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AlloMap Heart Molecular Expression Testing 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 Heart Testing 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 of testing in conjunction with standard clinical assessment. Indicated for use in heart transplant recipients: · 15 years of age or older · At least 2 months (>55 days) post-transplant

AlloMap Heart Molecular Expression Testing 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 Heart Testing 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 Heart Testing 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 quality control, which produces gene expression data used to calculate a reported AlloMap test score - an integer ranging from 0 to 40. The Score is an algorithmic composite of the expression of 11 differentially weighted informative genes that have a role in rejection and reflect host immune response, representing multiple diverse molecular pathways. The clinician uses the AlloMap Score and other standard clinical assessments to evaluate the patient's probability of rejection and the need for additional diagnostic evaluations. 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 Heart Testing is only performed at the CLIA-certified and CAP-accredited clinical laboratory at CareDx in Brisbane, California.

AlloMap Molecular Expression Testing 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 Testing 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 heart transplant recipients: - l 15 years of age or older - I At least 2 months (>55 days) post-transplant

AlloMap Molecular Expression Testing is performed in a single laboratory (XDx Laboratories). Blood is drawn from the patient and subsequently processed, packaged and shipped frozen to the XDx Laboratory. At the XDx Laboratory, gene expression levels are determined via real time PCR for each of the test and control genes and converted to the AlloMap Test Score. The AlloMap Test Score is then reported to the physician.