Calif.–(BUSINESS WIRE)–XDx, Inc., a molecular
diagnostics company focused on the development and commercialization of
clinically differentiated, high value non-invasive diagnostic tests to monitor
immune-mediated conditions, today announced that Highmark Inc., an independent
licensee of the Blue Cross Blue Shield Association, is now covering AlloMap®
for its beneficiaries. Highmark considers AlloMap “medically necessary” for
monitoring heart transplant rejection, recognizing the clinical benefits of a
non-invasive method for managing rejection in stable heart transplant
recipients. AlloMap now is covered for approximately two-thirds of the United States
heart transplant population.
“The addition of AlloMap testing has improved our ability to
provide quality care to heart transplant patients,” states Dr. Srinivas Murali,
Medical Director of the Cardiovascular Institute at West Penn Allegheny Health
System in Pittsburgh.
Dr. Murali is a leading expert in the treatment of heart failure and helps
direct one of the nations preeminent heart transplantation programs at Allegheny General Hospital.
Pierre Cassigneul, President and CEO of XDx, commented, “We
are very pleased with Highmarks favorable coverage decision. They join the already
200+ insurers acknowledging the clinical benefits of AlloMap, including sparing
stable patients the inherent risks associated with biopsies.”
In the United
States, 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. 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.
About AlloMap® Molecular Expression Technology
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. 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
and has been commercially available since 2005. AlloMap was cleared by the U.S.
Food and Drug Administration in 2008 and was CE marked for the European Union
in April 2011. Use of AlloMap is also included in the International Society of
Heart and Lung Transplant (ISHLT) Practice Guidelines, published in August
2010, the worldwide standard for the care of heart transplant patients.
Approximately 66% of the United
States heart transplant population is
covered for AlloMap.
XDx, Inc., based in Brisbane,
California, is a molecular
diagnostics company focused on the discovery, development and commercialization
of non-invasive gene expression-based tests for the monitoring of transplant
rejection and autoimmune diseases. The company has developed AlloMap Molecular
Expression Testing, an FDA-cleared test, which provides transplant physicians
with a tool to aid in the determination of the probability of acute cellular
rejection for post-cardiac transplant patient management. Some of the AlloMap
technology developed and implemented by XDx in heart transplant patient
management may be applicable to other conditions that involve transplant
rejection and diseases that affect the immune system. XDxs non-invasive
technology offers the potential to decrease healthcare costs and improve the
quality of life for patients with a variety of life-threatening or
life-altering immune-mediated diseases. For more information, please visit www.xdx.com.