XDx: Medi-Cal Agrees to Cover AlloMap for Monitoring Heart Transplant Recipients [Manufacturing Close – Up]

Proquest LLC

XDx, Inc., a molecular diagnostics company that discovers, develops and commercializes non-invasive tests to monitor immune status in transplant recipients and autoimmune diseases, announced that Medi-Cal, the California State Medicaid Program and an insurer in the United States, is now covering AlloMap for its beneficiaries.

According to a release, Medi-Cal added AlloMap as a new, covered benefit, considering the test medically necessary for the surveillance of heart transplant recipients for organ rejection. AlloMap now is covered by over 200 insurers in the United States, and more than 80 percent of tests performed over the past year have been reimbursed.

"The value of AlloMap consists of its ability to non-invasively determine whether a heart transplant recipient has a low probability of rejection," noted Dr. Mario Deng, Medical Director of Heart Transplantation at Ronald Reagan UCLA Medical Center. "Utilization of AlloMap can avoid many invasive biopsies, greatly contributing to patients' quality of life."

"Medi-Cal's favorable decision is another milestone, contributing significantly to coverage of the large majority of AlloMap tests in the U.S.," noted Peter Maag, Ph.D., President and CEO of XDx. "We are proud that AlloMap is widely used as a surveillance tool post- heart transplantation and spares patients the inherent risks associated with periodic biopsies."

In the United States, the company noted, there are about 2,100 heart transplants performed each year and approximately 20,000 living heart transplant recipients. Advances in immunosuppression have improved the survival rates following cardiac transplantation, but the risk of acute cellular rejection persists for several years and is associated with graft loss. Heart transplant recipients often may undergo endomyocardial biopsies for years after transplantation. These invasive biopsy procedures may be associated with discomfort, inconvenience and infrequent but potentially serious risks of complications. AlloMap is a simple, non-invasive blood test that aids physicians in evaluating the risk for heart transplant rejection, and may reduce the need for biopsies for stable patients.

AlloMap Molecular Expression Testing is a non-invasive gene expression test 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 at the time of testing in conjunction with standard clinical assessment.