Who is Glycominds?
Glycominds holds extensive knowledge and experience in glycomics. Glycominds harnesses the development of unique glycan biomarkers for high-value medical diagnostics. Today, the company is developing and commercializing a new class of blood tests that enable physicians to detect diseases earlier, to predict autoimmune disease progression, and to decide on the therapy regimen.
What are the gMS® tests?
gMS® is a family of blood tests, which are tools for aiding the physician in diagnosing MS patients, and detecting patients with higher risk for severe disease progression. Glycominds offers diagnostic and prognostic tests that provide physicians with important information to better manage treatment for patients with Multiple Sclerosis.
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The gMS®Dx is a “rule in” test to be used as part of the diagnostic work-up of MS-suspected patients. A positive test greatly enhances the certainty that a patient has MS.
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The gMS®Pro EDSS blood test is a prognostic test that enables the physician to better stratify patients according to severity of disease.
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The gMS®Pro EDSS test is useful for patients at their first episode and for RRMS patients during the first decade of disease, thus enabling the detection of patients needing closer medical management.
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gMS®Dx
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gMS®Pro EDSS
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Patient Type
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· Suspected MS patients with typical MS symptoms and non-conclusive MRI
· MS symptoms that were not diagnosed with an alternative neurological disease
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· CIS patients
· RRMS patients on Disease Modifying Therapy (DMT) that you are considering switching to another DMT
· RRMS patients prior to their disability progression (EDSS3 and above)
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When?
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· Help provide a more accurate diagnosis when needed
· Commencing already from the first neurological event
· After first reported CIS
· After inconclusive diagnostic work-up
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· Naïve patients prior to starting DMT
· CIS patients at high risk to MS according to McDonald’s criteria
· At patient’s second relapse
· Newly diagnosed patients
· 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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Breakthrough, non-invasive, convenient blood test
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Marker Type
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· An MS specific biomarker (gMS classifier DX)
· Based on IgM antibodies against the a-glucose antigen GAGA4
· Normalized by total IgM
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· An MS specific biomarker (gMS classifier 1)
· Based on IgM antibodies against the a-glucose antigen GAGA2, GAGA3, GAGA4, GAGA6
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Test Performance
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Negative: LR- 0.53
Positive: LR+ 6.05
High Positive: LR+9.63
Overall: Specificity 92.8% Sensitivity 53.9%
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Risk for fast EDSS progression:
· Study 1: HR 2.05 (95%CI 1.2-3.5)
· Study 2: HR 6.9 (95%CI 2.0-23.4)
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Results
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Negative:
· Patient may still have MS or other neurological disease
· Continue with routine testing
Positive:
· Patient has a high likelihood of having MS
High Positive:
· Patient has a very high likelihood of having MS
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Negative:
· Patient has a low risk for fast disability progression as measured by EDSS
Positive:
· Patient has a high risk for fast disability progression as measured by EDSS
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Cost
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The cost is between the patient's healthcare insurance and the company - no pre-authorization is required - or patient self pay (full waive on patient deductible except Medicare/Medicaid)
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The cost is between the patient's healthcare insurance and the company - no pre-authorization is required - or patient self pay (full waive on patient deductible except Medicare/Medicaid)
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Patent
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US 7,537,900
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US 7,572,592
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How long have these tests been available? Why have I not heard of this?
The tests are relatively new, as they were launched in the US market in September 2010.
Are they CLIA approved?
The tests are performed by Glycominds Laboratory Services, which is a CLIA-certified laboratory operated in Simi Valley, California. CLIA License Number: 05D2010838.
Is this part of a clinical research study?
No. The tests are diagnostic tools to be used by physicians with blood samples collected from patients suspected of having MS.
How do I order this test?
To order the gMS ® tests, you only need to fill out a Test Requisition Form (TRF), sign on a statement of medical necessity, and fax it through to our 800 number. See more details on the Healthcare Professionals section - Ordering gMS® tests tab. |
