DioGenix Issued Seminal Patent for Diagnosing Early-stage Neurological Diseases

GAITHERSBURG, Md., March 18, 2013 /PRNewswire/ -- DioGenix, Inc. announced today that the United States Patent and Trademark Office has issued a patent that broadly protects DioGenix' proprietary next-generation sequencing assay, MSPrecise™, that has shown in recent clinical studies to accurately identify patients with multiple sclerosis (MS) at first clinical presentation.

"This patent, combined with DioGenix' expertise in developing novel molecular tests, is a strategic necessity, as our lead clinical trial advances to validate the accuracy of MSPrecise in real-world populations being evaluated for a variety of neuroimmune diseases like MS. These rights are merely the first in a growing patent estate based on novel insights into human neurology from a series of clinical studies initiated by the combined team at DioGenix and the University of Texas Southwestern Medical Center (UTSW)," said Larry Tiffany, President and CEO of DioGenix. "Indeed, this patent is a cornerstone of our intellectual property portfolio that allows the company to pursue a longer-term strategy; building a comprehensive pipeline of tests for a variety of immune-mediated neurological diseases."

U.S. Patent 8394583 entitled "VH4 Codon Signature for Multiple Sclerosis" claims and describes the use of DNA mutational analysis to profile the immune response of patients suspected of MS across a variety of biosamples (including cerebral spinal fluid and blood) and resulting biomolecules (DNA and RNA).  Specific "hot spots" are identified where the mutational frequency of DNA changes are more prevalent in patients with MS than in other similar neurological diseases and healthy controls.

"As we continue to immunoprofile patients that are difficult to discriminate given indefinite clinical symptoms, we believe that our patented approach will allow DioGenix to develop specific DNA mutational profiles for a host of immune-mediated neurological diseases," Mr. Tiffany continued.   

About MSPrecise
MSPrecise is based on the pioneering work of Dr. Nancy Monson of UTSW now utilizing next-generation sequencing to measure DNA mutations found in rearranged immunoglobin 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 specific 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.



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