Benzinga | Jan 7, 2022 01:02PM EST

CareDx Highlights National Institutes Of Health Study Showed Co.'s AlloSure 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

SOUTH SAN FRANCISCO, Calif., Jan. 07, 2022 (GLOBE NEWSWIRE) -- CareDx, Inc. (NASDAQ:CDNA) -- The Transplant Company(tm) 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(r) 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(tm), 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.

"Few patients are more vulnerable during the pandemic than lung transplant recipients who are not only on immunosuppressive medications, but having a higher infection risk than any other organ transplant population," said Reg Seeto, CEO and President of CareDx. "The NIH study findings were achieved in real-world, home-based settings using our RemoTraC mobile phlebotomy service. This is a big step forward for non-invasive surveillance of lung transplant recipients."

"As investigators on the ALARM study, which was a real-world, multicenter prospective study, we saw first-hand how AlloSure Lung can effectively monitor lung transplant patients for signs of rejection from the safety of their homes, which is especially important as these patients are much more susceptible to serious complications if infected with COVID-19," said Dr. Shambhu Aryal, MD, FCCP, Medical Director, Lung Transplant Program and Director, Inova Sarcoidosis Center, Inova Medical Group. "Additionally, the use of a non-invasive blood test helps physicians reduce the number of surveillance bronchoscopies. This is important for lung transplant patients because around 5% of lung biopsies result in pneumothorax, or a collapsed lung, with more than half of them requiring chest tube drainage, which is a serious complication that can result in extended hospitalization and an increased risk of infections."

AlloSure Lung's ability to offer early warnings to physicians of possible infection or organ rejection can help inform timely therapeutic interventions. Lung transplant patients have one of the lowest median survivals of any solid organ transplant recipient, with a five-year survival rate of approximately 53%.² Introduced in October 2021, AlloSure Lung has already been adopted in over 20 lung transplant centers.³