XDx, a molecular diagnostics company, has reported that the California Technology Assessment Forum (CTAF) has agreed that AlloMap meets all five Technology Assessment Criteria for safety, effectiveness and improvement in health outcomes when used to manage heart transplant patients at least one year post-transplant.
AlloMap is a patented, gene expression test that uses a simple, noninvasive method of blood sample collection and can be used to indicate the low probability of acute cellular rejection in stable heart transplant recipients.
AlloMap testing measures the expression levels of 20 genes from a blood sample. The combined expression of these genes is represented as an AlloMap test score.
AlloMap is performed in the XDx CLIA-certified laboratory. It has been commercially available since 2005 and was cleared by the US Food and Drug Administration in 2008.
XDx president and CEO Pierre Cassigneul said that CTAF’s independent and unbiased recommendations are an important decision-making resource for clinicians and patients, and the CTAF recommendation further validates AlloMap as an important alternative to invasive endomyocardial biopsy in the management of stable heart transplant recipients one that can have a significant impact on patient quality of life.