CareDx Receives Final Medicare Coverage Decision for AlloSure HeartFinal decision on AlloSure Heart paves the way for HeartCare, the most comprehensive multi-modality tool available to heart transplant patients

SOUTH SAN FRANCISCO, Calif., Oct. 01, 2020 (GLOBE NEWSWIRE) -- CareDx, Inc.. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, announced the release of the final local coverage determination by Palmetto MolDx for AlloSure Heart.

AlloSure Heart is a donor-derived cell-free DNA (dd-cfDNA) test which can identify underlying cell injury leading to organ rejection. Medicare reimbursement for AlloSure Heart followed a rigorous technical assessment by the MolDx program and further highlights the value of dd-cfDNA testing for transplant patient management. AlloSure Heart was validated in a multicenter prospective study published in the American Journal of Transplantation. The study data adds to the growing suite of peer reviewed published evidence surrounding the clinical utility of dd-cfDNA in managing patient care.

The final coverage decision also paves the way for HeartCare, the combination of AlloSure Heart and AlloMap Heart, to be made available to providers and patients. The combined use of AlloSure Heart dd-cfDNA and AlloMap Heart gene expression profiling provides a multi-modality and noninvasive solution for managing the care of transplant patients.

“HeartCare has been instrumental in managing our patients. Especially in the COVID pandemic where access to in-person biopsies is more limited, a non-invasive solution for our patients is game-changing for home management of heart transplant recipients,” said Andrew Kao, MD, Saint Luke’s Health System Kansas City Mid America Heart Institute.

“The Medicare coverage determination expands access to our non-invasive solutions, optimizes patient care, and helps fulfill the healthcare team objective of one organ for life,” said Peter Maag, Chief Executive Officer for CareDx.

About CareDx
CareDx, Inc., headquartered in South San Francisco, California, is a leading precision medicine solutions company focused on the discovery, development and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. For more information, please visit:


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