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#REDIRECT [[Heart_transplantation#Complications]]
'''AlloMap molecular expression testing''', developed and commercialized by CareDx, formerly known as XDx, is a gene expression profiling test to identify [[heart transplantation|heart transplant]] recipients with a low probability of one type of [[organ transplant|transplant]] rejection. The test is performed on a [[blood]] sample, providing a non-invasive test to help manage the care of patients post transplant. Prior to the availability of this test, the primary method for managing heart [[transplant rejection]] was the invasive technique of endomyocardial biopsy.<ref>{{cite web | last=Thomlison | first=B | title=Success With AlloMap Molecular Expression Testing | publisher=Medical News Today | date=2007-05-12 | url=http://www.medicalnewstoday.com/articles/70268.php }}</ref>
Test results are reported as a single score indicating the probability of moderate/severe [[acute rejection|acute cellular rejection]] (ACR). The performance characteristics of the test make it best suited to help indicate that acute cellar rejection is not present. The score is based on the amount of [[RNA]] from each gene in a 20-gene panel comprising 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>{{cite journal |last1=Dedrick |first1=RL |title=Understanding gene expression patterns in immune-mediated disorders |journal=Journal of Immunotoxicology |volume=4 |issue=3 |pages=201–7 |year=2007 |pmid=18958729 |doi=10.1080/15476910701385562}}</ref>
The test score is used, along with other standard clinical assessments, to evaluate the patient’s probability of acute cellular rejection and the need for additional evaluations. This test is not designed to be informative about other forms of heart rejections such as antibody-mediated rejection (AMR) or [[cardiac]] [[allograft]] vasculopathy (CAV).
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 CareDx 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>
