What is HeartCare?

HeartCare provides a comprehensive assessment of graft rejection by combining AlloMap Heart gene expression profiling with AlloSure® Heart dd-cfDNA. AlloMap Heart assesses immune quiescence, while AlloSure Heart detects graft injury; the two tests complement each other to provide a more holistic picture of graft health.

AlloMap and AlloSure Provide Complementary Information

AlloMap and AlloSure provide complimentary information. AlloSure Heart is more beneficial around providing information regarding active injury. AlloMap is still beneficial. They work together within HeartCare as a product to provide four things, immune quiescence, active injury, ACR detection, and AMR detection.

The combination of AlloMap Heart and AlloSure Heart has a greater AUC than either test on its own¹*

The vertical axis displays sensitivity from zero to one. The horizontal axis displays specificity from zero to one. The results for AlloSure Heart, AlloMap Heart, and combined rise respectively from left to right. AUC represents ninety-five percent CI. GEP represents sixty-seven-point-seven percent. dd-cfDNA represents seventy-six-point-seven percent. Combined represents eighty-point-nine percent. The combination of AlloMap Heart and AlloSure Heart has a greater AUC than either test on its own.

How is HeartCare Used?

In clinical studies, HeartCare was administered at key internals post-transplant in order to track changes in AlloMap and AlloSure levels over time.

Heart Allograft Routine Testing Schedule (HARTS)

The Heart Allograft Routine Testing Schedule (HARTS). On the Harts timeline, patients experience monthly checkups in the first year, a total of twelve checkups in the first twelve months. In the second and third year, this frequency becomes quarterly, with checkups at fifteen, eighteen, twenty-one, twenty-four, twenty-seven, thirty, thirty-three, and thirty-six months. In the fourth and fifth year, and years thereafter, the frequency becomes biannual.
AlloMap HEART Logo

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*

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
  • AlloMap is FDA cleared

Two-year incidence of the composite primary outcome was similar between gene profiling and biopsy²

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 year² 50% did not require an EMB during the study²

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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Insurance Information

AlloMap is covered by Medicare and most private health plans.

AlloSure HEART Logo

What is AlloSure Heart?

AlloSure Heart is a simple blood test that detects injury and rejection by measuring the amount of donor-derived cell-free DNA in the blood (dd-cfDNA). When graft injury occurs, dd-cfDNA levels rise.¹

How does AlloSure Heart work?

AlloSure Heart measures dd-cfDNA and uses single nucleotide polymorphisms (“SNPs”) to distinguish between donor and recipient.

What is the clinical evidence supporting AlloSure Heart?

AlloSure Heart was clinically validated in three independent, prospective studies:

  • CARGO II—mean dd-cfDNA 2.9x greater among biopsy-proven rejection vs. quiescent samples3,4
  • Cedars-Sinai Study—in sensitized population, mean dd-cfDNA 3x greater among biopsy-proven AMR vs. biopsy-negative samples¹
  • Donor‐Derived Cell‐Free DNA‐Outcomes AlloMap Registry (D‐OAR) study¹
    • Study Design—prospective study conducted across 26 U.S. transplant centers
    • 841 plasma samples from 443 patients

D-OAR Registry Results¹

The vertical axis displays dd-cfDNA percentage from zero to one-point-five percent. The horizontal axis displays no rejection to ACR to AMR. No rejection equals eight hundred and six, ACR equals seventeen, and AMR equals eighteen. dd-cfDNA is over two times greater in the rejection groups versus the no-rejection groups. In all, for no-rejection versus all-rejection, p equals zero-point-zero-zero-five.
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