Blood IgM Anti-GAGA4 in the Diagnosis of Multiple Sclerosis (P03.240)

OBJECTIVE: To study the performance of gMSDx for diagnosis of multiple sclerosis (MS), in a prospective cohort of neurological patients, undergoing “real-life” diagnostics workup. BACKGROUND: Blood IgM anti -Glc(α-1,4)Glc(α) (anti -GAGA4) levels studied by a new test (gMSDx) seem to differentiate clinically isolated syndrome (CIS) / or relapsing remitting multiple sclerosis (RRMS) from other neurological diseases (OND). DESIGN/METHODS: 281 neurological patients were recruited and followed for at least 12 months. Clinical data and sera were collected at the beginning of the study. MS Diagnosis was defined by McDonald 2010 criteria. Frozen sera were analyzed for gMSDx (Glycominds, US). Patients were characterized using a previously defined cutoffs, as positive if >55, or high positive if >80 EU/(Total IgM mg/mL) 0.5. RESULTS: 136 patients (69% females) were diagnosed as MS, 9 remained as CIS or radiological isolated syndrome, 136 (55% females) were diagnosed as other neurological disease (OND). MS patients had significantly higher levels of IgM anti-GAGA4 normalized to total IgM than OND patients (p=0.004). 47/136 MS patients were positive vs. 26/136 OND (p= 0.009). Sensitivity, specificity, positive and negative likelihood ratios at cutoff>55EU/(Total IgM mg/mL) 0.5 were: 35%, 81%, 1.8 and 0.8; at cutoff>80EU/(Total IgM mg/mL) 0.5 were: 12.5%, 94%, 2.1 and 0.9. In the OND group, only 7/136 were high positive (95% specificity). CONCLUSIONS: This first prospective analysis of a “real life” consecutive cohort validates that gMSDx blood test discerns a subgroup of CIS/RRMS from OND. Supported by: Glycominds, Ltd. Disclosure: Dr. Villar has received personal compensation from Biogen Idec, Bayer Schering, and Merck Serono. Dr. Garcia-Caldentey has nothing to disclose. Dr. Costa-Frossard has received personal compensation for activities with Biogen Idec, Novartis, and Bayer Pharmaceuticals Corporation. Dr. Dotan has received personal compensation for activities with Glycominds Ltd. as an employee. Dr. Dotan holds stock and/or stock options in Glycominds Ltd., which sponsored research in which Dr. Dotan was involved as an investigator. Dr. Dukler has received personal compensation for activities with Glycominds as an employee. Dr. Dukler has received compensation for serving on the board of Glycominds. Dr. Dukler holds stock and/or stock options in Glycominds. Dr. Alvarez-Cermeno has nothing to disclose.