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gMS® Tests Overview
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 the 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.
gMS®Pro EDSS Blood Test
The gMS ®Pro EDSS Test is a breakthrough tool to identify CIS patients and RRMS patients at risk for rapid disability progression. Using this blood test enables physicians to predict patients at risk for rapid EDSS progression, and therefore aids the neurologist in choosing the most appropriate treatment regimen. Thus, avoiding disease progression and accumulation of irreversible disability and lost of QOL.
The effect of MS progression is widely variable across patients. About 50% of patients reach the following disability milestones: loss of employment (10 years after diagnosis), need for assistive walking devices (15 years), and inability to walk (25 years). Additional impacts can include loss of arm function, loss of cognitive function, fatigue, weakness, pain, tremor, vision problems, urinary dysfunction, bowel dysfunction, muscle spasticity, swallowing disorders, sexual dysfunction, depression, anxiety, and others (AHRQ-Expert Commentaries December 8, 2008).
The gMS®Pro EDSS. Several studies on over 462 CIS and RRMS patients show that the level of antibodies to a panel of GAGA molecules under the classification rule called gMS-Classifier1, identifies MS patient at risk for rapid confirmed (irreversible) EDSS progression.
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Patient type
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CIS patients
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RRMS patients on Disease Modifying Therapy (DMT) that you are considering to switch to another DMT
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RRMS patient prior their disability progression (EDSS 3 and above)1
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When
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Naïve patients prior starting DMT
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CIS patients at high risk to MS according to McDonald’s criteria
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At patient’s second relapse
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Newly diagnosed patients
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When you consider switching to another DMT
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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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Panel of MS specific biomarkers based on IgM antibodies against the α-glucose anti (GAGA2, GAGA3, GAGA4, GAGA6), (gMS classifier 2)
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Test Performance
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Risk for fast EDSS progression:
Study 1: HR 2.05 (95%CI 1.2-3.5)2
Study 2: HR 6.9 (95%CI 2.0-23.4)3
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Interpretation of Results
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Positive: patient has a high risk to fast disability progression (as measured by EDSS)
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Negative: patient has a lower risk to fast disability progression (as measured by EDSS)
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The gMS-Classifier 1 serum assay (gMS®Pro EDSS) 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®Pro EDSS 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. |
