eClinical Technology and Industy News

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.

Click the button below to read the entire Press Release:

Continue Reading The Press Release

Discover What Sets TrialStat Apart From Ordinary EDC Platforms

Click the image or button below to explore our eClinical Suite Platform and discover what sets TrialStat apart from competing EDC platforms.

Request Your Demo Today!

From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?