Biomarkers for multiple sclerosis
AssigneeGLX Analytix ApS
InventorsBrian William Della Valle, Casper Hempel, Marie Agnete Larsen
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Abstract
Described herein are biomarkers for the prediction of the risk of developing and/or having multiple sclerosis (MS), as well as staging/subtyping MS and methods for evaluating treatment protocols for MS and for assisting in the prognosis of MS. Also described herein are biomarkers associated with multiple sclerosis (MS), particular GLX molecules, and even more particular GLX-related glycosaminoglycans (GAGs) and GLX-related proteoglycans (PGs).
Claims39
A method for monitoring disease risk, progression, or regression of multiple sclerosis (MS) in a subject, the method comprising:
- detecting levels of at least two biomarkers in a first biological sample from a subject, wherein the subject is considered as having multiple sclerosis or at risk of developing multiple sclerosis, wherein the at least two biomarkers are glycocalyx (GLX)-related molecules, wherein detecting the levels of at least two biomarkers that are GLX-related in the first biological sample from the subject comprises detecting using at least one technique selected from the group consisting of:
- binding agents, immunoassays, antibody recognition, multiplexing, dot blotting, beads, microspheres, single-molecule array technology, mass spectrometry, HPLC, Raman spectroscopy, NIR spectroscopy, and NMR spectroscopy;
- comparing the levels of the at least two biomarkers in the first biological sample to at least one reference level for the at least two biomarkers, wherein the at least one reference level for the at least two biomarkers was determined using a statistical analysis of levels of the at least two biomarkers detected in at least one second biological sample, wherein the statistical analysis comprises at least one multivariate statistical test;
- and
- determining that the subject has a risk, a progression, or a regression of MS based at least in part on a result of the comparing of the levels of the at least two biomarkers in the first biological sample to the at least one reference level.
A method comprising:
- detecting a level of at least two GLX-related biomarkers in at least one first biological sample from at least one subject, wherein the detecting uses at least one technique selected from the group consisting of:
- binding agents, immunoassays, antibody recognition, multiplexing, dot blotting, beads, microspheres, single-molecule array technology, mass spectrometry, HPLC, Raman spectroscopy, NIR spectroscopy, and NMR spectroscopy;
- detecting the level of the at least two GLX-related biomarkers in at least one second biological sample from the subject, wherein said second biological sample has been obtained at a different time point than said at least one first biological sample from said at least one subject;
- and
- determining at least one cut-off level for the at least two GLX-related biomarkers using a multivariate statistical analysis wherein the at least one cut-off level indicates risk, progression, or regression of MS, wherein determining the at least one cut-off level using the multivariate statistical analysis comprises at least one multivariate statistical test.
A method for monitoring disease progression or regression of multiple sclerosis (MS) in a subject, the method comprising:
- detecting levels of at least two biomarkers in a first biological sample from a subject, wherein the subject is considered as having multiple sclerosis or at risk of developing multiple sclerosis, wherein the at least two biomarkers comprise GLX-related biomarkers, wherein detecting a level in the first biological sample of one or more biomarkers of the at least two biomarkers comprises using at least one technique selected from the group consisting of:
- binding agents, immunoassays, antibody recognition, multiplexing, dot blotting, beads, microspheres, single-molecule array technology, mass spectrometry, HPLC, Raman spectroscopy, NIR spectroscopy, and NMR spectroscopy;
- detecting the levels of the at least two biomarkers in a second biological sample from the subject, wherein said second biological sample has been obtained at a different time point than said first biological sample from said subject;
- comparing the levels of the at least two biomarkers detected in the first biological sample and/or the second biological sample from the subject to at least one reference level determined using a multivariate statistical analysis of levels of the at least two biomarkers detected in at least one other biological sample, wherein the multivariate statistical analysis comprises at least one multivariate statistical test;
- and
- determining that the subject has a risk, a progression or a regression of MS based at least in part on a result of the comparing of the levels of the at least two biomarkers in the first biological sample and/or the second biological sample to the at least one reference level.
A method comprising:
- evaluating a biological sample from a subject for indications of glycocalyx (GLX) shedding in the subject, wherein evaluating the biological sample for indications of presence of glycocalyx shedding comprises detecting levels of at least two GLX-related molecules in the biological sample, wherein the detecting a level of one or more GLX-related molecules, of the at least two GLX-related molecules, comprises using at least one technique selected from the group consisting of:
- binding agents, immunoassays, antibody recognition, multiplexing, dot blotting, beads, microspheres, single-molecule array technology, mass spectrometry, HPLC, Raman spectroscopy, NIR spectroscopy, and NMR spectroscopy;
- determining a risk of the subject for multiple sclerosis (MS) based on whether the biological sample shows indications of GLX shedding, wherein determining the risk of the subject comprises comparing the levels in the biological sample of the at least two GLX-related molecules to respective reference levels for the at least two GLX-related molecules, wherein the respective reference levels for one or more of the at least two GLX-related molecules were determined using at least one multivariate statistical test;
- and
- outputting the risk of the subject for MS.
At least one computer-readable storage medium having encoded thereon executable instructions that, when executed by at least one processor, cause the at least one processor to carry out a method, the method comprising:
- evaluating a biological sample from a subject for indications of glycocalyx (GLX) shedding in the subject, wherein evaluating the biological sample for indications of presence of glycocalyx shedding comprises detecting levels of at least two GLX-related molecules in the biological sample;
- determining a risk of the subject for multiple sclerosis (MS) based on whether the biological sample shows indications of GLX shedding, wherein determining the risk of the subject comprises comparing the levels in the biological sample of the at least two GLX-related molecules to respective reference levels for the at least two GLX-related molecules;
- and
- outputting the risk of the subject for MS.
An apparatus comprising:
- at least one processor;
- and
- at least one storage medium having encoded thereon executable instructions that, when executed by the at least one processor, cause the at least one processor to carry out a method, the method comprising:
- evaluating a biological sample from a subject for indications of glycocalyx (GLX) shedding in the subject, wherein evaluating the biological sample for indications of presence of glycocalyx shedding comprises detecting levels of at least two GLX-related molecules in the biological sample;
- determining a risk of the subject for multiple sclerosis (MS) based on whether the biological sample shows indications of GLX shedding, wherein determining the risk of the subject comprises comparing the levels in the biological sample of the at least two GLX-related molecules to respective reference levels for the at least two GLX-related molecules;
- and
- outputting the risk of the subject for MS.
Dependencies are inferred from the claim text.