EXPLORE 5 REASONS WHY ALLOSURE IS THE LEADER IN KIDNEY TRANSPLANT

Overview
Clinical Utility
Patient Support
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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

Many Lab and Clinical Reasons for AlloSure Use

Traditional Diagnostic Testing Can Be Lagging or Unreliable Rejection Markers

Traditional Diagnostic Testing Can Be Lagging or Unreliable Rejection Markers

Many Clinical Reasons to Consider
AlloSure Testing

Many Clinical Reasons to Consider AlloSure Testing

AlloSure Delivers Precise Assessment of Rejection Risk

The AlloSure Solution: Transforming Transplant Care Through Robust Clinical Evidence and Rigorous Validation

Timeline of Key Milestones

Rigorously Validated, Highly Accurate, and Broadly Adopted
5 Reasons Why

Proven to Increase Rejection Yield in For-Cause Biopsies9

Proven to Increase Rejection Yield in For-Cause Biopsies

Compared to biopsies for other reasons, biopsies guided by elevated AlloSure found more rejection (48% vs. 29%) and less ATI/ATN (12% vs. 22%).

Median AlloSure levels in dd-cfDNA-guided biopsies: 1.51%.

Shown to Predict Formation of dnDSA 3 Months Ahead of Detection8

Shown to Predict Formation of dnDSA 3 Months Ahead of Detection

Elevated AlloSure results (results ≥ 0.5%) were associated with a nearly 3-fold increase in the detection of future dnDSA.

Validated to Detect ABMR and TCMR, Allograft Injury, and dnDSA4,5,8

Validated to Detect ABMR and TCMR, Allograft Injury, and dnDSA

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

Results over 1% and DSA MFI ≥ 2500 have a PPV of 93.7% to detect both types of rejection.

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

 

Validated to Inform Clinical Decision Making Based on RCV3,8

Validated to Inform Clinical Decision Making Based on RCV

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.

Demonstrates Superiority Over Serum Creatinine of 62% in Identifying Subclinical and Clinical Rejection8

Demonstrates Superiority Over Serum Creatinine of 62% in Identifying Subclinical and Clinical Rejection

Proven to Increase Rejection Yield in For-Cause Biopsies

Compared to biopsies for other reasons, biopsies guided by elevated AlloSure found more rejection (48% vs. 29%) and less ATI/ATN (12% vs. 22%).

Median AlloSure levels in dd-cfDNA-guided biopsies: 1.51%.

Shown to Predict Formation of dnDSA 3 Months Ahead of Detection

Elevated AlloSure results (results ≥ 0.5%) were associated with a nearly 3-fold increase in the detection of future dnDSA.

Validated to Detect ABMR and TCMR, Allograft Injury, and dnDSA

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

Results over 1% and DSA MFI ≥ 2500 have a PPV of 93.7% to detect both types of rejection.

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

 

Validated to Inform Clinical Decision Making Based on RCV

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.

Demonstrates Superiority Over Serum Creatinine of 62% in Identifying Subclinical and Clinical Rejection

Timely Results For Informed Clinical Decision Making

AlloSure kidney results delivered within 2-3 days.

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

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.

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

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

*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.

Download the AlloCare App

AlloSure Kidney Resources

AlloSure Sample Collection and Draw Instructions

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

Learn More
EDUCATIONAL RESOURCES

EDUCATIONAL RESOURCES

Download the ADMIRAL publications
VIDEO

VIDEO

Learn about Dr. Potter’s experience with AlloSure

Read the ADMIRAL publication
Get familiar with the DART Study

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References

1 Hart A et al. Am J Transplant 2019; 21 Suppl 2: p. 21–137
2 Bloom RD et al. J AM Soc Neph 2017; 28:2221-2232
3 Bromberg JS et al. J Appl Lab Med. 2017; 2:309–321
4 Jordan SC et al. Transplant Direct 2018
5 Stites E, et al. J Am Transplant, 2020; 00:1-8
6 Kant S. et al. Transplant Direct. 2020; 6(11): e622
7 Puliyanda et al. Pediatr Transplant. 2021;25(2):e1385
8 Bu L. et. al. Kidney International. 2021 Dec doi: https://doi.org/10.1016/j.kint.2021.11.034
9 Weir et al. Enhanced Histologic Yield and Actionable Findings When Biopsy is Guided by Donor-Derived Cell-Free DNA (dd-cfDNA). Am J Transplant 2022. (Abstract)
10 Obrisca B et al. Scientific Reports. 2022;12(1):15061
11 Dandamudi R et al. Clin J Am Soc Nephrol. 2022;17(11):1646-1655
12 TAT from sample collection day: Melancon et. al. Kidney360 Oct 2020