What is AlloMap?

AlloMap is an innovative diagnostic test that helps identify patients with stable allograft function who have a low probability of moderate to severe acute cellular rejection (ACR) at the time of testing  in conjunction with standard clinical assessment.*

Roger W, Heart transplant recipient

How does AlloMap Work?

The AlloMap test is derived from a panel of 20 genes, 11 informative and 9 genes used for normalization and quality control, which produces gene expression data used in the calculation of an AlloMap score. This score is associated with activity of the recipient immune system, and a lower score is associated with a quiescent allograft.

What are the Benefits of AlloMap?

AlloMap allows for noninvasive surveillance of heart transplant recipients. It is used by over 90% of transplant centers, and since approval has been used over 150,000 times in nearly 30,000 patients.

Benefits
  • High NPV for ruling out rejection
  • The Invasive Monitoring Attenuation through Gene Expression (IMAGE) study published in the New England Journal of Medicine, showed GEP-based rejection monitoring is non-inferior to routine biopsies with respect to the composite outcomes and had similar overall survival at 2 years.
  • Class IIa, level B recommendation by the International Society for Heart and Lung Transplantation (ISHLT) guidelines. This is the highest level of recommendation of any heart surveillance tool in the guidelines.
  • FDA cleared
  • FDA’s decision summary document

Two-year Incidence of the Composite Primary Outcome was Similar Between Gene Profiling and Biopsy1

  • The 2-year cumulative rates of rejection with hemodynamic compromise, graft dysfunction from other causes, death, or retransplantation were similar in the gene profiling and biopsy group (14.5% vs. 15.3%).
  • The study was designed to determine whether rejection monitoring with gene profiling was non-inferior to routine biopsies for the prevention of rejection with hemodynamic compromise, graft dysfunction, death, or retransplantation.
  • The primary analysis was a comparison between the groups of the time to first occurrence of the composite outcome, using the hazard ratios calculated from a Cox proportional hazards model on the intention-to-treat (all randomized patients) population. Both the Kaplan-Meier method and Cox proportional hazard models were used to estimate event rates.
  • The interaction effects of strategy group-by-center and strategy group-by-month post-transplantation at randomization were tested at an alpha level of 0.15.
Two-year incidence of the composite primary outcome was similar between gene profiling and biopsy. The 2-year cumulative rates of rejection with hemodynamic compromise, graft dysfunction from other causes, death, or retransplantation were similar in the gene profiling and biopsy group, fourteen-point-five percent versus fifteen-point-three percent. The study was designed to determine whether rejection monitoring with gene profiling was non-inferior to routine biopsies for the prevention of rejection with hemodynamic compromise, graft dysfunction, death, or retransplantation. The primary analysis was a comparison between the groups of the time to first occurrence of the composite outcome, using the hazard ratios calculated from a Cox proportional hazards model on the intention-to-treat (all randomized patients) population. Both the Kaplan-Meier method and Cox proportional hazard models were used to estimate event rates. The interaction effects of strategy group-by-center and strategy group-by-month post-transplantation at randomization were tested at an alpha level of zero-point-one-five. Eighty-seven percent of patients in the GEP arm had two or fewer EMBs per patient year. Fifty percent did not require an EMB during the study.

87% of Patients in the GEP Arm Had 2 or Fewer EMBs Per Patient Year1 50% Did Not Require an EMB During the Study1

The frequency of EMBs was reduced from 3.0 EMBs/pt year in the EMB arm to 0.5 in the GEP arm (p < 0.001).

The vertical axis displays the number of patients, from zero to one hundred and fifty. The horizontal axis displays the number of biopsies per year, from zero to less-than or equal to six. The frequency of EMBs was reduced from 3.0 EMBs per year in the EMB arm to 0.5 in the GEP arm. P is less than zero-point-zero-zero-one percent. AlloMap is covered by Medicare and most private health plans. Eighty-seven percent of patients in the GEP arm had two or fewer EMBs per patient year. Fifty percent did not require an EMB during the study.

How do You Interpret AlloMap Results?

AlloMap uses a 0-40 reporting scale.

Negative Predictive Value (NPV)
Each test score is associated with an NPV that is the probability that the patient does not have current rejection. For example, an AlloMap test score of 35 is associated with an NPV of 98.7% that indicates a 98.7% estimated probability that the patient is not experiencing current rejection.

Positive Predictive Value (PPV)
Similarly, each test score is associated with a PPV, which is the probability that the patient does have acute cellular rejection (ACR) at the time of testing. The AlloMap test has a comparatively low PPV (relative to its NPV), and therefore, an AlloMap test score should not be used to “rule in” ACR.

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AlloMap Sample Collection and Draw Instructions

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

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Insurance Information

AlloMap is covered by Medicare when coverage criteria is met. Commercial coverage varies.