NEW DATA FROM THE ADMIRAL STUDY – DOWNLOAD THE LANDMARK PUBLICATION

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Newly transplanted kidney patients use AlloSure

40+

Journal publications

Introducing ADMIRAL: An Independent Multicenter Analysis

Assessing Dd-cfDNA Monitoring Insights of Renal Allografts with Longitudinal Surveillance (ADMIRAL).
The largest prospective cohort of kidney transplant recipients followed for three years with over 200 biopsy-paired dd-cfDNA results.5

Participating ADMIRAL Study Centers

  • Intermountain
  • Tampa General
  • University of Colorado
  • University of Maryland
  • University of Texas Health Science
  • Virginia Commonwealth University
  • Washington University (St. Louis, MO)

62% Improvement Over Serum Creatinine in Identifying Subclinical and Clinical Rejection

AlloSure is Superior to Serum Creatinine in Detecting Biopsy-Confirmed Rejection from No Rejection*

AlloSure Detects both TCMR and ABMR

AlloSure differentiates the absence of rejection* from TCMR and ABMR.5

Unleash the Power to Predict Early Graft Injury* and dnDSA Detection

AlloSure scores rose a median of 91 days before detection of dnDSA.5

AlloSure elevations (≥0.5%) were associated with a nearly 3-fold elevation in the detection of future dn-DSA.5

*Injury defined in ADMIRAL as: Out of range tacrolimus, BK viremia, dnDSA positive, urinary tract infection, proteinuria, allograft rejection, and recurrent FSGS.

Higher AlloSure Scores Correlated with eGFR Decline

Persistently elevated AlloSure (> 1 result, >= 0.5%) has a nearly 2-fold increase in risk of >25% decline in patients’ eGFR over 3 years.5 No statistical significance within first year.

The Power of AlloSure Kidney to Predict Graft Injury, Actionable Rejection, and dnDSA Detection

Risk of clinical and subclinical rejection increases with higher AlloSure score.5-7

AlloSure is the ONLY dd-cfDNA with Validated Longitudinal Management Using Relative Change Value

Relative Change Value

In addition to the absolute value, the delta/RCV between results can be indicative of allograft injury:

  • Increases in AlloSure results over 61% exceed biological variation8
  • A median increase of 149% between serial results is indicative of graft injury (p=0.02)9

Be Empowered to Act with Early Signal of Graft Injury

AlloSure testing schedule follows established clinical rationale.

Fast result turnaround time: under three days after blood draw.

The AlloSure Routine Testing Schedule (ARTS) is based on a recommendation from the DART study. All testing should be performed when medically necessary, in accordance with the treating physician’s independent medical judgment.10

AlloSure is a Surveillance Service Superior to Serum Creatinine

What is AlloSure?

A Surveillance Solution

The first analytically and clinically validated donor derived cell-free DNA (dd-cfDNA) test developed for transplant patients with a targeted SNP assay across all somatic chromosomes.

The ONLY dd-cfDNA service clinically validated for surveillance.

An Early Marker of Injury and Rejection for Kidney Transplant Patients

Broad utility in:

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

Fast turnaround time of results:

  • Under 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.

AlloSure Resources

AlloSure Sample Collection and Draw Instructions

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

KidneyCare

Multi-modality surveillance. Comprehensive monitoring for kidney transplant patients, combining dd-cfDNA and gene expression profiling.

References

1 Hart, A. et al. OPTN/SRTR 2017 Annual Data Report: Kidney. Am J Transplant 2019; 19 ( Suppl 2): 19–123.
2 Botev R et al. Clin J Am Soc Nephrol 2009; 4:899–906.
3 Bloom RD et al. J Am Soc Nephrol 2017; 28:2221–2232.
4 Seeto, R., et. al. Biophys Rev. 2020;12(4):917-924. doi:10.1007/s12551-020-00713-5.
5 Bu L. et. al. Kidney International. 2021 Dec doi: https://doi.org/10.1016/j.kint.2021.11.034.
6 Bloom RD et al. J Am Soc Nephrol 2017; 28:2221–2232.
7 Stites E, et al. J Am Transplant, 2020; 00:1-8.
8 Bromberg JS et al. J Appl Lab Med. 2017; 2:309–321.
9 Bu L. et. al. Kidney International. 2021 Dec doi: https://doi.org/10.1016/j.kint.2021.11.034.
10 Pai A, Swan JT, Wojciechowski D, et al. Ann Transplant. 2021;26:e932249. Published 2021 Jul 2. doi:10.12659/AOT.93224.