XDx Develops Blood Tests To Identify Lupus Biomarkers

XDx Inc. (Brisbane, CA, USA), a molecular diagnostics company focused on noninvasive gene expression tests for the monitoring of immune-mediated conditions, has signed a collaborative pharmacogenomics agreement with Bristol-Myers Squibb (New York, NY, USA). The collaboration is focused on identifying biomarkers in the field of Systemic Lupus Erythematosus (SLE) for clinical diagnostic purposes.

Bristol-Myers Squibb will make an upfront payment to XDx plus milestone payments upon the successful achievement of development objectives. XDx will receive commercial rights to certain diagnostic applications resulting from the collaboration.

In August 2008, XDx received market clearance for an in vitro diagnostic multivariate index assay (IVDMIA), for use in immunology from the U.S. Food and Drug Administration (FDA; Rockville, MD, USA). The assay, called AlloMap, is a molecular expression test service performed in a single laboratory. It assesses the gene expression profile of RNA isolated from peripheral blood mononuclear cells (PBMC).

XDx is evaluating the gene expression discovery and development platform for use in other immune-mediated conditions. It is conducting a 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.

Pierre Cassigneul, president and chief executive officer, XDx said, "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."

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