples from a subset of patients from the multicenter Cardiac Allograft Rejection Gene expression Observational study II (CARGO II) heart transplant observational study represent the first time that researchers have measured both cfDNA and gene expression profiles (AlloMap) in blood samples taken from the same patients. Dr. Maria G. Crespo-Leiro, a cardiologist from Hospital Universitario A Coruna in Spain, presented the results today at the 35th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT) held in Nice, France.
"While we've known that AlloMap can be used to rule out rejection in selected patients, now we have evidence that cfDNA is a promising biomarker to further assess the likelihood of heart-transplant rejection. These two non-invasive blood tests are complementary to one another and promise to further increase our knowledge of the status of a transplant recipient," said Dr. Crespo-Leiro.
Researchers found that the proportion of donor-derived cfDNA in blood was significantly higher (about 1.7 fold higher, P=0.017) in patients who had a biopsy-confirmed rejection compared to blood transplant recipients who did not have rejection at the time of blood sampling. The mean AlloMap score was on average 4 points higher in patients with biopsy-confirmed rejection than AlloMap scores in patients with no rejection (P=0.007).
The clinical performance of a combination of the two tests resulted in a 10 percent increase in overall accuracy compared to the performance of either of the tests alone.
James Yee, MD, PhD, Chief Medical Officer at CareDx said, "The clinical use of AlloMap has continued to grow since its recommendation for non-invasive monitoring of acute heart transplant rejection in the 2010 ISHLT evidence-based guidelines for patient care. The new results presented today are exciting because they show the promise that the management of patients may be further enhanced when information from cfDNA is added to the AlloMap score. cfDNA levels rise as a signal of damage to the cardiac cells whereas the AlloMap score reflects the relative activation of the recipient's immune system: these two signals provide complementary information that is helpful to more accurately estimate the risk of rejection at the time of testing. CareDx is sponsoring an ongoing study, named D-OAR, to further confirm the clinical performance of the cfDNA along with AlloMap."
A replay webcast of the media briefing, "Further Advancements of Cell-Free DNA as an Important Biomarker for Transplant Recipients – CARGO II Study and Beyond" will be available on the Investor section of the CareDx website: www.caredx.com.
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. 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 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.