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Thursday, November 8, 2012

Company initiates trial to evaluate clinical performance of molecular diagnostic to identify patients that have, or are at risk of developing, multiple sclerosis


GAITHERSBURG, Md., Nov. 8, 2012 /PRNewswire/ -- DioGenix, Inc., a company developing molecular diagnostics for the early diagnosis and monitoring of immune-mediated neurological diseases, today announced its lead product MSPrecise™ outperformed the specificity of the current standard of care for cerebral spinal fluid (CSF) analysis in patients suspected of having multiple sclerosis (MS) by almost two to one with no loss of sensitivity. MSPrecise is a proprietary next-generation sequencing assay that analyzes changes in key genes involved in the adaptive immune system of patients being evaluated for MS. The results of this clinical study are consistent with two prior DioGenix studies, all of which compared MSPrecise results both to published performance data for the oligoclonal banding test and experimental controls.
Patients that present with clinical symptoms and evidence of inflammation and damage to the myelin sheath that surrounds and protects nerve fibers in the CNS undergo a battery of tests in a diagnostic process that can take months to years to complete. The diagnostic standard of care for MS includes CSF analysis using the oligoclonal banding test, which detects immunoglobin G proteins that indicate an immune response within the CNS. Because the oligoclonal banding test yields a high rate of false positive results, confident diagnosis also requires a comprehensive set of clinical tests including magnetic resonance imaging and, in certain cases, visual evoked potentials. Due to the variability of symptoms between patients and the lack of a definitive test, it has been estimated that the misdiagnosis rate for MS is higher than any other immune-mediated neurological disease.
"The results of our most recent study continue to support our belief that MSPrecise will be an important new tool in the management of patients suffering with MS. We have clearly demonstrated, in a series of clinical studies, the power of MSPrecise to accurately identify patients in the early stages of neurodegenerative disease," said Larry Tiffany, Chief Executive Officer, DioGenix, Inc. "We believe our deep sequencing approach has the potential to not only diagnose and classify patients with MS but eventually other immune-mediated neurological diseases as well."
In the recently completed study, DioGenix analyzed CSF samples that were retrospectively and prospectively collected from patients with MS and other neurological diseases, as well as healthy controls. CSF from two cohorts of approximately 40-45 patients each were compared; the first cohort included patients with a confirmed diagnosis of relapsing remitting MS, and the other cohort consisted of patients with other neurological diseases that mimic the presentation of MS and healthy controls. Subjects with MS had MSPrecise scores that were statistically significantly higher (p-value < 0.05) compared to both healthy controls and patients with other neurological diseases. The MSPrecise interpretive scoring system demonstrated a clear improvement in the ability to classify early-stage MS patients from those with other neurological diseases in comparison to published performance of oligoclonal banding tests.
"MSPrecise quantifies specific molecular changes in CSF-derived B cells and results generated to date indicate that it is more accurate than oligoclonal banding. The DioGenix assay bridges the divide between immunology research and bedside care using cutting-edge technology," said Dr. Michael Racke, Professor and Chairman of Neurology at The Ohio State University. "This represents an exciting advance in our efforts to more accurately diagnosis patients with multiple sclerosis and it is based on clinically relevant biomarkers of immune system response."
DioGenix has begun to validate these results in a prospective, multi-site clinical trial that has started enrolling approximately 150 subjects. This trial is designed to analyze subjects as they typically present to a neurologist and are being evaluated for a diagnosis of MS or other neurological disease. All subjects enrolled in this study will receive the current diagnostic standard of care in addition to analysis using MSPrecise


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