XDx Wins FDA Clearance for New Gene Expression Test
US-based molecular diagnostics company XDx has received market clearance from the FDA for AlloMap molecular expression testing.
According to the company, 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 or severe acute cellular rejection at the time of testing, in conjunction with standard clinical assessment.
AlloMap testing assays the RNA levels of 11 rejection biomarker genes and nine control genes. AlloMap testing was clinically validated using data from nine heart transplant centers participating in the cardiac allograft rejection gene expression observational study.
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.
XDx claims to be the first US molecular diagnostics company to obtain FDA clearance of an in vitro diagnostic multivariate index assay for use in transplant management.
Pierre Cassigneul, president and CEO of XDx, said: “The FDA clearance further demonstrates the clinical relevance and benefit of AlloMap testing in assessing the potential risk of rejection in heart transplant patients.”