XDx Launches Non-Invasive Test to Enable Better Management of Heart Transplant Patients

Data at ISHLT Meeting Shows Clinical Management Benefits of AlloMap Testing

April 6, 2005

PHILADELPHIA, April 6 /PRNewswire/ -- XDx, Inc., a molecular diagnostics company, today announced the launch of an innovative test for the management of heart transplant patients. AlloMap(TM) molecular expression testing is a non-invasive method to monitor a patient's immune system that, unlike conventional methods, identifies the risk of tissue damage and rejection before it occurs and may enable physicians to proactively manage immunosuppressive medications.

At the International Society for Heart and Lung Transplantation (ISHLT) 25th annual meeting, April 6-9 in Philadelphia, Pa., data demonstrating the benefits of AlloMap testing is being presented by leading transplant physicians. In addition, XDx is sponsoring a symposium at which six experts from top U.S. transplant centers will discuss the impact of molecular diagnostics on transplantation and provide an update on current clinical trials for AlloMap testing in lung transplantation.

"AlloMap testing is one of the most significant advances we've seen in organ transplantation because it actually detects rejection before any damage is done," said Howard Eisen. M.D., chief of the division of cardiology at Hahnemann University Hospital and director of the Center for Advanced Heart Failure Care at Drexel University College of Medicine (Philadelphia, Pa.). "It will enable us to reduce biopsies and the potential adverse events associated with an invasive procedure, and to use less anti-rejection medication, thereby avoiding complications. AlloMap testing promises to deliver a tremendous improvement in a patient's quality of life post-transplant."

As one of the first practical applications of the human genome project, AlloMap testing translates the complex signals of the immune system's multiple genes and pathways into an objective, clinically actionable score that indicates a patient's risk for rejection. XDx's proprietary technology non-invasively monitors the immune system by measuring gene expression in a patient's peripheral blood. From a simple blood sample collected from the patient, complex gene information is extracted, analyzed and translated into a single score that provides objective information to help physicians better manage and treat patients.

The clinical value of AlloMap testing for heart transplant patients was demonstrated in a landmark multi-center, prospective, validation study known as the Cardiac Allograft Rejection Gene Expression Observational (CARGO) study.

ISHLT Presentation Highlights

• Daniel Bernstein, M.D., co-director of the Lucile Packard Children's Hospital at Stanford University Hospital, will present data demonstrating that AlloMap testing can help classify patients with evidence of mild organ rejection into high and low risk groups. This is significant because there has been long-standing uncertainty over how patients with mild rejection on biopsy should be treated and managed and with the additional information AlloMap testing provides, patients at higher risk can be treated appropriately by their physicians, while low-risk patients can avoid unnecessary biopsies and immunosuppression.
• The current clinical practice for monitoring heart transplant rejection is endomyocardial biopsy, a procedure where a small sample of tissue is clipped from the heart and analyzed by a pathologist for evidence of rejection. However, biopsy is a highly variable and controversial diagnostic test. One source of confusion found on biopsy results is what is known as a Quilty lesion, a little-understood pattern of inflammatory cells. While not considered an indicator of organ rejection, Quilty lesions are often confused with severe rejection, leading to inappropriate therapy and often to complications. Charles Marboe, M.D., vice president of pathology at Columbia University, will present data showing that AlloMap testing can distinguish between transplant rejection and quiescence (a stable or inactive state) independent of Quilty lesions. His research shows that patients with Quilty lesions have unique gene expression patterns in their blood that AlloMap testing can identify. Furthermore, the data shows that AlloMap molecular testing may be more reliable than pathology in assessing rejection status in patients.
• Corticosteroids, a key component of post-transplant immunosuppressive therapy, are potent medications with a number of side effects (e.g., weight gain, mood swings, osteoporosis, diabetes). These effects can be reduced during the first year following transplantation by gradually lowering the dose of corticosteroids. Randall Starling, M.D., M.P.H., section head at the Cleveland Clinic Heart Center, will present data demonstrating that certain genes used in AlloMap testing showed a significant correlation to corticosteroid use, which was reflected in the resulting score. These findings suggest that AlloMap testing is not only reliable for detecting rejection independent of corticosteroid dose, but that it could also be used to monitor patient response to corticosteroids, thus helping physicians optimize the medication dose.
• In a poster presentation, Dr. Eisen will introduce 19 patient case studies that demonstrate the clinical utility of AlloMap testing in providing longitudinal data that enables physicians to determine how a patient's body is reacting to a transplanted heart over time.

In addition to current marketing of AlloMap testing for heart transplant rejection and ongoing clinical trials in lung transplant patients, XDx plans to apply the technology to other transplanted organs and various autoimmune disorders.

"Molecular diagnostics can and are beginning to have a major, life-changing impact on the field of transplantation with the recent introduction of AlloMap testing," said Pierre Cassigneul, chief executive officer, XDx. "In addition to its value in the transplant setting, this technology offers the potential to improve the management and quality of life of patients with a variety of life-threatening diseases such as lupus and Crohn's disease."

To develop AlloMap testing, XDx evaluated more than 25,000 gene sequences and, using microarray and real-time polymerase chain reaction (PCR) technology to measure gene expression, developed a 20-gene algorithm that is specifically correlated with rejection. The AlloMap test translates gene expression information into a single, actionable score.

For more information about AlloMap testing and the presentations listed above, visit XDx at booth #312 at the ISHLT annual conference.

About XDx Inc.

Founded in 2000, XDx Inc. is a molecular diagnostics company based in South San Francisco, Calif. Setting the stage for a new era in personalized medicine, XDx is one of the first companies to develop and commercialize practical applications built on insights from the Human Genome Project. The company has developed a proprietary new method for non-invasively monitoring the immune system by measuring gene expression in a patients' peripheral blood. The technology offers the potential to decrease healthcare costs and significantly improve the quality of life for patients with a variety of life-threatening or life-altering, immune-mediated diseases. More information can be found at www.xdx.com or www.allomap.com.

About AlloMap(TM) Molecular Expression Testing

AlloMap molecular expression testing is a non-invasive method for determining the risk 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, identifying the risk of tissue damage before it occurs, and to manage immunosuppressive therapy proactively. The clinical value of AlloMap testing was demonstrated in a landmark multi-center, prospective study known as Cardiac Allograft Rejection Gene Expression Observational (CARGO). In addition, clinical trials are currently underway to determine the value of AlloMap testing in lung transplantation. The company also plans to evaluate the utility of this technology in autoimmune conditions such as lupus and Crohn's disease.

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This article posted April 29, 2005.