XDx received a $12.5 million senior secured multidraw term loan facility from GE Capital, Healthcare Financial Services. The financing provides XDx with working capital to expand the commercialization of its FDA-cleared noninvasive AlloMap® Molecular Expression Testing and pursue the development of other gene expression-based tests for immune-mediated inflammatory diseases.
AlloMap is used to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate-to-severe acute cellular rejection at the time of testing. It received FDA sanction in August 2008, has been available since January 2005 as a laboratory-developed test performed in XDx’ CLIA-certified lab, and reportedly been ordered by more than 50 U.S. transplant centers.
AlloMap Testing assays the RNA levels of 11 rejection biomarker genes and nine control genes with a blood test. This composite score is an integer ranging from 0 to 40 and discriminates between the absence or presence of moderate-to-severe acute cellular rejection. The AlloMap Test may be used for stable patients aged 15 years or older at any time after the second month post-transplant.
XDx is currently developing tests for use in kidney transplants. It is also reportedly working on diagnostics for Crohn disease, lupus, multiple sclerosis, rheumatoid arthritis, and Sjögren syndrome.