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Abstract Details

Application of a Novel Diagnostic Test to Patients with Demyelinating Disease: The Accuracy of MSPrecise TM
MS and Related Diseases
P03 - (-)
242
BACKGROUND: With the development of many new effective therapeutic options, diagnosing multiple sclerosis early and accurately has become a priority for healthcare providers and patients. We have recently demonstrated that B cells from the cerebrospinal fluid of patients diagnosed with Multiple Sclerosis (MS) have a distinct pattern of somatic hypermutation in their antibody genes that is shared with CIS patients who develop MS in the future.
DESIGN/METHODS: Patients with MS, transverse myelitis and optic neuritis undergoing lumbar puncture as part of their clinical care were consented to take part in an IRB approved biorepository effort. Deidentified samples were used to isolate DNA from B cells and determine their rate of somatic hypermutation.
RESULTS: Using this approach, we have tested over 100 subjects in a two-stage independent study. In the most recent stage, MSPreciseTM classified RRMS with 100% specificity and an overall accuracy of 84%, based on the mutational frequency in their B cell antibody repertoires. We are in the process of recruiting 150 new subjects into a blinded, prospective multi-site clinical trial to validate these findings. As part of our analysis we will analyze each patient's blood alongside their CSF. Since we will be collecting biosamples from these patients prior to their definitive diagnosis we will compare the results from MSPreciseTM with the consensus diagnosis from from a clinical adjudication panel.
CONCLUSIONS: Beyond advancing diagnostic evaluations, these mutation patterns will be potentially helpful for understanding the pathogenesis of multiple sclerosis.
Authors/Disclosures
Nancy Monson (University of Texas Southwestern)
PRESENTER 		Nancy Monson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech, Inc.. Nancy Monson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for GenrAb, Inc.. Nancy Monson has stock in GenrAb, Inc.. The institution of Nancy Monson has received research support from NIH. Nancy Monson has received intellectual property interests from a discovery or technology relating to health care.
Ann Ligocki No disclosure on file
No disclosure on file
Douglas Bigwood (DioGenix) No disclosure on file
Eric M. Eastman, PhD (DioGenix, Inc.) No disclosure on file
No disclosure on file
Elliot M. Frohman, MD, FAAN Dr. Frohman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Janssen. Dr. Frohman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Janssen. Dr. Frohman has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Up To Date. Dr. Frohman has received publishing royalties from a publication relating to health care.
Eric M. McDade, DO (Washington University At St. Louis School of Medicine) Dr. McDade has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. McDade has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. McDade has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alector. Dr. McDade has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alzamend. Dr. McDade has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alnylam. Dr. McDade has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ionis. Dr. McDade has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche-Genentech. The institution of Dr. McDade has received research support from NIA. The institution of Dr. McDade has received research support from Eli Lilly. The institution of Dr. McDade has received research support from Hoffman-La Roche. The institution of Dr. McDade has received research support from Eisai. The institution of Dr. McDade has received research support from Eisai. Dr. McDade has received intellectual property interests from a discovery or technology relating to health care. Dr. McDade has received personal compensation in the range of $500-$4,999 for serving as a Advisory Board Member with Fondation Alzheimer.
Benjamin M. Greenberg, MD, FAAN (UT Southwestern Medical Center) Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Greenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Greenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Greenberg has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Sanofi/Genzyme. Dr. Greenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech/Roche. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Signant. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for IQVIA. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Greenberg has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Clene. Dr. Greenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for IQVIA. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abcuro. Dr. Greenberg has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Siegel Rare Neuroimmune Association. Dr. Greenberg has or had stock in GenrAb.Dr. Greenberg has or had stock in Clene.Dr. Greenberg has received intellectual property interests from a discovery or technology relating to health care. Dr. Greenberg has received publishing royalties from a publication relating to health care.