Now Commercially Available

Unmet Need in Lung Transplant

Lung transplant recipients experience one of the lowest median survivals of any solid organ transplants, with a 5-year survival of 53%¹.
Lung transplant recipients have an increased incidence of chronic organ rejection, termed “Chronic Lung Allograft Dysfunction” (CLAD).
Lung Infection Icon
There is an increased frequency of respiratory infectious complications due both to the intimate contact of the lung graft and outside environment, and more intensive immunosuppressive regimens to forestall rejection.

Noninvasive and Accurate Measure of Lung Injury

AlloSure is a donor-derived cell-free DNA (dd-cfDNA) test for noninvasive transplant surveillance, providing a direct measure of organ injury, that has been successfully clinically validated and is now reimbursed for both kidney and heart transplant recipients.

Clinically Validated Across Multiple Studies

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

What Evidence Supports dd-cfDNA in Lung Transplant?

In two papers published by Dr. Agbor-Enoh and colleagues at the National Institutes of Health (NIH) in 2018 and 2019 respectively research demonstrated that dd-cfDNA levels were seen to both elevate preceding a clinical diagnosis of AMR (figure on left), and to predict lung transplant outcomes and FEV-1 decline (figure on right).2,3

What is the Clinical Evidence Supporting AlloSure Lung?

AlloSure Lung was clinically validated in a multi-center study – the LARGO study4 – which included 9 transplant centers and 69 patients:

This study found that AlloSure scores were significantly elevated in the presence of acute cellular rejection (ACR). These findings were further supported by a Stanford study, which observed an elevation in AlloSure scores in the event of ACR, antibody-mediated rejection (AMR), and CLAD5:

Additionally, the Levine et al. publication also found an elevation of AlloSure scores in the event of rejection, as well as a threefold elevation of the infection cohort vs. the stable group – this relationship continues to be investigated.6

The results of the LARGO, Stanford, and Levine studies show that the dd-cfDNA levels were significantly elevated in cases of rejection and injury. The Stanford study additionally showed that dd-cfDNA levels were also elevated in the case of AMR, although they did not achieve statistical significance (likely due to limited sample size).

Additionally, a not yet published 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 further investigates the utility of AlloSure in the surveillance of lung transplant recipients.

AlloSure Surveillance Provides Actionable Information for Patient Management

AlloSure Lung provides peace of mind that injury is unlikely with dd-cfDNA levels below 0.5%7,8.*

*The severe injury category indicates a higher risk of allograft rejection, while DSA formation and other allograft injury can occur at lower levels.

AlloSure Lung can help guide physicians whether bronchoscopy with lavage and biopsies may be necessary when dd-cfDNA levels are elevated.