Overview

AlloMap Testing: Answering Unmet Needs in Heart Transplant Surveillance

AlloMap® is a non-invasive blood test that uses genomic technologies to identify the absence of cardiac rejection.  When used in conjunction with standard clinical assessments, AlloMap may help identify patients with stable allograft function who have a low probability of moderate to severe acute cellular rejection (ACR) at the time of testing.

AlloMap is a panel of 20 gene assays, 11 informative and 9 used for normalization and/or quality control, which produces gene expression data used in the calculation of an AlloMap test score – an integer ranging from 0 to 40. Compared with patients in the same post-transplant period, the lower the score, the lower the probability of acute cellular rejection at the time of testing.

AlloMap testing is performed at the CLIA-certified and CAP accredited clinical laboratory at the CareDx® headquarters based in Brisbane, California.

Answering unmet needs in heart transplant surveillance

  • Helps patients avoid the pain, stress, and anxiety associated with biopsies
  • Provides clinicians with a non-invasive means to obtain quantifiable, objective, and reproducible results

Widely used and accepted since 2005

  • Evidence based
  • Included in the ISHLT Guidelines for Care of Heart Transplant Recipients

 

AlloMap has been used in over:

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patient results

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patients managed

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insurance companies covering the test

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transplant centers utilizing AlloMap

Download the complete Clinical Monograph for detailed information on AlloMap.

Want to learn more about AlloMap? on our upcoming Clinical Workshops to get an in-depth overview of AlloMap for healthcare providers.

Intended Use
AlloMap® is an In Vitro Diagnostic Multivariate Index Assay (IVDMIA) test service, performed in a single laboratory, assessing the gene expression profile of RNA isolated from peripheral blood mononuclear cells (PBMC). AlloMap is intended to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (ACR) at the time of testing in conjunction with standard clinical assessment.

Indicated for use in patients:

  • 15 years of age or older
  • At least 2 months (≥55 days) since transplantation

Special Considerations
AlloMap performance characteristics were established with samples from patients at least 15 years of age.

Effect of corticosteroid dosage
Systemic corticosteroid dosage of >20 mg/day of prednisone or equivalent may artificially decrease the AlloMap score [Starling et al., 2006].

Following rejection therapy
The CARGO study excluded all samples from patients who had received rejection therapy within the past 21 days. The performance characteristics of AlloMap testing in such samples, therefore, have not been established.

Following transfusion
The CARGO study excluded all samples from patients who had received a transfusion within the past 30 days. The performance characteristics of AlloMap testing in such samples, therefore, have not been established.