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XDx Gets FDA OK for Heart Transplant Molecular Dx Test

NEW YORK (GenomeWeb News) – XDx announced today that the US Food and Drug Administration has cleared for marketing the firm’s AlloMap multi-gene molecular expression test for heart transplant patients.
The non-invasive test is used in conjunction with standard clinical assessment to aid physicians in identifying heart transplant recipients with stable allograft function who have a low probability of moderate to severe acute cellular rejection at the time of testing. The AlloMap test includes 11 rejection biomarker genes and nine control genes, said XDx.
The Brisbane, Calif.-based firm noted that it is the first company to receive FDA clearance of an In Vitro Diagnostic Multivariate Index Assay for use in transplant management. It is the third such assay clearaed by the agency, following the February 2007 clearance of Agendia’s MammaPrint test and Pathwork Diagnostic’s Tissue of Origin test last month.
“This clearance and the FDA’s focus on this field underscore the growing importance of molecular diagnostics in the care of patients,” XDx President and CEO Pierre Cassigneul said in a statement.
XDx has been offering the test through its CLIA-certified lab since January 2005. The firm said the test was validated using data from nine heart transplant centers participating in the Cardiac Allograft Rejection Gene Expression Observational study.