FDA Gives Green Light to Genetic Heart Transplant Test

XDx Inc. out of Brisbane, California has received FDA approval for its “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.” Deep down, the test is a 20-gene (11 informative, 9 control) quantitative polymerase chain reaction (qRT-PCR) assay that uses RNA isolated from peripheral blood mononuclear cells.

“AlloMap is a valuable tool in the management of heart transplant patients,” said Dr. Howard J. Eisen, professor and chief of cardiology at Drexel University College of Medicine in Philadelphia. “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.”
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 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 U.S. transplant centers. The AlloMap Test may be used for stable patients aged 15 years or older at any time after the second month post-transplant. In order to maintain tight control of the testing processes, AlloMap Test is currently performed only at the XDx Reference Laboratory.

Press release: XDx’s AlloMap® Gene Expression Test Cleared by U.S. Food and Drug Administration (FDA)…
Company page: XDx Expression Diagnostics…
Presentation at the FDA: AlloMap® Molecular Expression Testing: A specific example of CLIA oversight ofa laboratory-developed test service (.pdf)…