CareDx Announces Publication of Pivotal AlloSure Lung Data

Rhea-AI Summary

CareDx, Inc. (Nasdaq: CDNA) announced pivotal clinical data publications for AlloSure Lung, a non-invasive biomarker for acute cellular rejection (ACR) in lung transplant patients. The LARGO study, involving 69 patients, demonstrated AlloSure's effectiveness in identifying ACR without invasive procedures. Additionally, the University of Texas San Antonio published findings from a cohort of 48 patients, emphasizing the tool's value for monitoring allograft dysfunction, especially during the COVID-19 pandemic. Experts highlight AlloSure Lung as a promising advancement in transplant care.

Positive

• AlloSure Lung shows promise as a non-invasive biomarker for detecting acute cellular rejection in lung transplant patients.
• The LARGO study included a robust sample size of 69 patients across multiple centers.
• Publications support the clinical utility of AlloSure Lung in monitoring transplant health.
• AlloSure Lung's importance is heightened during the COVID-19 pandemic.

Negative

• None.

LARGO and The University of Texas Health Science Center at San Antonio publications demonstrate benefits of AlloSure in lung transplant patients

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.

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 AlloSure Lung by CareDx?

AlloSure Lung is a non-invasive biomarker designed to detect acute cellular rejection in lung transplant patients.

What were the findings of the LARGO study related to AlloSure Lung?

The LARGO study demonstrated that AlloSure Lung could effectively identify acute cellular rejection without invasive procedures, involving 69 patients.

How many patients were studied in the University of Texas San Antonio findings?

The University of Texas San Antonio study analyzed data from 48 lung transplant patients.

When did CareDx begin offering AlloSure for lung transplant patients?

CareDx has offered AlloSure for lung transplant patients under compassionate use since February 2019.

Why is AlloSure Lung significant during the COVID-19 pandemic?

AlloSure Lung provides a non-invasive solution for monitoring lung transplant rejection, which is especially valuable during the challenges posed by the COVID-19 pandemic.