CareDx Achieves Significant Milestone Towards CMS Coverage for AlloSure

BRISBANE, Calif., May 04, 2017 -- CareDx, Inc. (NASDAQ:CDNA) announces that Palmetto GBA has released a draft local coverage determination (LCD) for AlloSure. AlloSure is the first and only non-invasive test that uses donor derived cell free DNA as a biomarker to directly measure allograft injury and identify the probability of active rejection.

 

"This marks an important milestone in making AlloSure available to kidney transplant patients," said Peter Maag, Chief Executive Officer at CareDx. "We are tracking against a commercial launch of AlloSure later in 2017 following the completion of reimbursement discussions. The draft LCD release underscores our leadership position in partnering with the transplant community on novel diagnostic solutions to improve patient management and long-term outcomes.”

The draft local coverage decision was issued following completion of the MolDx (Molecular Diagnostics) Technical Assessment process by Palmetto GBA. During the technical assessment process, subject matter experts and the MolDx team determine if an assay demonstrates clinical utility and fulfills the Centers for Medicare & Medicaid Services (CMS) ‘reasonable and necessary’ criteria. In order to receive favorable review results, the assay must also meet analytical and clinical validity standards.

 

CMS has awarded Palmetto GBA with the administration of the Molecular Diagnostics Program. The MolDx group at Palmetto has accumulated a wealth of knowledge on the clinical use of high value diagnostics. Other Medicare Administrative Contractors that participate in the Palmetto GBA MolDX Program are expected to also issue local coverage determinations for AlloSure in the near future.

 

There were over 19,000 kidney transplants in 2016 in the US, but about 20% will experience rejection in the first five years. With a long waiting list to receive a kidney transplant, graft loss is devastating.  “Once kidney disease patients receive a transplant, their quality of life significantly improves,” said Jim Gleason, TRIO National President. “Better diagnostics that support the patient management and rejection detection are needed. The transplant community looks forward to having the AlloSure test available to support those long-term post-transplant life benefits.”

 

The draft LCD can be found online here: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=37265&ContrId=381&ver=6&ContrVer=1&CntrctrSelected=381*1&Cntrctr=381&name=&DocType=AllProposed&s=34%7c48%7c53%7c58&bc=AggAAAQAAAAAAA%3d%3d&

 

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 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.

 

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 about our business, research, development and commercialization efforts including, but not limited to the development, commercialization, utility, performance and adoption of AlloSure. 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 risk associated with successful research, development and planned commercialization of our technologies, 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 14, 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.

 

 

 

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