FDAnews Device Daily Bulletin

FDA Clears Test to Help Doctors Manage Heart Transplant Patients

Aug. 28, 2008

The FDA has cleared XDx’s AlloMap, a noninvasive test that uses molecular expression techniques to help doctors manage heart transplant patients post-surgery for potential organ rejection.

Following a heart transplant, physicians regularly monitor patients for transplant rejection, a significant risk to patient survival. Clinicians often rely on heart biopsy to gauge whether a patient is rejecting the transplanted heart, but these biopsies are difficult to perform and can be risky for the patient, according to the FDA.

To counter this risk, the test measures gene expression to create a score that indicates whether a heart transplant patient is likely to reject the new organ. This is accomplished by measuring genetic information contained in white blood cells from a patient's blood sample.