NIH Study Shows Using CareDx’s AlloSure Lung for Transplant Surveillance is More Effective than Diagnostic Bronchoscopy at Identifying Rejection
ALARM Study Publication Shows Use of AlloSure for Home-Based, Non-invasive Surveillance Monitoring Can Provide a Safer Option for Lung Transplant Recipients Navigating the COVID-19 Pandemic
Excerpt from the Press Release:
SOUTH SAN FRANCISCO, Calif., Jan. 07, 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 results of a study led by the National Institutes of Health (NIH), published in The Journal of Heart and Lung Transplantation¹, “Donor-derived Cell-free DNA as a Composite Marker of Acute Lung Allograft Dysfunction in Clinical Care,” that validates the ability of AlloSure® Lung to detect signs of organ rejection and infection in asymptomatic lung transplant recipients in a real-world, home-based surveillance setting. The use of AlloSure Lung also identified episodes of acute rejection and infection that would have been missed using a biopsy strategy alone.
ALARM (Lung Allograft Remote Monitoring) was a real-world, multicenter, prospective study conducted from March 24 to September 1, 2020, at the height of the pandemic. Four lung transplant centers used AlloSure Lung donor-derived cell-free DNA (dd-cfDNA) instead of surveillance bronchoscopy for transplant rejection surveillance in a home-based setting using CareDx RemoTraC™, an at-home blood draw phlebotomy service.
The study showed that non-invasive AlloSure Lung effectively identified acute cellular rejection (ACR), antibody-mediated rejection (AMR), and infection in asymptomatic lung transplant patients during routine surveillance screening. For diagnosis of ACR, AMR, or infection in these patients, dd-cfDNA yielded a sensitivity of 73.9%, specificity of 87.7%, positive predictive value of 43.4%, and negative predictive value of 96.5%, with an area under the curve (AUC) of 0.82 using the ALARM investigator’s protocol. Using an AlloSure Lung surveillance strategy, there were 83% fewer invasive biopsies than would have been performed under a surveillance biopsy program.
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