What Is AlloSure® Kidney?

AlloSure is a donor-derived cell-free DNA (dd-cfDNA) test for noninvasive transplant surveillance, providing a direct measure of organ injury.

  • More accurate than serum creatinine or DSA testing1
  • Noninvasive

How Does AlloSure Kidney Work?

Cell-free DNA is fragmented DNA originating from cells and continuously released into the bloodstream.


AlloSure Kidney 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.

What Are the Key Benefits of AlloSure Kidney?
  • Only dd-cfDNA test with clinical validation in prospective, multicenter trial
  • With over 30 publications, more clinical data than any dd-cfDNA test including in re-transplant and pediatric patients3
  • Developed specifically for transplant patients, utilizes SNPs from across 100% of somatic chromosomes
  • Lowest level of detection and fastest turnaround time of any dd-cfDNA test2
  • Broadly covered, including by Medicare and other insurance plans

AlloSure Surveillance Provides Actionable Information for Patient Management

High NPV gives peace of mind to physicians and patients4.

  • High PPV for ABMR in DSA+ patients5
  • Differentiates borderline/TCMR1A patients6
  • 95% NPV at 0.21% threshold7

How Is AlloSure Used?

Establishing a baseline AlloSure reading allows comparison against subsequent tests. The study conducted by Bromberg, et al. established a 61% reference value (RCV) for AlloSure8

  • A serial increase in AlloSure up to 61% may be attributed to normal biological variation
  • A serial increase in AlloSure greater than 61% exceeds expected biological variation

The DART study established the AlloSure Routine Testing Schedule (ARTS). The schedule ensures testing at key clinical time points post-transplant and then quarterly surveillance testing9.

CareDx: The Innovator

Setting the Standard for Kidney Transplant Surveillance

KidneyCare

Multi-modality surveillance. Comprehensive monitoring for kidney transplant patients, combining dd-cfDNA, and gene expression profiling, and machine learning driven prognostic assessment.