CareDx Receives Final Medicare Coverage Decision for AlloSure Heart
CareDx, Inc. (Nasdaq: CDNA) announced the release of a final local coverage determination by Palmetto MolDx for AlloSure Heart, a dd-cfDNA test identifying cell injury that leads to organ rejection. Medicare reimbursement for this test follows a thorough technical assessment, highlighting its clinical utility in transplant management. This decision facilitates the launch of HeartCare, which combines AlloSure Heart with AlloMap Heart, offering a comprehensive, non-invasive solution for heart transplant patients during the COVID pandemic. This coverage enhances patient access and optimizes care management.
- Final Medicare coverage determination for AlloSure Heart enhances access for heart transplant patients.
- Launch of HeartCare combines AlloSure Heart and AlloMap Heart, providing a comprehensive testing solution.
- Non-invasive testing options increase patient management efficiencies during the COVID pandemic.
- Peer-reviewed studies support the clinical utility of dd-cfDNA testing.
- None.
Final 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: www.CareDx.com.
CONTACTS:
CareDx, Inc.
Sasha King
Chief Marketing Officer
415-287-2393
sking@caredx.com
Investor Relations
Greg Chodaczek
347-620-7010
investor@caredx.com
