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Overview
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Clinical Utility
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Patient Support

AlloSure Kidney: For Early Detection of Allograft Injury and Rejection

Get the AlloSure Advantage to elevate transplant care for patients:

  • 100% transplant-specific cfDNA test
  • A non-invasive test
  • Superior accuracy compared to serum creatinine
  • Enables earlier detection of onset of injury
  • Analyzes SNPs across all 22 somatic chromosomes for optimizing dd-cfDNA detection

160+ U.S. Transplant Centers Use AlloSure160+ U.S. Transplant Centers use AlloSure

These Centers Represent 75% of Transplant volumeThese Centers represent 75% of transplant volume

Covered by Medicare when Coverage Criteria is MetCovered by Medicare when coverage criteria is met


AlloSure: Adding Clinical Value Beyond the Standard of Care

Associated with all Types of Kidney Allograft Rejection

Elevated levels of AlloSure were highly associated with the presence and activity of all types of kidney rejection2

Bar chart showing how elevated levels of AlloSure were highly associated with the presence and activity of all types of kidney rejection.

*Total number of events for each diagnosis.

Associated with Severity of Rejection

Elevated levels of AlloSure were highly associated with the severity of all types of rejection2

Six barcharts showing how elevated levels of AlloSure were highly associated with the severity of all types of rejection.

 

Independently Associated with Rejection

AlloSure was associated with rejection independent of standard of care parameters1

Table showing how AlloSure was associated with rejection independent of standard of care parameters.

Improved Rejection Detection

AlloSure significantly and independently improved rejection detection across many clinical scenarios and at different timepoints post-transplant1

Table showing how AlloSure significantly and independently improved rejection detection across many clinical scenarios and at different timepoints post-transplant.

 

Proven Longitudinal Testing with AlloSure

Longitudinal testing demonstrated AlloSure levels were stable in patients without rejection, rose prior to rejection, and declined in response to rejection treatment1

Graphic showing how longitudinal testing demonstrated AlloSure levels were stable in patients without rejection, rose prior to rejection, and declined in response to rejection treatment.

The median time between the two AlloSure results was 6.51 months (IQR: 2.92 – 11.73) across all patients in these analyses.

Improved Prediction of Rejection Over Standard of Care Parameters

AlloSure enhanced standard of care parameters for improved prediction of rejection1

Data plot showing how AlloSure enhanced standard of care parameters for improved prediction of rejection.

SOC Parameters = eGFR, Proteinuria, change in Sr Cr., previous episode of rejection, and DSA

AlloView Logo

AlloView is the Newest AI-derived Algorithm from CareDx

First and Only:

  • AI-derived tool to provide AlloSure-integrated view of rejection risk
  • Validated to provide risk assessment in a real world clinical setting
  • Available with AlloSure Kidney

AlloView is intended to support the healthcare provider’s independent assessment of the patient’s post transplant status. AlloView is not intended to diagnose a condition or determine a patient’s course of treatment. Clinical decisions should be based on the totality of clinical evidence, within the context of an overall clinical assessment of the individual patient and within the scope of the health care provider’s training and experience. AlloView is intended to provide an integrated view to help clinicians interpret CareDx’s proprietary laboratory developed test (LDT), AlloSure Kidney. A test result from a CareDx dd-cfDNA test is a required input of AlloView. AlloView results are clinically validated only in this context.

Learn More About AlloView

Clinical Decision Making with AlloSure Kidney

AlloSure is validated to detect ABMR and TCMR, allograft injury, and dnDSA.3,4,5,6

 

Results over 2.9% with the presence of DSAs is highly predictive of antibody-mediated rejection with a PPV of 89%.

Results below 0.21% has a 95% NPV for active rejection.

VIOLIN PLOT OF ABMR TCMR AG Injury

AlloSure is validated to inform clinical decision making based on RCV.3,7

 

Relative Change Value (RCV) is calculated between sequential AlloSure results above 0.20%.

In addition to the absolute AlloSure result, “relative change” between results is also important: increases over 149% between results may indicate a high likelihood of allograft injury.

AlloSure is validated to inform clinical decision making based on RCV.3,7

Relative Change Value (RCV) is calculated between sequential AlloSure results above 0.20%.

In addition to the absolute AlloSure result, “relative change” between results is also important: increases over 149% between results may indicate a high likelihood of allograft injury.

Graphic showing what percent levels of RCV indicate normal changes associated with biological variation, exceeds biological variation and indicate high likelihood of injury.

AlloSure is validated to inform clinical decision making based on RCV.3,7

 

 

Relative Change Value (RCV) is calculated between sequential AlloSure results above 0.20%.

In addition to the absolute AlloSure result, “relative change” between results is also important: increases over 149% between results may indicate a high likelihood of allograft injury.

Graphic showing what percent levels of RCV indicate normal changes associated with biological variation, exceeds biological variation and indicate high likelihood of injury.

AlloSure results are ready in 2-3 days for timely, informed clinical decision making.8

Turnaround time graphic showing AlloSure results are obtained in only 2-3 days.

Dr. Alexandre Loupy Discusses the AlloSure Nature Medicine Publication

AlloSure Kidney Nature Medication Publication
Watch the CareDx ATC 2024 Symposium

What is AlloSure?

AlloSure is a molecular diagnostic test for earlier detection of graft injury.

  • Non-invasive
  • More accurate
  • Earlier detection
  • Transplant specific cfDNA test
Block graphic showing what test are less invasive (Serum Creatinine, DSA) and more invasive (biopsy), with AlloSure being less invasive and more accurate than other options.

AlloSure is a simple blood test for kidney transplant organ health.

Developed specifically for transplant patients, AlloSure is a blood test that analyzes SNPs selected across all 22 somatic chromosomes to detect DNA released from a patient’s kidney allograft, known as donor-derived cell-free DNA (dd-cfDNA).

What is donor-derived cell-free DNA?

Cell-free DNA is fragments of DNA in the bloodstream that originate from cells undergoing injury and death. AlloSure can quantify increasing levels of dd-cfDNA, serving as a leading indicator of graft injury.

AlloSure is a simple blood test for kidney transplant organ health.

Developed specifically for transplant patients, AlloSure is a blood test that analyzes SNPs selected across all 22 somatic chromosomes to detect DNA released from a patient’s kidney allograft, known as donor-derived cell-free DNA (dd-cfDNA).

What is donor-derived cell-free DNA?

Cell-free DNA is fragments of DNA in the bloodstream that originate from cells undergoing injury and death. AlloSure can quantify increasing levels of dd-cfDNA, serving as a leading indicator of graft injury.

Graphic showing icon of kidney, a blood vein with dd-cfDNA and blood cells, and how higher levels of dd-cfDNA in the blood indicate injury.

An early marker of injury and rejection for kidney transplant patients.

Broad utility in:

  • High risk patients
  • Patients with allograft rejection
  • Repeat kidney transplant patients
  • Pediatric patients

Fast turnaround time of results:

  • Within three days from blood draw

An early marker of injury and rejection for kidney transplant patients.

Broad utility in:

  • High risk patients
  • Patients with allograft rejection
  • Repeat kidney transplant patients
  • Pediatric patients

Fast turnaround time of results:

  • Within three days from blood draw
Bell curve plot graphic showing where an elevated AlloSure test score indicates active rejection based on dd-cfDNA levels.

Your Dedicated Partner in Transplant Care

AlloSure isn’t just a test. CareDx supports our providers and patients by providing dedicated Patient Care Managers to facilitate appointment scheduling and blood draw logistics at no additional cost.*

Services

  • Patient Care Managers – Our Patient Care Managers include nurses and former transplant coordinators who understand the complexity in managing kidney transplant patients.
  • RemoTraC® – CareDx provides mobile phlebotomy services to patients at no additional cost* to make it easy to stay on track with routine transplant labs and AlloSure testing. Over 9k patients actively use RemoTrac.
Graphic showing female customer service representative and icons around her conveying the support CareDx provides in continuity of care, appointment reminders, appointment scheduling and mobile phlebotomy.

*CareDx provides specimen collection through mobile phlebotomists as part of its laboratory service so patients should not have additional out of pocket expenses beyond any coinsurance/deductibles required by their health plans for the test.

AlloSure Sample Collection and Draw Instructions

Watch the AlloSure specimen collection and shipping video and download step by step instructions.

Learn More

References

1 Aubert, O. et al., Cell-Free DNA for the detection of kidney allograft rejection. Nat Med (2024)
2 Clinical study data on file from Paris Transplant Group
3 Bu L et al., Kidney Int. 2022 Apr;101(4):793-803
4 Jordan SC et al., Transplant Direct. 2018
5 Stites E et al., J Am Transplant. 2020; 00:1-8
6 Bloom RD et al., J Am Soc Nephrol. 2017; 28:2221–2232
7 Bromberg JS et al., J Appl Lab Med. 2017; 2:309–321
8 TAT from sample collection day: Melancon et. al. Kidney360. Oct 2020

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