Key Scientific Articles

Read these peer-reviewed articles* to find out how AlloMap is improving transplant patient management.

2016 Clinical Information

Poster presented at ISHLT 2016
CareDx at ISHLT 2016

2015 Donor-Derived Cell-Free DNA Presentations

Poster presented at AMP 2015
Proficiency Testing for and Surveillance of Heart Transplant Health Using Donor-Derived Cell-Free DNA

Late-Breaking Poster from ASN 2015
Donor-derived Cell-free DNA in Plasma Increases with Rejection and Decreases after Treatment in Kidney Transplant Recipients

AlloMap and Heart Transplantation Basics

Dedrick R. Understanding Gene Expression Patterns in Immune-Mediated Disorders. J Immunotox. 2007 Jul;4(3):201-207.

Fang K. Clinical Utilities of Peripheral Blood Gene Expression Profiling in the Management of Cardiac Transplant Patients. J Immunotox. 2007 Jul;4(3):209-217.

Hunt SA and Haddad F. The Changing Face of Heart Transplantation. J. Am. Coll. Cardiol. 2008;52: 587-598.

AlloMap Test Performance Characteristics and Decision Impact

Pham MX, Teuteberg, JJ, Kfoury, AG et al. Gene-Expression Profiling for Rejection Surveillance after Cardiac Transplantation. N Engl J Med 2010; 362:1890-1900

Supplementary Appendix. Supplementary Appendix. Pham MX et al. Gene-Expression Profiling for Rejection Surveillance after Cardiac Transplantation.

Gene expression profiling distinguishes a molecular signature for grade 1B mild acute cellular rejection in cardiac allograft recipients. J Heart Lung Transplant 2007;26(12):1270-1280.

Deng MC, Eisen HJ, Mehra MR, et al. Noninvasive discrimination of rejection in cardiac allograft recipients using gene expression profiling. Am J Transplant. 2006 Jan;6(1):150-160.

Starling RC, Pham M, Valantine H, et al. Molecular testing in the management of cardiac transplant recipients: initial clinical experience. J Heart Lung Transplant. 2006 Dec;25(12):1389-1395.

AlloMap Score Variability

Deng MC, Elashoff B, Pham MX et al., Utility of Gene Expression Profiling Score Variability to Predict Clinical Events in Heart Transplant Recipients. Transplantation. 2014 doi: 10.1097/01.tp.0000443897.29951.cf

AlloMap recommended in ISHLT guidelines

Costanzo MR, Dipchand A, Starling RC et al., The International Society of Heart and Lung Tranplantation Guidelines for the care of Heart Transplant Recipients. J Heart Lung Transplant. 2010;29 (8):914-956

Health Economics

Evans RW, Williams GE, Baron HM, et al. The economic implications of noninvasive molecular testing for cardiac allograft rejection. Am J Transplant. 2005 Jun;5(6):1553-8.

Limitations and Risks of biopsies

Crespo-Leiro MG, Zuckermann A, Bara C, Mohacsi P, Schulz U, Boyle A et al. Concordance Among Pathologists in the Second Cardiac Allograft Rejection Gene Expression Observational Study (CARGO II). Transplantation 2012;94(11):1172-1177

Hamour IM, Burke MM, Bell AD et al. Limited Utility of Endomyocardial Biopsy in the First Year after Heart Transplantation. Transplantation . 2008;85(7): 969–974.

Tan CD, Baldwin WM, Rodriguez R. Update on Cardiac transplant Pathology. Heart Transplant Pathology 2007;131:1169-1191

Stehlik J, et al. Utility of Long-term Surveillance Endomyocardial Biopsy: A Multi-institutional Analysis. J Heart Lung Transplant. 2006;25:1402–1409.

Marboe CC, Billingham ME, Eisen HJ, et al. Nodular endocardial infiltrates (Quilty lesions) cause significant variability in diagnosis of ISHLT Grade 2 and 3A rejection in cardiac allograft recipients. J Heart Lung Transplant. 2005 Jul;24(7 Suppl):S219-26

Kirklin, J. Is biopsy-proven cellular rejection an important clinical consideration in heart transplantation? Current Opinion in Cardiology. 2005 Mar; 20(2):127-131

Key AlloMap Clinical Trials and Studies

Deng MC, Elashoff B, Pham MX et al., Utility of Gene Expression Profiling Score Variability to Predict Clinical Events in Heart Transplant Recipients. Transplantation. 2014 doi: 10.1097/01.tp.0000443897.29951.cf

Austin BA, Arnold PJ, Kao A. The Impact of Time Post Cardiac Transplant on Gene Expression Profile Scores, An Analysis of 32,043 Tests. J Cardiovasc Dis Diagn. 2013; 1(3) 114. doi:10.4172/jcdd.1000114

Gene Expression Profiling as a Noninvasive Method to Monitor for Cardiac Allograft Rejection. Technol Eval Cent Assess Program Exec Summ. 2011 Nov;26(8):1-3

Mehra MR, Parameshwar J. Gene Expression Profiling and cardiac allograft rejection Monitoring: Is IMAGE just a mirage? J Heart Lung Transplant. 2010;29(6):599-602

Mehra MR, Uber PA, Benitez RM. Gene-based bio-signature patterns and cardiac allograft rejection. Heart Fail Clin 2009;6(1):87-92.

Cadeiras M, Shahzad K, John MM et al. Relationship between a validated molecular cardiac transplant rejection classifier and routine organ function parameters. Clin Transplant .2009

Mehra MR, Uber PA, Walther D et al. Gene expression profiles and B-type natriuretic peptide elevation in heart transplantation: more than a hemodynamic marker. Circulation 2006;114(1 Suppl):I21-26.

Deng MC, Eisen HJ, Mehra MR, et al. Noninvasive discrimination of rejection in cardiac allograft recipients using gene expression profiling. Am J Transplant. 2006 Jan;6(1):150-160.

Mehra MR, Kobashigawa MD, Deng MC, et al. Clinical Implications and Longitudinal Alteration of Peripheral Blood Transcriptional Signals Indicative of Future Cardiac Allograft Rejection. J Heart Lung Transplant. 2008 Mar;27(8):297-301.

Yamani MH, Taylor DO, Rodriguez ER, et al. Transplant vasculopathy is associated with increased AlloMap gene expression score. J Heart Lung Transplant. 2007 Apr;26(4):403-6.

Yamani MH, Taylor DO, Haire C, Smedira N et al. Post-transplant ischemic injury is associated with up-regulated AlloMap gene expression. Clin Transplant 2007;21(4):523-525.

Mehra MR, Kobashigawa MD, Deng MC, et al. Transcriptional Signals of T-cell and Corticosteroid-sensitive Genes are Associated with Future Acute Cellular Rejection in Cardiac Allografts. J Heart Lung Transplant. 2007 Dec;26(12):1255-1263

Crespo-Leiro MG, Zuckermann A, Bara C, Mohacsi P, Schulz U, Boyle A et al. Concordance Among Pathologists in the Second Cardiac Allograft Rejection Gene Expression Observational Study (CARGO II). Transplantation 2012;94(11):1172-1177

Pham MX, Teuteberg, JJ, Kfoury, AG et al. Gene-Expression Profiling for Rejection Surveillance after Cardiac Transplantation. N Engl J Med 2010; 362:1890-1900

Supplementary Appendix. Supplementary Appendix. Pham MX et al. Gene-Expression Profiling for Rejection Surveillance after Cardiac Transplantation.

Cell-free DNA Transplantation Key Articles

Lo,Y.M. D. Transplantation Monitoring by Plasma DNA Sequencing. Clinical Chemistry 57:7 941–942 (2011). The Lancet 351(9112), 1329-1330.

Snyder, T. M., Khush, K. K., Valantine, H. A., & Quake, S. R. (2011). Universal noninvasive detection of solid organ transplant rejection. PNAS 108(15), 6229-6234.

Beck, J., Bierau, S., Balzer, S., Andag, R., Kanzow, P., Schmitz, J., & Schütz, E. (2013). Digital droplet PCR for rapid quantification of donor DNA in the circulation of transplant recipients as a potential universal biomarker of graft injury. Clin Chem 59(12), 1732-1741.

Hidestrand, M., Tomita-Mitchell, A., Hidestrand, P. M., Oliphant, A., Goetsch, M., Stamm, K., .. & Mitchell, M. E. (2013). Highly Sensitive Non-Invasive Cardiac Transplant Rejection Monitoring Using Targeted Quantification of Donor Specific Cell Free DNA. JACC 63(12), 1224-1226.

Iwijn De Vlaminck et al. Circulating Cell-Free DNA Enables Noninvasive Diagnosis of Heart Transplant Rejection. Sci Transl Med 6, 241ra77 (2014);DOI: 10.1126/scitranslmed.3007803

Iwijn De Vlaminck et al.Supplementary Materials for Circulating Cell-Free DNA Enables Noninvasive Diagnosis of Heart Transplant Rejection. Sci Transl Med 6, 241ra77 (2014) DOI: 10.1126/scitranslmed.3007803

Recent Posters and Abstracts (See Abstract Bibliography)

*Some content of these publications contain information that is currently under investigation and has not been cleared by the FDA as safe and effective. The FDA’s AlloMap Decision Summary is available here.

Intended Use:

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.

Indications for Use:

Indicated for use in heart transplant recipients:

  1. 15 years of age or older
  2. At least 2 months (≥55 days) post-transplant