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Tufts-New England Medical Center And Source MDx Will Collaborate To Investigate The Clinical Use Of RNA-based Biomarkers To Monitor RA Disease Status And Response To Therapy

11/9/2006 11:12:34 AM

BOSTON, and BOULDER, Colo., Nov. 9 /PRNewswire/ -- Tufts-New England Medical Center and Source MDx, Boulder, CO., a molecular diagnostics company, announced today a collaboration to develop a molecular diagnostic test for Rheumatoid Arthritis. Researchers at Tufts-NEMC, led by co-principal investigator, Tim McAlindon, MD, Chief of Rheumatology at Tufts-NEMC, will manage the clinical studies for a molecular diagnostic test that will characterize Rheumatoid Arthritis patients and their response to anti-TNF therapy. Source MDx will provide gene expression analysis of whole blood samples from the approximately 100 participating patient population based on its patented RA Precision Profile(TM) gene panel designed to diagnose and monitor RA patients and its Healthy Normals Reference dataset. Lisa Siconolfi, Ph.D., Director, Clinical Studies is the co-principal investigator for Source MDx.

"A test that provides the earliest warning of disease activity can help prompt appropriate therapy to mitigate long-term damage," said Tim McAlindon, M.D. "The earlier Rheumatoid Arthritis is detected and treated the less permanent joint damage a patient will have."

In conjunction with the Tufts-NEMC study, Source MDx also announced today that it has been awarded a Small Business Innovation Research (SBIR) grant by the National Institutes of Health (NIH) to initiate the development of a molecular diagnostic test using biomarkers to predict responders and non- responders to anti-tumor neurosis factor therapy for Rheumatoid Arthritis. "We are pleased that the National Institutes of Health continues to recognize the potential impact of Source MDx's enabling technology in the development of RNA-based molecular diagnostics," said Lisa Siconolfi, Ph.D. "In particular, it is gratifying that others in the scientific field appreciate the importance of Source MDx's precise gene expression and ability to compare to a healthy normal range when developing clinical applicable biomarkers of disease," she continued. The grant provides over $195,000 in funding over a one-year period. This is the sixth SBIR grant Source MDx has received.

Rheumatoid Arthritis or RA is a severe chronic inflammatory disease characterized by inflammation in the lining of the joints. It is a common form of inflammatory arthritis and the most disabling, affecting 0.8 percent of the adult population worldwide. Incidence in the US is about 25 per 100,000 for men and 54 per 100,000 persons for women and accounts for an estimated 250,000 hospitalizations and 9 million physician visits each year. Annually in the US, medical costs and indirect expenses due to lost wages for RA are estimated at over $3 billion In addition, less than 50 percent of working age adults with RA remain employed 10 years after disease onset. Mortality rates for people with RA are double that of the general population.

RA causes permanent joint damage with joint deformities and loss of function. The clinical course of the disease is unpredictable, as sudden exacerbations or spontaneous remissions are characteristic of the disease. Joint destruction in RA begins within a few weeks of symptom onset; therefore, quick and effective treatment decreases the rate of disease progression. Given that current tests lack adequate predictive value, Source MDx will address the need for a simple, low-cost screening and monitoring test that can predict an RA patient's future course and response to treatment. A predictive test will allow early intervention before significant joint and/or organ deterioration has occurred and will allow adjustment of medications that are/are not effective. Source MDx will use the SBIR funds to begin to develop a test that identifies patients that will respond best to a defined treatment regimen beginning with characterizing patient response anti-TNF therapy.

By analyzing biomarkers in whole blood collected from RA patients, Source MDx has already been able to discriminate healthy individuals from patients with RA. Using the same process of patented biomarker analysis Source MDx will address treatment effectiveness, to determine if a therapy is moving the patient towards a more healthy expression profile. The development of useful RNA-based biomarkers for molecular diagnostics has been inhibited in the past by the inability to measure gene expression with sufficient precision, as well as the presumption that gene expression is too variable within and between individuals. Source MDx's patented assay technology enables the measurement of gene-expression responses with high precision, which is necessary to give data clinical utility. The proprietary technology has been able to define disease- specific biomarker patterns in blood for several diseases and is therefore well-positioned to define biomarkers for patient response to TNF-alpha therapy. In addition, the Source MDx database of healthy normals provides a normal reference range for which to compare biomarker analysis in disease (US patent no. 6,960,439).

About Source MDx

Source MDx uses its patented molecular diagnostic system 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 markets over 20 patented disease and pathway-specific biomarker panels that are used in both preclinical and clinical drug development, and is developing companion patient care diagnostics focused on oncology, cardiovascular, inflammation and immune response genes. Source MDx OncoProfiling biomarker services for targeted cancer therapy development include the capture and enrichment of live Circulating Tumor Cells (CTCs) and Circulating Endothelial Cells (CECs) for off-line high-precision gene expression analysis with over 850 validated and patented targeted gene assays. The company has completed over 150 preclinical and clinical projects for more than 30 leading pharmaceutical, biotechnology and diagnostic companies, with over one million gene expression measurements analyzed.

About Tufts New England Medical Center

Tufts-New England Medical Center is a world-class academic medical institution that is home to both a full-service hospital for adults and the Floating Hospital for Children. Founded in 1796 as the Boston Dispensary to care for sick and needy Bostonians, Tufts-NEMC is the oldest health care facility in New England. The Medical Center is the principal teaching hospital for Tufts University School of Medicine. The Floating Hospital for Children, Tufts-NEMC's full-service children's hospital, began as a hospital ship more than a century ago. The 128-bed Floating Hospital provides comprehensive inpatient and outpatient services in every area of medical specialization.

Source MDx

CONTACT: Cristin Carr of Tufts-NEMC, +1-617-636-0200; or Michelle Linn ofSource MDx, +1-508 419-1555,

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