A major unmet need in MS is the absence of a simple, reproducible and inexpensive biomarker to determine the nature of the disease and monitor its progress. The gMS®Pro EDSS Test measures the level of IgM antibodies to a panel of glycan structures including GAGA2, 3, 4, 6. Several studies over 462 CIS and MS 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. Hazard ratio of 2.05 for CIS patients suggestive of MS and 10.5 for relapsing form of MS (Data on file at Glycominds Laboratory, CA License Number: CLF00340032).
Identifying the patient MS stage is important in order to administer the proper treatment.
The current standard of care for treatment of RRMS is:
- First line of Disease Modifying Therapies (DMT) such as beta-interferon (INFB 1a or INFB 1b) in MS and in Clinical Isolated Syndrome (CIS) suggestive of MS (i.e. high risk to convert to clinically definite MS)
- Glatiramer acetate in RRMS as soon as a patient is diagnosed with MS or CIS suggestive of MS (Goodin DS et al., 2002; Guideline Summary NGC-3144)
- Natalizumab (Tysabri) - a drug approved by the U.S. Food and Drug Administration (FDA) which improves measures of disease severity such as the EDSS progression rate and the T2-hyperintense and T1-hypointense lesion burden seen on magnetic resonance imaging (MRI) in patients with relapsing MS.
- More recently the FDA approved Fingolimod capsules (Gilenya) for the treatment of patients with relapsing form of MS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.