AlloMap molecular expression testing: Difference between revisions

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AlloMap Molecular Expression Testing, developed and commercialized by XDx, is a gene expression profiling test that helps doctors identify [[heart transplantation|heart transplant]] recipients with a low probability of heart [[organ transplant|transplant]] rejection.

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== AlloMap Molecular Expression Testing ==

AlloMap Molecular Expression Testing, developed and commercialized by XDx, is a gene expression profiling test that helps doctors identify heart transplant recipients with a low probability of heart transplant rejection.

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The AlloMap test is performed using a [[blood]] sample, providing doctors with a non-invasive test to help manage the care of patients post transplant. Prior to the availability of AlloMap, the primary method for managing heart [[transplant rejection|transplant rejection]] was endomyocardial biopsy.

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AlloMap test results are reported as a single score, a number from 0-40, with lower scores indicating a lower probability of moderate/severe [[acute rejection|acute cellular rejection]] (ACR) at the time the test was performed. The performance characteristics of the AlloMap test make it best suited to help indicate that an acute cellar rejection is not present. The AlloMap score is based on the amount of [[RNA]] from each gene in a 20-gene panel comprising of 11 rejection-related genes and 9 genes used for normalization and quality control. Many of the rejection-related genes are associated with biological pathways involved in the [[immune]] response and rejection processes.<ref>Dedrick R. Understanding [[Gene Expression]] Patterns in Immune-Mediated Disorders. J Immunotox 2007 Jul;4(3):201-7. PMID[http://www.ncbi.nlm.nih.gov/pubmed/18958729 PMID:18958729]</ref>

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A clinician uses the AlloMap test score, along with other standard clinical assessments, to evaluate the patient’s probability of acute cellular rejection and the need for additional [[diagnostic]] evaluations. AlloMap is not designed to be informative about other forms of heart rejections such as antibody-mediated rejection (AMR) or [[cardiac]] [[allograft]] vasculopathy (CAV).

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AlloMap has been commercially available since 2005 as a CLIA approved Laboratory Developed Test (LDT) and was cleared by the [[FDA]] in 2008 as a Class II Medical Device.<ref>http://www.accessdata.fda.gov/cdrh_docs/reviews/K073482.pdf</ref>

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The use of the AlloMap test is described in the recommendations for the non-invasive monitoring of acute heart transplant rejection in the first evidence-based clinical practice guidelines for the care of heart transplant recipients issued by the International Society of Heart and Lung Transplantation.<ref>Costanzo MR et al. The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2010 Aug;29(8):914-56. [http://www.ncbi.nlm.nih.gov/pubmed/20643330 PMID: 20643330] http://www.ishlt.org/publications/guidelines.asp </ref>

== Development ==

The AlloMap test was developed using genomics and bioinformatics technologies. From approximately 25,000 – 30,000 genes in the human genome, [[DNA microarrays]] were used to discover 252 candidate genes for which the amount of RNA in blood samples was related to rejection; called candidate gene expression markers of rejection. Quantitative [[real-time polymerase chain reaction]] technology (qRT-PCR) was used to confirm 68 of the candidate genes and to develop the 20-gene AlloMap gene expression panel. The diagnostic performance characteristics of AlloMap testing were verified using independent patient samples obtained from a multicenter clinical study.<ref name="Deng">Deng MC, Eisen HJ, Mehra MR, et al. Noninvasive discrimination of rejection in cardiac allograft recipients using gene expression profiling. Am J Transplant 2006;6:150-160. [http://www.ncbi.nlm.nih.gov/pubmed/16433769 PMID: 16433769]</ref>

==Key Clinical Studies==

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Initial clinical experience at three medical centers was later published in 2006 and the data confirmed the efficacy and performance of the AlloMap test.<ref name="Starling">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):1389-95. [http://www.ncbi.nlm.nih.gov/pubmed/17178330 PMID: 17178330]</ref>

=== IMAGE Study ===

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The study results showed that AlloMap was not inferior to endomyocardial biopsy with respect to clinical outcomes when used to monitor stable, asymptomatic heart transplant patients.<ref>Pham, Michael X., Teuteberg, Jeffrey J., Kfoury, Abdallah G., Starling, Randall C., Deng, Mario C., Cappola, Thomas P., Kao, Andrew, Anderson, Allen S., Cotts, William G., Ewald, Gregory A., Baran, David A., Bogaev, Roberta C., Elashoff, Barbara, Baron, Helen, Yee, James, Valantine, Hannah A., the IMAGE Study Group. Gene-Expression Profiling for Rejection Surveillance after Cardiac Transplantation N Engl J Med 2010 0: NEJMoa0912965. [http://www.ncbi.nlm.nih.gov/pubmed/20413602 PMID: 20413602]</ref>

== Indications for Use ==

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== References==

{{Reflist}}

== External links ==

* [http://www.allomap.com/ Official Product Website]

* [http://www.xdx.com/ XDx Company Website]

[[Category:HealthMedical tests]]

[[Category:Genomics]]

[[Category:Genome]]

[[Category:DNA]]

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[[Category:Immunogenetics]]

[[Category:Quantitative genetics]]