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BRISBANE, Calif., Nov. 21, 2016 -- 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, announced today that the Centers for Medicare & Medicaid Services (CMS) issued final changes to the CY 2017 Medicare Clinical Laboratory Fee Schedule (CLFS). These fee changes included AlloMap, which reverted from a proposed rate of $1,920 back to the current reimbursement rate of $2,821. CMS mentioned that changes were based on public input on the preliminary determinations and final 2016 gapfill files issued on September 30, 2016.
“We applaud CMS’s decision to step in and reverse the proposed reduction in reimbursement for AlloMap,” stated Peter Maag, President and CEO of CareDx. “This decision ensures that heart transplant patients and physicians will continue to benefit from the only non-invasive surveillance solution on the market. It is also consistent with the Precision Medicine Initiative that supports medical innovation and improving medical care.”
In 2015, CMS also reversed a proposal to dramatically reduce the reimbursement rate and maintained AlloMap at its historical price of $2,821.
CareDx, based in Brisbane, California, developed AlloMap, invested in the generation of high quality clinical evidence, and has been offering the assay since 2005 with FDA IVD 510K clearance in 2008. The AlloMap testing service was incorporated into the International Society of Heart and Lung Transplantation guidelines in 2010. AlloMap is used in the vast majority of heart transplant centers nationwide, with more than 75,000 commercial tests performed to date.
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. 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.
CareDx, with its presence through Olerup, 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.
For more information, please visit: www.CareDx.com.
Forward Looking Statements
This press release contains forward-looking statements including, but not limited 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, including the continued successful development and planned commercialization of AlloSure, 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 and the Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2016 filed by us with the SEC on November 15, 2016. Any of these 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.
Investor Relations Contact Jamar Ismail, Vice President Westwicke Partners, LLC T: +1 415-513-1282 E: [email protected]
