AlloMap molecular expression testing: Difference between revisions

Revision as of 20:31, 21 September 2017

Revision as of 21:27, 21 September 2017

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== Development ==

The test was developed using genomics and bioinformatics technologies. [[DNA microarrays]] were used to discover 252 candidate genes for which the amount of RNA in blood samples was related to rejection. Quantitative [[real-time polymerase chain reaction]] technology (qRT-PCR) confirmed 68 of the candidate genes from which the 20-gene gene expression panel was selected. The diagnostic performance was verified using independent patient samples from a multicenter clinical study.<ref name="Deng">{{cite journal |last1=Deng |first1=MC |last2=Eisen |first2=HJ |last3=Mehra |first3=MR |last4=Billingham |first4=M |last5=Marboe |first5=CC |last6=Berry |first6=G |last7=Kobashigawa |first7=J |last8=Johnson |first8=FL |last9=Starling |first9=RC |displayauthors=8|title=Noninvasive discrimination of rejection in cardiac allograft recipients using gene expression profiling |journal=American Journal of Transplantation |volume=6 |issue=1 |pages=150–60 |year=2006 |pmid=16433769 |doi=10.1111/j.1600-6143.2005.01175.x}}</ref> Initial clinical experience at three medical centers was published in 2006, confirming the efficacy and performance of the AlloMap test.<ref name="Starling">{{cite journal |last1=Starling |first1=RC |last2=Pham |first2=M |last3=Valantine |first3=H |last4=Miller |first4=L |last5=Eisen |first5=H |last6=Rodriguez |first6=ER |last7=Taylor |first7=DO |last8=Yamani |first8=MH |last9=Kobashigawa |first9=J |displayauthors=8|title=Molecular testing in the management of cardiac transplant recipients: initial clinical experience |journal=The Journal of Heart and Lung Transplantation |volume=25 |issue=12 |pages=1389–95 |year=2006 |pmid=17178330 |doi=10.1016/j.healun.2006.10.002}}</ref>

== Clinical studies==

=== CARGO Study ===

The development and clinical validation of the test used patient samples and clinical data obtained during the Cardiac Allograft Rejection Gene Expression Observational (CARGO) Study. From 2001 to 2005, 737 patients from nine U.S. transplant centers enrolled in the Study and contributed 5,834 blood samples and associated clinical data.<ref name="Deng"/> Initial clinical experience at three medical centers was published in 2006, confirming the efficacy and performance of the test.<ref name="Starling"/>

== References==