DioGenix Raises $3.2 Million for Novel Molecular Diagnostic for Multiple Sclerosis, MSPrecise

GAITHERSBURG, Md., Dec. 5, 2013 /PRNewswire/ -- DioGenix, Inc. announced today that it raised $3.2 million in a private financing consisting of new individual investors and returning investors including life sciences fund Nerveda, LLC. The financing follows recent interim results from a prospective clinical trial of DioGenix' MSPrecise®, a next-generation sequencing assay, which continues to show that it can accurately identify patients with multiple sclerosis (MS) at first clinical presentation.

The financing will support the completion of the largest prospective clinical diagnostic trial of its kind in MS.  This study should validate the performance of MSPrecise in a population of patients being evaluated for MS and a variety of other neurological diseases. DioGenix has also established a new central laboratory that will serve as the basis for the company's future commercialization of MSPrecise upon CLIA licensure.

DioGenix also announced that it has expanded its licensing arrangement with the University of Texas Southwestern Medical Center (UTSW) to provide exclusivity to core technology related to MSPrecise for MS and other neurological diseases.

"DioGenix exemplifies an ideal investment for Nerveda, as MSPrecise could significantly improve upon existing methods for diagnosing multiple sclerosis and other neurological diseases. DioGenix has achieved important development and business milestones that pave the way for its lead product to achieve additional clinical progress in 2014," said Cam Gallagher, Chairman of DioGenix and President of Nerveda, a private life science fund.

"Our new and long-term investors appreciate the value proposition of MSPrecise – to give physicians superior tools and insights when they are evaluating patients with neurological dysfunction at first clinical presentation. With the growing portfolio of therapeutics now available for MS, it is critical that we achieve similar innovations in our diagnostic methods to ensure patients obtain early and appropriate interventions," said Larry Tiffany, President and CEO of DioGenix.

Patients that present with clinical symptoms and evidence of non-specific neurological disease undergo a battery of tests in a diagnostic process that can take months or even years to complete. The diagnostic standard of care for MS includes cerebral spinal fluid analysis using the oligoclonal banding test alongside a comprehensive set of clinical tests to rule-out other neurological diseases. Unfortunately, the oligoclonal banding test yields a high rate of false positive results, which can unnecessarily expose patients who do not have MS to chronic and expensive therapy that, in some cases, actually exacerbates their underlying disease. Alternatively, false negatives can delay the proper treatment of those patients who do have MS, possibly accelerating the development of permanent physical disability.

In previous studies, MSPrecise outperformed the specificity of the current standard of care for cerebral spinal fluid analysis in patients suspected of having MS by almost two to one with no loss of sensitivity. The current prospective, blinded, multi-site trial is designed to further validate DioGenix' deep-sequencing approach.

About MSPrecise®

MSPrecise utilizes next-generation sequencing to measure DNA mutations found in rearranged immunoglobulin genes in immune cells initially isolated from cerebrospinal fluid. MSPrecise would augment the current standard of care for the diagnosis of MS by providing a more accurate measurement of a patient's immune response to a challenge within the central nervous system. This novel method of measuring changes in adaptive human immunity may also be able to discern individuals whose disease is more progressive and requires more aggressive treatment.

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 prospective 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.

SOURCE DioGenix, Inc.