DioGenix and Fast Forward, LLC Collaborate to Develop Blood-Based Molecular Diagnostic for Multiple Sclerosis

GAITHERSBURG, Md., Nov. 8, 2012 /PRNewswire/ -- DioGenix, Inc. today announced an alliance with Fast Forward, a subsidiary of the National Multiple Sclerosis Society, to develop a novel blood test for multiple sclerosis (MS). Fast Forward will provide up to $500,000 as part of a Sponsored Research Agreement that will enable DioGenix to expand an ongoing clinical trial of its MS diagnostic, MSPrecise, a proprietary next-generation sequencing assay that measures changes to the adaptive immune system by analyzing B cells isolated from cerebral spinal fluid (CSF). This funding will allow DioGenix to determine if the same approach will work in blood samples.

The ability to now accurately identify early disease events affecting the adaptive immune system with next-generation sequencing provides a unique opportunity for an earlier diagnosis of MS and differentiation of disease subtypes. Validation of a DNA blood signature for MS is an important next step in DioGenix' plan to develop a neuro-immune panel that would distinguish other immune-mediated neurological diseases that share certain biological features with MS.

"We are pleased to partner with DioGenix in the advancement of this innovative technology for MS," said Timothy Coetzee, Ph.D., Chief Research Officer of the National MS Society. "Fast Forward's partnership with DioGenix reflects our commitment to develop new tools and technologies to assist physicians in making earlier and more confident diagnostic and treatment decisions for patients coping with neurological diseases, in particular with MS. We believe that these types of innovative programs are critical to improving the quality of life for people living with these diseases."

"Our collaboration with Fast Forward will allow us to more rapidly develop new tests that can have a profound impact on the lives of people living with MS. With this important funding, we can extend the utility of our already reliable CSF-based MSPrecise assay into blood, providing an additional option for the use of our test by clinicians as part of their routine work-up of patients who are struggling with non-specific neurological symptoms," said Larry Tiffany, Chief Executive Officer, DioGenix, Inc.

Dr. Larry Steinman, Professor of Neurology at Stanford University School of Medicine and a well-known innovator in neurological research commented, "Even with improving imaging capabilities we are still challenged to more specifically correlate MRI findings and symptoms to actual disease biology. B cells are integral to early disease mechanisms in MS and other neurological diseases. Technologies to elucidate immunoglobulin DNA rearrangement in the B cell genome involved in specific immune-mediated neurological diseases will be critical for understanding and treating patients."

MSPrecise uses next-generation sequencing to measure DNA mutations found in rearranged immunoglobin genes in B cells isolated from CSF. These mutations are a result of the adaptive immune system's response to a perceived challenge to the patient. The changes in the B cell DNA correspond to the production of diverse antibody libraries aimed at fighting the perceived foreign invader. It is believed that the specific mutational changes observed in patients with MS are different from those observed in patients with similar neurological diseases because the antigens recognized by the antibodies are different. MSPrecise would augment clinicians' current standard of care for diagnosis of MS, providing measurement of changes in B cell DNA as compared to the currently available test that merely measures the presence of immunoglobin G proteins in the CSF.

About Multiple Sclerosis

Multiple sclerosis is a chronic, unpredictable neurological disease that affects the central nervous system (CNS). It is thought to be an autoimmune disorder, meaning the immune system incorrectly attacks healthy tissue, in this case neurons, in the CNS. Symptoms may be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision. These problems may be permanent or may be relapsing and remitting. According to the National Multiple Sclerosis Society, at least 400,000 Americans have MS, and every hour someone is newly diagnosed.

About DioGenix, Inc.

DioGenix is developing novel molecular tests using application-specific, high-resolution state-of-the-art technologies that measure well-established human biology. With a focus in immune-mediated neurological diseases and disorders, DioGenix combines powerful insight into clinical diagnostic pathways with proprietary technology that results in earlier, more personalized intervention and treatment. The company's lead product, MSPrecise, is currently being evaluated in a trial to evaluate its clinical performance in identifying patients that have, or are at risk of developing multiple sclerosis. DioGenix is based Gaithersburg, MD. For additional information, please visit http://www.diogenix.com.

About Fast Forward, LLC

Fast Forward, LLC is a nonprofit organization established by the National Multiple Sclerosis Society in order to accelerate the development of treatments for MS. Fast Forward accomplishes its mission by connecting university-based MS research with private-sector drug development and by funding small biotechnology/pharmaceutical companies to develop innovative new MS therapies and repurpose FDA-approved drugs as new treatments for MS. More information can be found at www.fastforward.org.

About The National Multiple Sclerosis Society

The National MS Society addresses the challenges of each person affected by MS. To fulfill this mission, the Society funds cutting-edge research, drives change through advocacy, facilitates professional education, collaborates with MS organizations around the world, and provides programs and services designed to help people with MS and their families move forward with their lives. In2011 alone, through its national office and 50-state network of chapters, the Societydevoted $164 million to programs and services that assisted more than one million people. To move us closer to a world free of MS, the Society also invested $40 million to support more than 325 new and ongoing research projects around the world. The Society is dedicated to achieving a world free of MS. Join the movement at www.nationalMSsociety.org.

SOURCE DioGenix, Inc.