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The gMS® Tests are performed exclusively by Glycominds Laboratory Services at our CLIA approved lab in Simi Valley, California (CA License Number: CLF00340032).
gMS®Dx Blood Test
The gMS®Dx blood test is a breakthrough tool which was designed as a companion to magnetic resonance imaging (MRI) scan in order to expedite the diagnosis of RRMS in suspected MS cases with nonspecific MS symptoms and typical CIS patients. The gMS®Dx test enables early treatment as required by the American Academy of Neurology (AAN) Guidelines, while replacing repeated MRI scans and avoidance of additional diagnostic office visits and tests.
The gMS®Dx MS blood test is based on the measurement of IgM antibodies to the glycan structure GAGA4 and normalized by total IgM levels. The gMS®Dx assay is the first validated serum based test for MS. The blood test is highly specific to rule-in RRMS patients at the first neurological event. Over 1,352 MS patients, healthy controls and patients with other neurological disorders that mimic MS were screened by the gMS®Dx test. Findings show that when using the gMS®Dx test once, at the first neurological presentation, it is able to identify RRMS patients with high specificity. As a companion tool to MRI, cut-off values were set at high specificity to yield mid-level sensitivity. Therefore, it is not recommended to replace baseline MRI scans, but to decrease the number of repeated MRI scans after baseline.
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Patient Type
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Suspected MS patient with typical MS symptoms and non-conclusive MRI
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Suspected MS patient with nonspecific or atypical MS symptoms that was not diagnosed with other neurological
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When
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Help provide a more accurate diagnosis when needed
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Commencing already from the first neurological event
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Suited after first reported CIS
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After inconclusive diagnostic work-up
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Test Type
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Breakthrough, non invasive, convenient blood test
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Marker Type
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An MS specific biomarker (gMS classifier Dx)
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Based on IgM antibodies against the α-glucose antigen GAGA4
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Normalized by total IgM
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Test Performance
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Negative: LR- 0.53
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Positive: LR+ 6.05
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High Positive: LR+ 9.6
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Overall: Specificity 92.8%, Sensitivity 53.9%
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Negative: Patient may still have MS or other neurological disease
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Continue with routine testing
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Positive: Patient has a high likelihood of having MS
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High Positive: Patient has a very high likelihood of having MS
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The gMS-Classifier Dx serum assay (gMS®Dx) is a laboratory developed test. The performance characteristics were determined by Glycominds, Inc. glycominds, Inc.s' Clinical Laboratory is regulated under Clinical Laboratory Improvement Amendments of 1988 (CLIA) and qualified to perform high-complexity clinical testing. The gMS®Dx test should be used solely for clinical purposes. It should not be regarded as investigational or for research. Physicians should use this results in conjunction with other patient clinical information. The US food and Drug Administration has not reviewed or approved this test. |
