CareDx Starts Enrollment in MAPLE, a Multi-modal, Multi-center, Prospective Study of LiverCare
CareDx, Inc. (CDNA) has initiated the Molecular Assessment and Profiling of Liver Transplant Recipients (MAPLE) Study at Mount Sinai Hospital, enrolling the first patient. This multi-center study will evaluate the LiverCare platform, which utilizes various testing methodologies including donor-derived cell-free DNA and gene expression profiling to assess liver allograft status. The study aims to enroll 1500 liver transplant recipients and underscores CareDx's commitment to advancing care in transplant medicine.
- Initiation of MAPLE Study to assess LiverCare platform.
- Enrollment of the first patient demonstrates progress in liver transplant care.
- Potential to establish new methodologies for monitoring liver transplant recipients.
- Risks associated with the study's success and the effectiveness of LiverCare may not meet expectations.
Study to demonstrate utility of LiverCare post-transplant surveillance for liver transplant recipients
SOUTH SAN FRANCISCO, Calif., June 01, 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, today announced the enrollment of the first patient in the Molecular Assessment and Profiling of Liver Transplant Recipients (MAPLE) Study at Mount Sinai Hospital in New York.
MAPLE is a multi-center, prospective study of the LiverCare platform, a novel multi-modality approach to assess the status of liver allografts. LiverCare will include the following:
- AlloSure® Liver — donor-derived cell-free DNA-based measure of organ injury
- AlloMap® Liver — gene expression profiling assessment of recipient immune system activity
- AlloHeme™ Liver — blood-based micro-chimerism surveillance solution
- HistoMap Liver — tissue-based gene expression profiling assessment of allograft rejection and injury
- AlloID™ — blood-based metagenomic infectious disease identification
In addition, LiverCare includes a proprietary machine learning algorithm to predict allograft outcomes based on clinical parameters.
The study, which was first announced earlier this year, will enroll 1500 liver transplant recipients and marks the beginning of CareDx’s work in liver transplant. The first enrolled patient demonstrates the continued momentum behind the study and CareDx’s commitment to patient care across transplant organ types.
“MAPLE will help us define the application of multi-modality testing in liver transplant,” said Dr. Sham Dholakia, Senior Vice President of Medical Affairs at CareDx. “As leaders in transplantation, CareDx was first to market with surveillance tests supported by clinical data in kidney and heart, and we are leading in lung. We will continue to invest in clinical data development and follow the science in support of transplant patients.”
“We are excited to work with CareDx on the MAPLE Study,” said Dr. Sander Florman, MAPLE’s Principal Investigator and the Director of the Recanati/Miller Transplantation Institute. “Having seen the clinical data supporting use of CareDx’s tests in heart, kidney, and lung transplant, we are highly interested to study the potential benefits for the management of liver transplant patients.”
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.
Forward Looking Statements
This press release includes forward-looking statements, including statements regarding the Company’s continued enrollment in the LiverCare study and the potential benefits of MAPLE. 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 numerous risks and uncertainties, including risks that the CareDx does not realize the expected benefits of the enrollment; 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, 2020 filed by CareDx with the SEC on February 24, 2021 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
Greg Chodaczek
646-924-1769
investor@caredx.com
FAQ
What is the MAPLE Study by CareDx?
How many patients will be enrolled in the MAPLE Study?
What technologies are included in the LiverCare platform?
When was the first patient enrolled in the MAPLE Study?
What is the significance of the MAPLE Study for CareDx?
