AlloMap®: Novel Non-invasive Test For Managing Heart Transplant Patients

Filed in archive Cardiovascular Health , Diagnostics , FDA Approvals on August 27, 2008

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AlloMap® - developed by XDx Inc. - is a non-invasive test utilizing molecular expression techniques that will help doctors in managing heart transplant patients after surgery to monitor organ rejection.

The FDA has cleared AlloMap® Molecular Expression Testing - making XDx Inc. the first U.S. molecular diagnostics company to obtain FDA clearance of an In Vitro Diagnostic Multivariate Index Assay (IVDMIA) for use in transplant management.

AlloMap Testing assays the RNA levels of 11 rejection biomarker genes and nine control genes. AlloMap Testing was clinically validated using data from 9 leading heart transplant centers participating in the Cardiac Allograft Rejection Gene Expression Observational (CARGO) study.

AlloMap Test has been available since January 2005 as a Laboratory Developed Test (LDT) performed in the XDx Clinical Laboratory Improvement Amendments (CLIA) certified Laboratory, and has been ordered at more than 50 U.S. transplant centers. 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.

Organ rejection is crucial to the survival of a heart transplant patients. AlloMap® offers a non-invasive way of determining if a patient's new transplanted heart is being rejected by the immune system, as opposed to heart biopies that clinicians mainly rely on.

Read more about AlloMap® and its FDA clearance from the XDx press release (pdf file) and the FDA News.

Check out this patient page detailing the testing process and health insurance information.