Source MDx today announced a partnership with Brigham and Women's Hospital in Boston to examine RNA-based biomarkers in multiple sclerosis (MS) patients and healthy control participants unaffected by the disease. The goal of the study is to identify diagnostic markers and to determine markers of active disease (relapses) or stable disease, along with response markers for currently available MS therapies. The study will utilize Source MDx's patented gene expression profiling for the identification and monitoring of MS. The lead investigators for the study are Phil De Jager, M.D., Ph.D., Assistant Professor in the Department of Neurology at Brigham and Women's Hospital and the Harvard Medical School/Partners Healthcare Center for Genetics & Genomics, and David Hafler, M.D., Director of Molecular Immunology at Brigham and Women's Hospital and Professor of Neurology of Harvard Medical School.

Multiple sclerosis is a chronic inflammatory disease of the central nervous system and is the most common disabling neurological condition to affect young adults. The progression of the disease is unpredictable and varies from person to person. For many, the disease entails periods of complete or partial remission interspersed with an exacerbation of MS (also known as a relapse, attack or flare) that causes new symptoms. Others experience slowly worsening neurologic function from the beginning with no distinct relapses or remissions. The determination of the stage of the disease is imprecise using currently available technologies, whereas gene expression profiles may provide clear guidance on the progression of the disease and response to treatment.

"Our objective is to evaluate RNA-based markers in the broader context of each patient's genetics, protein markers, family history and clinical information in order to determine markers that can help in making a diagnosis of MS and prognosticate on drug response in MS," commented Dr. De Jager. "By doing so, we hope to be better able to identify markers that could lead to improved diagnostic tools, therapies or treatment regimen."

The study is part of ongoing research conducted by Dr. De Jager and Dr. Hafler along with colleagues at the International Multiple Sclerosis Genetics Consortium (IMSGC) and the Partners Healthcare MS Center. The IMSGC has completed the largest replicated whole genome scan for MS to date. Its data identifying two new genetic variations associated with MS was published in the New England Journal of Medicine ("Risk Alleles for Multiple Sclerosis Identified by a Genomewide Study," August 30, 2007). This large, whole genome association study has evaluated over 12,000 subjects and represents seminal work in the MS field.

Source MDx has been conducting research related to MS since 1999 and has patented the use of gene expression data to allow more accurate identification, monitoring and treatment of MS. Gene expression biomarkers independently identified and patented by Source MDx through the company's precise and calibrated approach have subsequently been shown to be genetically linked to MS susceptibility according to the work completed by Drs. De Jager and Hafler.

"We look forward to working with Brigham and Women's Hospital and furthering our ongoing research in biomarkers associated with inflammatory disease in general and MS specifically," commented Karl Wassmann, chief executive officer, Source MDx. "We believe this research will ultimately lead to improved, more targeted treatments for patients."

Although little is known about the pathogenesis of MS, it is well recognized to cluster in families and it is clear that genetic factors have an important influence over an individual's risk of developing the disease.

About Source MDx

Source MDx is a privately-held molecular diagnostics development company that uses its patented technology to monitor an individual's health, disease status and response to therapy at the molecular level, using RNA from whole blood or tissue samples. Source MDx is developing a strong portfolio of patented diagnostic biomarker panels to assist with the detection and diagnosis of cancer and other diseases. Source MDx has patented Precision Profile™ molecular diagnostic biomarkers in nine cancers including bladder, breast, cervical, colon, lung, melanoma, ovarian, pancreatic and prostate, and eight autoimmune diseases including rheumatoid arthritis, multiple sclerosis, lupus, osteoarthritis, psoriasis, Crohn's disease, transplant rejection and ulcerative colitis. The company has completed over 150 preclinical and clinical projects for more than 30 leading pharmaceutical, biotechnology and diagnostic companies.

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