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Palmetto MolDx Issues Foundational Coverage for Molecular Testing in Solid Organ Allograft Rejection

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CareDx, Inc. (Nasdaq: CDNA) has announced that Medicare coverage for its transplant testing services remains unchanged under a new universal coverage policy by Palmetto MolDx. The policy reaffirms patient access to services essential for managing organ transplant care. CareDx’s AlloMap and AlloSure tests, which are critical for identifying organ rejection, have been validated through rigorous studies. This continued coverage supports CareDx's mission in enhancing patient care and solidifies its role as a leader in precision medicine.

Positive
  • Medicare coverage for CareDx's services remains unchanged, ensuring continued access for patients.
  • The policy supports faster coverage for other solid organs in transplantation.
  • AlloMap and AlloSure tests are validated through multicenter studies, reinforcing their clinical utility.
Negative
  • None.

Current Medicare coverage for CareDx services remains unchanged under the new universal coverage policy

SOUTH SAN FRANCISCO, Calif., April 22, 2021 (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 today that Palmetto MolDx finalized the local coverage determination “Molecular Testing for Solid Organ Allograft Rejection,” reaffirming coverage and patient access to transplant testing services.

Medicare coverage for CareDx services remains unchanged under the new foundational coverage policy. This policy provides greater access to care and establishes a faster path to coverage of other solid organs in transplantation.

“We applaud Palmetto MolDx in this policy to support the field of transplant,” said Reg Seeto, President and CEO of CareDx. “This aligns with our mission for patient care and we are so ‘transplant proud’ to have been the first to have brought both gene expression profiling with AlloMap® and dd-cfDNA with AlloSure® to the transplant field.”

AlloMap Heart is the only FDA cleared gene expression profiling test in transplant and is widely adopted by physician providers in over 90% of heart transplant centers across the U.S. The test has been the standard of care and included in guidelines for the International Society for Heart and Lung Transplantation (ISHLT) since 2010. HeartCare is a validated multimodality use of AlloMap Heart with AlloSure Heart.

AlloSure Kidney and AlloSure Heart are dd-cfDNA precision medicine molecular tests which identify underlying cell injury as an indicator of organ rejection. AlloSure Kidney and AlloSure Heart coverage followed rigorous technical assessments and underscores the value of dd-cfDNA testing for transplant patient management. Both tests were validated in multicenter prospective studies published in peer reviewed journals and have a growing suite of published evidence surrounding the clinical utility of AlloSure in managing patient care.

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
347-610-7010
investor@caredx.com 


FAQ

What did CareDx announce regarding Medicare coverage on April 22, 2021?

CareDx announced that Medicare coverage for its transplant testing services remains unchanged under the new universal coverage policy by Palmetto MolDx.

How do AlloMap and AlloSure tests contribute to transplant patient care?

Both AlloMap and AlloSure tests identify organ rejection through validated dd-cfDNA precision medicine technology.

What is the significance of the new universal coverage policy for CareDx?

The policy reaffirms patient access to CareDx's transplant testing services and establishes a faster path for coverage of additional solid organs.

How widely adopted is the AlloMap test among heart transplant centers?

The AlloMap test is widely adopted by over 90% of heart transplant centers across the U.S.

What is the role of Palmetto MolDx in CareDx's services?

Palmetto MolDx finalized the local coverage determination for molecular testing related to solid organ allograft rejection, supporting CareDx's offerings.

CareDx, Inc.

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