Unmet need in Lung Transplant

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Lung transplant recipients experience one of the lowest median survivals (6.7 years) of any solid organ transplants, with a 5-year survival of 59%¹.
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Lung transplant recipients have an increased incidence of chronic organ rejection, termed “Chronic Lung Allograft Dysfunction” (CLAD).
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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.
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There are no clinically available biomarkers for noninvasive detection of graft rejection, infection or CLAD; therefore, diagnosis has usually been dependent on invasive bronchoscopy and biopsy procedures.

What is AlloSure Lung?

  • 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 validated and is now reimbursed for both kidney and heart transplant recipients.
  • AlloSure Lung represents a noninvasive and desperately needed solution for the surveillance of lung transplant recipients.

How Does AlloSure Lung Work?

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

Following a lung transplant, a higher percentage of dd-cfDNA in blood in indicates injury, whereas a low percentage indicates no injury.

What is the Clinical Evidence Supporting AlloSure Lung?

AlloSure Lung was clinically validated in a multi-center study – the Lung Allograft Rejection Gene Expression Observational (LARGO) study2– which included 9 transplant centers and 69 patients:

LARGO study Chart. AlloSure Lung levels amongst patient groups. Chart shows dd-cfDNA % with groups including INFXN: Lung Allograft Associate Infection, NORMAL: Healthy Patients, and ACR: Acute Cellular Rejection.

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:

Stanford study chart. AlloSure Lung levels amongst patient groups. Chart shows dd-cfDNA % in logarithmic scale with groups including STABLE: Healthy Patients, INFXN: Lung Allograft Associate Infection, AMR: Antibody Mediated Rejection, ACR: Acute Cellular Rejection, and CLAD: Chronic Lung Allograft Dysfunction.

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.

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%.

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

AlloSure at varying levels provides meaningful, actionable information to your existing clinical paradigm. Distribution of AlloSure dd-cdDNA scores from 673 patient samples shows quiescence with dd-cfDNA levels below 0.50%. Elevation up to .85%, and Injury at 1.00%.

Future Availability

  • While AlloSure Lung is not currently commercially available, it is undergoing rigorous review by the Centers for Medicare & Medicaid Services (CMS) MolDx program to obtain coverage for lung transplant patients.
  • AlloSure Lung can currently be obtained on a compassionate use basis; for more information please reach out to info@stage.caredx.com.