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FDA clears gene expression test for heart transplant patients
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The FDA has granted clearance for AlloMap, a noninvasive blood test that uses molecular expression techniques to assist physicians in managing heart transplant recipients for possible post-surgery organ rejection.
AlloMap, developed by XDx Inc., measures genetic information in patients with stable allograft function who have a low probability of moderate-to-severe acute cellular rejection at the time of testing. The test specifically measures gene expression in 20 different genes — RNA levels of 11 rejection biomarker genes and nine control genes.
Physicians regularly monitor heart transplant recipients for rejection following a transplant. Heart biopsy is most often used but is risky and difficult to perform. According to the National Heart, Lung, and Blood Institute, half of all transplant rejections occur during the first six weeks after surgery, and 25% of patients have signs of possible rejection at least once during the first year following transplant.
AlloMap is indicated for stable patients aged 15 years and older at any time after the second month post-transplant. This is the third in vitro diagnostic multivariate index assay cleared by the FDA. – by Katie Kalvaitis
Heart transplant cardiologists have been searching for ways to better diagnose and manage allograft rejection for several decades. The ability to use an innovative and creative genetic expression quantification of inflammation that is, essentially, a “simple” blood test, is an exciting step forward.
Perhaps this test will decrease the hassle of endomyocardial biopsy that so many patients and clinicians have come to hate. Though there are several limitations to AlloMap, arguably including its cost and “snapshot” view of a complex and plastic clinical situation and the fact that it will be a challenge to become skilled at using the test, it is an important step forward and opens new horizons for managing this challenging patient population.
– James B. Young, MD
Cardiology Today Section Editor