NEW YORK (GenomeWeb News) – XDx today said that the California Technology Assessment Forum has recommended the use of its AlloMap gene expression test.
The Brisbane, Calif.-based firm said that CTAF, which is a non-profit entity sponsored by Blue Shield of California to assess new and emerging medical technology, agreed that AlloMap met all five technology assessment criteria for safety, effectiveness, and improvement in health outcomes.
The test was cleared by the US Food and Drug Administration in 2008 and is used to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection. It is used in conjunction with a standard clinical assessment.
"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," Pierre Cassigneul, president and CEO of XDx, said in a statement.