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
2x2 grid indicating Serum Creatinine and DSA as non-invasive but less accurate diagnosis of active rejection, biopsy as a more accurate but more invasive diagnosis of active rejection, and AlloSure Kidney as a less invasive but more accurate diagnosis of active rejection.

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

Following a kidney transplant, a higher percentage of dd-cfDNA in blood in indicates injury, whereas a low percentage indicates no 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
AlloSure at varying levels provides meaningful, actionable information to your existing clinical paradigm. Distribution of AlloSure dd-cdDNA scores from over 7,000 patient samples with varying decision support levels. At 2.9%, 94% specificity for ABMR in DSA positive patients. 1%, threshold for active rejection. 5% threshold for TMCR/borderline differentiation. At .21%, 95% NPV for active rejection.

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.

The AlloSure Routine Testing Schedule (ARTS). On the ARTS timeline, patients experience monthly checkups in the first four months post-transplant. Then once at month six. Patients should then be tested once every 6 months.

CareDx: The Innovator

Setting the Standard for Kidney Transplant Surveillance

Time of Innovation In 2017 and 2018, CareDx established the ARTS protocol of 7/4/4, determined the peace of mind threshold of .21% and risk threshold of 1%, and demonstrated relevance of Relative-Change value. In 2019, CareDx launched lowest limit of detection with AlloSure 3.0, generated new AlloSure insights for dd-cfDNA utility (De-Nova DSA formation, utility in repeat transplants, BKVAN, pediatrics), and new multimodality standard with cfDNA, AI, Gene Expression Profiling. In 2020, result guidance with risk gradient, including 0.5% threshold to discriminate ambiguous rejection (RADAR study), and new biomarker tests through further innovation with HistoMap and UroMap.

KidneyCare

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

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