XDx and University of Minnesota Establish Lupus Collaboration

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XDx and University of Minnesota Establish Lupus Collaboration
Tuesday February 20, 2007
Agreements Aimed at Improving Patient Management of Lupus with Molecular Diagnostics


Feb. 20 -- XDx Inc., a molecular diagnostics company, announced today that it has signed an agreement with the University of Minnesota to exclusively license key intellectual property assets in the field of Systemic Lupus Erythematosus (SLE). The license, which augments XDx's strong proprietary position in this field, relates to the use of gene expression to assess the disease status of SLE patients. The licensed intellectual property was co-invented by the research groups of Dr. Timothy Behrens, Adjunct Professor of Medicine and former Head of the Autoimmunity Program at the University of Minnesota, Dr. Emily Gillespie, Assistant Professor of Medicine at the University of Minnesota, and Dr. Peter K. Gregersen at The Feinstein Institute for Medical Research in New York.
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"XDx is pleased to build upon its relationship with the University of Minnesota, which is a leader in the field of lupus gene expression research," said Pierre Cassigneul, President and CEO, XDx. "This is a significant milestone for XDx, as it represents the company's commitment to expanding our development of innovative molecular diagnostics for immune-mediated disorders, including autoimmune diseases such as SLE."

SLE is a systemic, chronic autoimmune disorder that affects at least 240,000 people in the United States. Clinical management of patients with SLE is complicated by the recurrence of disease flares, which can vary in timing and severity and often result in hospitalization, and by disease progression including kidney failure and damage to other organs. Development of new treatments has been limited due to the lack of tools that provide insight into disease status and progression at the level of individual patients.

"Autoimmune diseases, such as SLE, represent some of the most challenging diseases from a clinical standpoint because of the vague and often overlapping symptoms," said Dr. Gillespie. "I am excited about XDx's commitment to this important clinical area, which stands to benefit greatly from novel technological advances."

XDx, the University of Minnesota, and The Feinstein Institute have also entered into a separate agreement that provides XDx access to SLE patient samples collected through an NIH-funded collaborative program to elucidate biomarkers of autoimmune diseases. XDx plans to advance the development of molecular diagnostics for lupus through the integration of these assets and technology along with demonstrated XDx expertise in the field of genomics for immune-mediated conditions.

"The innovative approach that XDx used to develop AlloMap® molecular expression testing for the management of cardiac transplant patients can be applied in the development of a diagnostic test for SLE," said Dr. Ralph Snyderman, Chancellor Emeritus and James B. Duke Professor of Medicine, Duke University, and a member of the XDx board of directors. "A major problem in the treatment of SLE is the sporadic and unpredictable nature of the disease, often leading to treatment after damage has occurred. New technologies that enable physicians to assess disease severity, anticipate flares and to make more informed therapeutic decisions would be of tremendous value."

About XDx

XDx's mission is to improve patient care by developing molecular diagnostics that translate an individual's immune status into clinically actionable information.

Founded in 2000, XDx is a molecular diagnostics company that utilizes state-of-the-art genomic technology and sophisticated bioinformatics analyses to understand and measure the immune processes that underlie specific immune- mediated conditions. Physicians can use this information to optimize patient treatment and minimize the long-term consequences of immunosuppressive therapies.

XDx's science and technology is now being evaluated in patients with solid organ transplants. Building on the discoveries made during the development of AlloMap® testing for heart transplant patients, which included the identification of many genes and pathways involved in tissue rejection, XDx is now developing a product for use by physicians to better manage lung transplant patients.

Beyond the use of AlloMap testing in assessing immune response in solid organ transplantation, XDx scientists are applying similar approaches to create new molecular diagnostic tests for the improved clinical management of immune-mediated inflammatory diseases, such as systemic lupus erythematosus (SLE or lupus,) to diagnose and predict clinical flares common in a variety of these diseases.

In addition to its potential for use by physicians for better patient management, the XDx approach is of interest to pharmaceutical companies looking to use biomarkers predictive of drug efficacy in order to proactively identify patient response and to better target their drug development efforts and clinical trials. More information can be found at www.xdx.com.

About AlloMap ®Molecular Expression Testing

The first product using this unique approach is AlloMap molecular expression testing. This service, offered through the XDx CLIA-certified clinical laboratory since January 2005, is being used by a number of leading cardiac transplant centers in the United States to monitor patients following their heart transplants. The scientific and clinical validation of this technology has been described in a peer-reviewed article published in the American Journal of Transplantation. More information can be found at www.allomap.com.




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