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 pow
|SOURCE DioGenix, Inc.|
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