Currently, transplant patients have to get tissue samples from the heart checked to look for signs if their body is rejecting the organ. Such procedures can be hard to perform and risky for the patient. The new non-invasive test will save them from this ordeal.
The test was used by some laboratories previously but XDx officials said the FDA's approval will make it widely available to doctors.
Brisbane-based XDx Inc. said their test, AlloMap, measures genetic information contained in a patient's white blood cells, which are cells that help defend the body against invading viruses, bacteria or other foreign material.
The blood sample checked in the lab produces a score on the risk that a heart transplant patient will reject the new organ. Rejection occurs when a transplant recipient's body begins attacking the new organ as a foreign entity.
Half of all rejections occur in the first six weeks after transplant, and about one-quarter of recipients have evidence of rejection within the first year, the FDA said. About 2,600 heart transplants are performed in the United States each year, according to the American Heart Association.
