TAMPA, Fla., July 13, 2016 /PRNewswire/ -- CareDx, Inc. (NASDAQ: CDNA), a molecular diagnostics company, today called for Medicare Administrative Contractor First Coast Service Options, Inc. to reverse its recent proposal to drastically reduce reimbursement for its FDA-cleared diagnostic test AlloMap, which measures gene expression levels to help clinicians determine a heart transplant recipient's risk for organ rejection.
Allomap enables physicians to order a blood test instead of an invasive biopsy.
"Not only does First Coast refuse to disclose the basis for its harmful proposed rate cut, it refuses to even meet with us to learn why it is mistaken," said Peter Maag, President and CEO of CareDx. "If First Coast's proposal is adopted, we won't be able to offer AlloMap to Medicare patients anymore because the proposed rate is less than our cost."
Mr. Maag spoke today at a telephonic press conference along with Florida heart transplant recipient Kenneth Mitchell and leading Florida cardiologist Debbie Hoffman, who talked of the importance of AlloMap and called on First Coast to reverse its proposal.
"AlloMap provides a significant advantage in post-transplant care," said Dr. Hoffman. "It would be an outrage if we could not offer it to our Medicare patients."
"I don't understand why anyone would cause AlloMap to be taken from a patient who has been through so much," added Mr. Mitchell. "AlloMap makes my life better."
CareDx, based in Brisbane, California, developed AlloMap and has been distributing the test since 2005. AlloMap is used in 111 of the 129 heart transplant centers nationwide. AlloMap's unique surveillance system allows patients to avoid many invasive biopsies. Results are reported to health care providers less than 48 hours after the test is administered, which is a critical time when assessing the risk of organ rejection. AlloMap is often referenced as one of the first examples of precision or personalized medicine already put into widespread clinical practice.
About CareDx
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. 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 the effect of possible CMS decisions on the Company's financial results and commercial operations. Forward looking statements are subject to uncertainties that could cause actual performance or results to differ materially from those expressed in the forward looking statements, including the Company's ability to enter new businesses or other geographies if it is forced to discontinue AlloMap testing in the United States. 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.