Molecular diagnostics developer XDx Wednesday received FDA market clearance from for its AlloMap, a noninvasive, multi-gene molecular diagnostics blood test used to help identify heart transplant recipients least likely to suffer from tissue rejection.
"AlloMap can help contribute to an appropriate treatment plan by identifying those patients not experiencing post-operative heart transplant rejection," said Daniel G. Schultz, MD, director of the FDA's Center for Devices and Radiological Health.
The Brisbane, Calif.-based XDx said its AlloMap measures genetic information contained in the white blood cells from a patient's blood sample.
According to the National Heart, Lung and Blood Institute, half of all possible rejections happen during the first six weeks after surgery and 25 percent of patients have signs of possible rejection at least once during the first year following a transplant.
AlloMap is the third in vitro diagnostic multivariate index assay (IVDMIA) cleared by the FDA. IVDMIAs are medical devices that combine the values of multiple variables to yield a single, patient-specific result.