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XDx receives market clearance from the FDA for its AlloMap gene expression test for heart transplant recipients.

XDx, Inc., Brisbane, CA, announced it has received market clearance from the US Food and Drug Administration (FDA) for AlloMap Molecular Expression. The AlloMap Test is a noninvasive, multi-gene molecular diagnostics blood test used to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection at the time of testing, in conjunction with standard clinical assessment. XDx is the first US molecular diagnostics company to obtain FDA clearance of an In Vitro Diagnostic Multivariate Index Assay (IVDMIA) for use in transplant management.

"AlloMap is a valuable tool in the management of heart transplant patients," said Howard Eisen, MD, professor and chief of cardiology at Drexel University College of Medicine in Philadelphia, PA. "As a simple blood test, AlloMap can be used on an ongoing basis to help to determine which heart transplant patients are the least likely to suffer from rejection, which is a key factor in the long-term well being and treatment of these patients."

XDx says AlloMap Testing assays the RNA levels of 11 rejection biomarker genes and nine control genes. AlloMap Testing was clinically validated using data from 9 leading heart transplant centers participating in the company's Cardiac Allograft Rejection Gene Expression Observational (CARGO) study. AlloMap test has been available since January 2005 as a Laboratory Developed Test (LDT) performed in the XDx Clinical Laboratory Improvement Amendments (CLIA) certified laboratory, and has been ordered at more than 50 US transplant centers.

The test may be used for stable patients aged 15 years or older at any time after the second month post-transplant. XDx says the AlloMap test is currently only performed at the company's Reference Laboratory in order to maintain tight control of the testing processes.

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Publication:Transplant News
Date:Sep 1, 2008
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