CareDx Demonstrates Potential of AlloHeme and AlloCell for Allogeneic Cell Transplant and Therapy Monitoring at Transplantation & Cellular Therapy Meetings

CareDx Announces that OTTR Patient Management Software Now Validated for SMART on FHIR

SOUTH SAN FRANCISCO, Calif., April 22, 2022 (GLOBE NEWSWIRE) — CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced the presentation of new data during the Tandem Meetings, Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR being held on April 23-26 in Salt Lake City, Utah, highlighting the capabilities of AlloHeme™ and AlloCell for allogeneic cell transplant and therapy monitoring.  

CareDx will also share information about its OTTR® Patient Management Software that has recently been validated to SMART (Substitutable Medical Applications, Reusable Technologies) on FHIR (Fast Healthcare Interoperability Resource) standards and is available for customer use.

“CareDx has led the way in setting new standards of care for solid organ transplant monitoring, and we’re excited to share the latest data on how our innovative solutions in development are poised to improve the care of patients receiving allogeneic hematopoietic stem cell transplants or being treated with allogeneic cell therapies,” said Reg Seeto, CEO and President of CareDx. “AlloCell is being used by leading developers of allogeneic CAR T-cell therapies to non-invasively monitor the expansion and persistence of therapies in development, and through the ACROBAT study, our ultra-sensitive AlloHeme chimerism testing solution is being evaluated for its potential in monitoring stem cell transplant patients to enable the earlier detection of disease relapse and timely therapeutic interventions.” 

“The ACROBAT study is designed to demonstrate the role of AlloHeme in routine post allogeneic HCT patient monitoring,” said Dr. Stefan O. Ciurea, Professor of Clinical Medicine and Director of the Hematopoietic Stem Cell Transplantation and Cellular Therapy Program at the University of California Irvine’s Chao Comprehensive Cancer Center, and the lead Principal Investigator of the study. “With AlloHeme, we can measure chimerism levels more accurately with much higher sensitivity than the currently widely used STR-based testing methods. The ACROBAT study is assessing the role of AlloHeme for universal early relapse detection, potentially enabling better therapeutic interventions to prevent disease relapse post-transplant and improved treatment outcomes.” 

CareDx is advancing its product pipeline with new scientific innovations for blood cancers that will help monitor treatment response after allogeneic hematopoietic stem cell transplantation (Allo-HSCT) using AlloHeme and after allogeneic cell therapy using AlloCell.

Kashif Rathore, Senior Vice President of Digital Business at CareDx added, “We’re also proud to have successfully partnered with Cerner, a leader in health integration technologies, in validating our OTTR software to SMART on FHIR endpoints and we look forward to offering this new service to customers.”

Data being presented:

Title: AlloCell Provides a Highly Accurate, Sensitive, and Universal Solution for Monitoring Expansion and Persistence of Allogeneic Cellular Therapies.
Abstract #: 298
This abstract shows that AlloCell is a highly sensitive and precise method for universal detection and quantification of engineered and non-engineered allogeneic cell therapies.

Title: Advances in Chimerism Monitoring Using NGS Technology – Design of the ACROBAT Multicenter Clinical Trial
Abstract #: 565
This abstract highlights the prospective, multi-center, observational clinical trial designed to evaluate the role of AlloHeme testing to monitor for relapse in patients post allo-HCT.

Title: Analytical Evaluation and STR Comparison of the Accurate and Sensitive Microchimerism Monitoring Tool for Relapse Prediction Post-Allogeneic HCT
Abstract #: 435
This abstract highlights the analytical performance of AlloHeme, an ultra-sensitive chimerism detection solution, and demonstrates the high accuracy and sensitivity of AlloHeme in detecting chimerism compared to short tandem repeat (STR).

Title: SMART on FHIR Aligns an EHR with the Transplant-Specific Database
Abstract#: 591
This abstract highlights the collaboration between CareDx and Cerner to develop and validate the CareDx OTTR software to support transplant data electronic health record integration in line with public SMART/FHIR API user interface standards. SMART FHIR integration functionality between Cerner and CareDx OTTR software promotes an enhanced user experience allowing clinical resources to be more closely aligned with direct patient care. 

About CareDx – The Transplant Company
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.

Forward Looking Statements
This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the potential benefits and results that may be achieved with AlloHeme™, AlloCell, OTTR Patient Management Software’s validation to SMART on FHIR standards (the “Software Validation”), and CareDx’s presentation of data at the upcoming Transplantation & Cellular Therapy Meetings (the “Data Presentation”). These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of AlloHeme, AlloCell, Software Validation, or Data Presentation; risks that CareDx fails to advance its product pipeline with new scientific innovations for blood cancers that will help monitor treatment response after Allo-HSCT using AlloHeme and after allogeneic cell therapy using AlloCell; risks that CareDx fails to present data and share information as identified in this press release; general economic and market factors; and other risks discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed by CareDx with the SEC on February 24, 2022, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

CONTACTS:
CareDx, Inc.
Sasha King
Chief Marketing Officer
415-287-2393
sking@caredx.com 

Investor Relations
Ian Cooney
(415) 722-4563
investor@CareDx.com