BRISBANE, Calif., Jan. 7, 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 it received positive coverage decisions from two Medicare Administrative Carrier (MAC) jurisdictions for AlloMap, the Company's molecular diagnostic surveillance solution for heart transplant patients. Jurisdiction 15, administered by Cigna Government Services (CGS) and Jurisdiction F, administered by Noridian, raises coverage of AlloMap to four of the 12 MAC jurisdictions, expanding coverage to states such as Oregon, Washington, Utah, Arizona, Ohio and Kentucky. CareDx has had a positive coverage decision by its local MAC, also Noridian, covering AlloMaps processed at its CLIA Lab since 2006.
While AlloMap has been covered by Medicare since 2006 and cleared by the Food and Drug Administration (FDA) since 2008, the expanded coverage in these two jurisdictions means that Medicare patients in the affected states will no longer need to have their blood drawn for AlloMap testing at a secondary location and can instead be drawn onsite at their clinic of choice, where other laboratory tests are drawn.
"The decision by these two jurisdictions provides greater patient convenience for heart transplant patients using AlloMap," said Peter Maag, President and CEO. "As part of our strategic objective to make AlloMap easily available to heart transplant patients, the additional positive coverage from CGS and Noridian enables Medicare patients in these additional jurisdictions more flexibility when seeking the benefits of this novel, non-invasive diagnostic test." Non-Medicare patients already enjoy the convenience and benefits that these Medicare decisions bring to Medicare subscribers in these jurisdictions, which now covers 11 additional states (Oregon, Washington, Utah, Arizona, Idaho, Montana, North Dakota, South Dakota, Wyoming, Ohio and Kentucky).
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. For more information, please visit: www.CareDxInc.com.
CONTACT: Company Contact: Bradley P. Sherrill Senior Director, Marketing bsherrill@CareDxInc.com 415-287-2397