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• W1603984609 abstract "OBJECTIVE: Multiple sclerosis is an autoimmune disorder of the CNS that is difficult to diagnose. The goal of this study is to validate a novel diagnostic assay to improve the early, accurate diagnosis of MS. BACKGROUND: The MSPrecise technology was developed based on research into novel patterns of B cell mutations in patients with MS. The study is ongoing, but has enrolled more than 80% of its cohort and preliminary data is available. DESIGN/METHODS: Cerebrospinal fluid (CSF) was collected from human subjects under a IRB-approved protocol. Each subject’s clinical data is evaluated by an adjudication Committee consisting of three practicing MS experts. CSF-derived cells were collected by centrifugation and stored frozen until use. Rearranged Ig heavy chain (IGH) V4(D)J gene segments were amplified from genomic DNA using a two-step PCR protocol based on the 4-primer Amplicon Tagging system (Fluidigm). Amplified and barcoded IGH-V4(D)J PCR amplicons were gel purified and used for Next Generation DNA Sequencing (NGS) using the 454 GS FLX+ Sequencing system and Titanium chemistry (Roche). Barcode sequences were used to identify sequence reads derived from each patient sample. MS Precise scores were then calculated using the remaining unique sequences according to the method of Cameron et al ( J Neuroimmunol . 2009 213:123-130). The MS Precise scores are used to classify patients using a cutoff of 6.8. RESULTS: More than 200 patients have been enrolled to date in the MS Precise Clinical Validation study. This study is ongoing and we project that more than 250 subjects will be enrolled in this by the end of 2013. Approximately 150 subjects have been adjudicated to date with 30% of the subjects receiving a unanimous (3 out of 3) consensus diagnosis of either RRMS or other neurological disease. The performance of MS Precise, based on current data, is 80% sensitive and 83% specific. CONCLUSIONS: MSPrecise represents a novel, biologically important diagnostic test for multiple sclerosis. Study Supported by: DioGenix Disclosure: Dr. Monsonhas received personal compensation from Genentech, Inc. and Medimmune. Dr. Monson has received research support from DioGenix, Inc. Dr. Eastman has received personal compensation for activities with Gene Logic, Inc., Versant Ventures, Calerome, Inc., Pain Therapeutics Inc., and Ritchie Capital Management. Dr. Bigwood has received personal compensation for activities with DioGenix, Inc. Dr. Levin has nothing to disclose. Dr. Rounds has nothing to disclose. Dr. Cowell has nothing to disclose. Dr. Greenberg has received personal compensation for activities with Chugai, GlaxoSmithKline, Inc., Sanofi-Aventis, Diogenix, Biogen Idec, Amplimmune, Acorda, and MSAA. Dr. Greenberg has received personal compensation in an editorial capacity for JAMA Neurology. Dr. Greenberg holds stock and/or stock options in DioGenix, Inc, which sponsored research in which Dr. Greenberg was involved as an investigator. Dr. Greenberg has received research support from Guthy-Jackson Charitable Foundation, Accelerated Cure Project, and Biogen Idec." @default.
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• W1603984609 date "2014-04-08" @default.
• W1603984609 modified "2023-09-23" @default.
• W1603984609 title "Update on MSPrecise: A Novel Diagnostic Test for Multiple Sclerosis (P4.138)" @default.
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