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
Transbronchial biopsies are invasive and carry risks of complications up to 25.7%, including hemorrhage (11.4%) and pneumothorax (5.5%).2,3
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.

AlloSure Lung is a Reliable Non-Invasive Marker of Allograft Injury

What is AlloSure Lung?

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 Lung can quantify increasing levels of dd-cfDNA, serving as a leading indicator of graft injury.

AlloSure Lung Clinical Data

The most published, commercially available dd-cfDNA test in lung transplantation.

What Evidence Supports dd-cfDNA in Lung Transplant?

Clinical Utility Data by Keller et al: an Independent Multi-Center Analysis

The first and only multi-center study to clinically validate the use of dd-cfDNA in lung transplantation.

AlloSure Lung Reduced Surveillance Bronchoscopies by 82%, Showing Utility as a Reliable Measure of Allograft Injury4

Estimated total of 225 fewer invasive surveillance bronchoscopies (82% reduction) within the study time frame.

AlloSure Lung is a Leading Indicator for Early Injury Identification4

Early identification leads to early intervention!

23 (8%) of the surveillance bronchoscopies were elevated dd-cfDNA (>1%) with confirmed ALAD. AlloSure Lung identified these graft injuries that would have otherwise gone unnoticed until they became severe enough to manifest symptoms.

AlloSure Lung Provides Actionable Information for Patient Management4

AlloSure Lung can help guide physicians whether bronchoscopy and biopsies may be necessary.

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


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

AlloSure Lung Offers Clear Distinction Between Injury and No-Injury4

ALAD diagnosis median dd-cfDNA was 1.7% vs 0.35% in stable patients.
Acute Lung Allograft Dysfunction (ALAD) at the time of diagnosis (n=37) versus stable patients (n=258).

AlloSure Lung Goes Beyond Rejection – Helps Identify Impactful Infections4

AlloSure Lung, along with other clinical symptoms, may be used to rule out impactful infections.

Infection was defined as the presence of lower respiratory tract infection in accordance with ISHLT consensus guidelines:

  • Positive microbiology on BAL specimens
  • Sputum samples or RT-PCR nasopharyngeal swab along with documented initiation of treatment
  • Radiographic evidence of new infiltrates on chest imaging


CareDx is Your Dedicated Partner in Transplant Care

AlloHome is a remote patient monitoring (RPM) solution designed to drive patient engagement and timely interventions for patients pre- and post-transplant. With AlloHome, patients receive Bluetooth-enabled devices to capture vital sign readings in their own homes. These devices automatically pair with a smart hub to deliver real-time data to trained professionals who monitor and track readings.


We developed a free mobile application to support transplant patients: AlloCare makes managing medications and tracking blood pressure, blood sugar, fluids, and weight easier than ever.

Other Resources


1 OPTN Data (1/29/2021)
2McWilliams TJ et al. Surveillance bronchoscopy in lung transplant recipients: risk versus benefit. J Heart Lung Transplant. 2008;27(11):1203-9.
3 Valentine et al. Single-institution study evaluating the utility of surveillance bronchoscopy after lung transplantation. J Heart Lung Transplant. 2009;28(1):14-20.
4 Keller, M. B., Sun J., Mutebi, C., Shah, P., Levine, D., Aryal, S., Iacono,A., Timofte, I., Mathew J., Varghese, A., Ginder, C., Agbor-Enoh, S. (2021). Donor-derived cell-free DNA as a composite marker of Acute Lung Allograft Dysfunction in Clinical care. Journal of Heart and Lung Transplantation,