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A clear path forward: the latest innovation in kidney transplant surveillance can drive better outcomes for your patients

AlloSure is the first and only non-invasive test which assesses organ health by directly measuring allograft injury.

AlloSure is a clinically and analytically validated, non-invasive blood test that measures donor-derived cell-free DNA (dd-cfDNA), an indicator of kidney injury.

AlloSure can accurately determine active rejection, enabling better management of your kidney transplant patients.

 

Cell-free DNA: a clear biomarker

Cell-Free DNA (cfDNA) is fragmented DNA in the bloodstream that originates from cells undergoing cell injury and death.

When graft injury occurs, donor-derived cell-free DNA (dd-cfDNA) increases in the blood.

AlloSure is a powerful, non-invasive tool for kidney transplant surveillance.

What is AlloSure?

+ A sensitive, accurate, and precise measure of organ health

+ A non-invasive blood test that does not require prior genotyping of the donor or recipient

+ A rejection rule-out test that has high specificity

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The approach by CareDx enables identification of allograft DNA without requiring independent genotyping of the donor and the recipient

AlloSure: An Analytically Validated Test

AlloSure was developed by CareDx with the goal of providing consistent, reproducible, high quality information using clinical-grade sequencing. This approach has been analytically validated using external reference standards, methods-based proficiency testing, and standardized cloud-based computational analysis2.

AlloSure Features

  • Analytically validated test offered by CareDx.
  • Highly sensitive, 0.19% to 16% reportable range.
  • Does not require genotyping of donor or recipient.
  • Samples collected in Streck’s Cell-Free DNA BCT® with no additional processing or preparation required before shipping.
  • Performed in CareDx’s purpose-built, CLIA-certified, CAP‑accredited NGS laboratory.
  • Offered as a laboratory developed test.
  • Results reported within 72 hours of sample receipt at CareDx.

AlloSure is now available for order from CareDx

AlloSure is a proprietary, analytically validated test using NGS to measure levels of dd-cfDNA present in the blood of a transplant recipient.

References

1 Woodward et al., Proficiency Testing for and Surveillance of Heart Transplant Health Using Donor-Derived Cell-Free DNA. J Mol Diag 17:859. 2015.
2 Amit et al. Using Cell Free DNA Reference Standards to Evaluate the Analytical Performance of Circulating Tumor DNA Testing and Solid Organ Transplant Health Surveillance. BioTechniques. 2015 Oct; 59 (4): 248–250.

AlloSure is not available for testing samples that originate in the State of New York.