Cell-free DNA is fragmented DNA originating from cells and continuously released into the bloodstream
AlloSure measures cfDNA, and uses single nucleotide polymorphisms (SNPs) to distinguish between donor and recipient.
AlloSure can quantify increasing levels of dd-cfDNA, serving as a leading indicator of graft injury
This study found that AlloSure scores were significantly elevated in the presence of acute cellular rejection (ACR).
These findings were further supported by a single center study at Stanford, which observed an elevation in AlloSure scores in the event of ACR, antibody-mediated rejection (AMR), and CLAD3:
The results of both the LARGO and Stanford studies show that the dd-cfDNA levels were significantly elevated in both ACR and obstructive phenotype CLAD. The levels of dd-cfDNA in the case of AMR were also elevated, although they did not achieve statistical significance (likely due to sample size).
Additionally, a pivotal multi-center collaboration with National Institute of Health (NIH), CareDx, Inc. and lung transplant centers at Johns-Hopkins University, University of Maryland, Inova Medical Center and University of Texas, San Antonio – the Analysis of Lung Allograft Remote Monitoring (ALARM-1) Study, has recently completed with publication in press.