AlloMap™ molecular expression testing, developed by XDx, uses a blood sample to measure immune activation at a cellular level, which detects the absence of acute cellular rejection in cardiac transplant patients.
AlloMap testing has been clinically validated to determine the absence of rejection in heart transplant patients beginning six months post-transplant by the Cardiac Allograft Rejection Observation (CARGO) study. Howard J. Eisen, M.D., Chief of Cardiology at Drexel University College of Medicine, was a co-principal investigator in the four-year clinical trial and co-first author on the study’s publication earlier this year in the American Journal of Transplantation (January 2006). Drexel has been successfully and routinely monitoring more than 100 patients with AlloMap testing since March 2005. In addition to treating patients, Dr. Eisen, one of the country’s most experienced transplant cardiologists, is currently presenting his findings to other physicians across the United States. Most recently, Dr. Eisen presented the Drexel experience using AlloMap testing at the World Transplant Congress on July 24, 2006, in Boston.
“The ability to measure the responsiveness of the immune system through a simple blood test is an incredible advance in managing heart transplant patients from both a clinical and a quality-of-life perspective,” said Dr. Eisen. “We now have over one year of real-world experience with the test, and the results are robust and reproducible. Molecular testing may largely eliminate biopsy after one year. Additionally, we are beginning to see success with the test at six months to one year post-transplant.”
Marjorie Sprague, a patient of Dr. Eisen’s who received a heart transplant in 2005, began having regular biopsies to monitor her new heart until Dr. Eisen recommended trying AlloMap testing in January of this year.
“Biopsy is an invasive and uncomfortable procedure, so when Dr. Eisen told me about AlloMap testing I was thrilled,” said Sprague. “If you have the choice between biopsy and AlloMap testing, in which only a blood draw is required, you will choose the blood draw – believe me. For someone with an active lifestyle, it makes all the difference.”
Using a blood sample, the test enables physicians to objectively monitor a patient’s immune system and identify an increased risk of rejection before the rejection actually occurs. Prior to the availability of AlloMap testing in January 2005, heart transplant patients had to undergo numerous invasive, subjective and anxiety-producing biopsies to monitor for rejection of the new heart. When rejection was finally detected, tissue damage had already occurred.
“It is exciting to be able to offer my patients a more comfortable and reliable diagnostic tool,” Dr. Eisen said. “As AlloMap testing continues to be adopted by more and more clinics and people continue to recognize its benefits, I believe it will become the standard practice in all cases, including clinical trials.”
About AlloMap™ Molecular Expression Testing
AlloMap molecular expression testing is a noninvasive method for detecting the absence of rejection in heart transplant recipients. The test translates the complex signals of the immune system’s multiple genes and pathways, specifically those associated with heart transplant rejection, into an objective, actionable score. AlloMap testing enables clinicians – for the first time – to monitor the immune system early. AlloMap testing was developed using specimens and data collected in a landmark multi-center, observational study known as Cardiac Allograft Rejection Gene Expression Observational (CARGO) study. In addition, clinical trials are currently underway to collect specimens and data to develop and validate an AlloMap test for lung transplant patients. The company also plans to evaluate the utility of this technology in autoimmune conditions such as lupus and Crohn’s disease. More information can be found at www.allomap.com or www.xdx.com.