DBL Investors News
DBL Investors News
January 9, 2009
XDx and Bristol-Myers Squibb Enter into Pharmacogenomics Collaboration
Agreement Focused on Identifying Lupus Biomarkers for Orencia
BRISBANE, California, January 9, 2009 – XDx, Inc., a molecular diagnostics
company focused on noninvasive gene expression tests for the monitoring of immunemediated
conditions, announced today that it has signed a collaborative
pharmacogenomics agreement with Bristol-Myers Squibb Company (NYSE: BMY). The
collaboration is focused on identifying biomarkers in the field of Systemic Lupus
Erythematosus (SLE) for clinical diagnostic purposes associated with the clinical
development of Orencia (abatacept), a Bristol-Myers Squibb drug approved for the
treatment of rheumatoid arthritis.
Bristol-Myers Squibb will make an upfront payment to XDx in addition to milestone
payments upon the successful achievement of specific research and development
objectives. XDx will receive commercial rights to certain diagnostic applications
resulting from the collaboration.
“This collaborative agreement with Bristol-Myers Squibb further underscores our
leadership in gene expression technologies and analysis applied to molecular diagnostics
and demonstrates our ongoing commitment to patients battling serious immune-mediated
disorders such as lupus,” said Pierre Cassigneul, president and chief executive officer,
XDx. “We are pleased to be working with our new partners at Bristol-Myers Squibb and
we intend to continue leveraging our R&D, clinical, and bioinformatics capabilities
through partnerships to further demonstrate the utility of our innovative biomarker
identification technologies and diagnostic work in autoimmune disease.”
About XDx
Based in Brisbane, California, XDx is a molecular diagnostics company focused on the
discovery, development and commercialization of noninvasive gene expression-based
tests for the monitoring of transplant rejection and autoimmune diseases. The company
has developed a proprietary new method for noninvasively monitoring immune system
activity by measuring gene expression in a patient’s peripheral blood. This work is the
basis for AlloMap® Molecular Expression Testing, which provides transplant physicians
with a new tool to aid in the identification of the probability of acute cellular rejection for
post-cardiac transplant patient management.
In August 2008, XDx announced that it received market clearance from the U.S. Food and Drug Administration (FDA) for AlloMap Molecular Expression Testing. The AlloMap Test is an In Vitro Diagnostic Multivariate Index Assay (IVDMIA) test service, performed in a single laboratory, assessing the gene expression profile of RNA isolated from peripheral blood mononuclear cells (PBMC). AlloMap testing is intended 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. XDx is the first molecular diagnostics company to obtain FDA clearance of an IVDMIA for use in immunology.
XDx is evaluating its gene expression discovery and development platform for use in other immune-mediated conditions. XDx is conducting the Systemic Lupus Erythematosus Activity Gene Expression (SAGE) Study, which follows individuals with a known diagnosis of SLE for changes in disease activity during the course of one year. The goal is to develop new blood tests to help clinicians accurately predict which lupus patients will flare, when the flares will occur, and the flare severity. SLE is a systemic, chronic autoimmune disorder that affects more than 300,000 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 result in hospitalization, and by disease progression including kidney failure and damage to other organs.
Some of the AlloMap Molecular Expression Technology developed and implemented by
XDx in heart transplant patient management may be applicable to other diseases that
involve transplant rejection and the immune system. XDx’s noninvasive 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.
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