Watch the HeartCare specimen collection and shipping video and download step by step instructions.
New ISHLT Guidelines Support Use of CareDx’s HeartCare Solutions, AlloMap and AlloSure, in Routine Monitoring of Heart Transplant Patients – Read More
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.
In clinical studies, HeartCare was administered at key internals post-transplant in order to track changes in AlloMap and AlloSure levels over time.
Watch the HeartCare specimen collection and shipping video and download step by step instructions.
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*
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.
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.
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.
Watch the AlloMap specimen collection and shipping video and download step by step instructions.
AlloMap is covered by Medicare and most private health plans.
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
AlloSure Heart measures dd-cfDNA and uses single nucleotide polymorphisms (“SNPs”) to distinguish between donor and recipient.
AlloSure Heart was clinically validated in three independent, prospective studies: