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AlloMap has been commercially available since 2005 as a CLIA approved Laboratory Developed Test (LDT) and was cleared by the U.S. [[Food and Drug Administration]] (FDA) in 2008 as a Class II Medical Device.<ref>http://www.accessdata.fda.gov/cdrh_docs/reviews/K073482.pdf</ref> It is available only from the XDx Reference Laboratory in Brisbane, CA.
The use of the 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>{{cite journal |last1=Costanzo |first1=MR |last2=Costanzo |first2=MR |last3=Dipchand |first3=A |last4=Starling |first4=R |last5=Anderson |first5=A |last6=Chan |first6=M |last7=Desai |first7=S |last8=Fedson |first8=S |last9=Fisher |first9=P |displayauthors=8|title=The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients |journal=The Journal of heart and lung transplantation |volume=29 |issue=8 |pages=914–56 |year=2010 |pmid=20643330 |doi=10.1016/j.healun.2010.05.034}}</ref>
== 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==
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=== IMAGE Study ===
A comparative effectiveness study, the Invasive Monitoring Attenuation through Gene Expression (IMAGE) Study, compared clinical outcomes of patients managed with AlloMap to outcomes of patients managed with endomyocardial biopsy. The study, which ran from 2005–09, included 602 patients from thirteen U.S. centers who were at least six months post-transplant. The 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>{{cite journal |last1=Pham |first1=MX |last2=Teuteberg |first2=JJ |last3=Kfoury |first3=AG |last4=Starling |first4=RC |last5=Deng |first5=MC |last6=Cappola |first6=TP |last7=Kao |first7=A |last8=Anderson |first8=AS |last9=Cotts |first9=WG |displayauthors=8|title=Gene-expression profiling for rejection surveillance after cardiac transplantation |journal=The New England Journal of Medicine |volume=362 |issue=20 |pages=1890–900 |year=2010 |pmid=20413602 |doi=10.1056/NEJMoa0912965}}</ref>
== Indications for use ==
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