CareDx, Inc., 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 publication of pivotal clinical data for AlloSure Lung in Transplantation Direct and in Biomarker Insights.
SOUTH SAN FRANCISCO, Calif., Oct. 02, 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, today announced the publication of pivotal clinical data for AlloSure Lung in Transplantation Direct and in Biomarker Insights.
Transplantation Direct published AlloSure Lung data from the international, multi-center Lung Allograft Rejection Gene expression Observational (LARGO) Study. This study demonstrated that AlloSure Lung could identify patients with acute cellular rejection (ACR), a critical need for lung transplant patients whose only option to detect rejection is an invasive bronchoscopy. CareDx has offered AlloSure for lung transplant patients under compassionate use since February 2019 and in June 2020 submitted its AlloSure Lung dossier to Palmetto MolDx for Medicare reimbursement.
In the LARGO study, AlloSure Lung results had concurrent lung histopathology that had been assessed by a blinded consensus of an expert pulmonary pathologist panel. A total of 69 unique lung transplant patients from nine centers were examined and included histopathologic diagnoses of allograft infection, normal histopathology without infection, and ACR. The authors concluded that AlloSure Lung holds promise as a non-invasive biomarker of allograft injury with ACR in lung transplant patients.
The University of Texas San Antonio experience with AlloSure Lung was published in Biomarker Insights. This publication shared data from a group of 48 patients, in five different cohorts. The patients analyzed varied between three months and 12 years after lung transplantation. The letter from Drs. Deborah Levine, David Ross and Edward Sako supported the concept that further investigation and serial trend monitoring with AlloSure may serve valuable for assessment of lung transplantation allograft dysfunction and to preserve allograft health. These investigators emphasized the value of non-invasive testing with AlloSure Lung is especially high during the COVID-19 pandemic.
“Lung transplant patients have the lowest survival rate of any solid organ transplant, and there are few options for rejection monitoring. A non-invasive solution like AlloSure Lung becomes extremely valuable for patient care, especially in the context of the ongoing COVID-19 pandemic,” said Abbas Ardehali, MD, UCLA.
“AlloSure as a liquid bronchoscopy is game changing for lung transplant patients,” said Reg Seeto, President and Chief Business Officer at CareDx. “We have set new standards of care for heart and kidney transplant patients, and I am proud that CareDx is able to establish this same level of care for lung 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.
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