US2022074952A1PendingUtilityA1

Compositions and Methods to Detect Non-Coeliac Gluten Sensitivity

Assignee: LABORATORY CORP AMERICA HOLDINGSPriority: May 12, 2017Filed: Aug 19, 2021Published: Mar 10, 2022
Est. expiryMay 12, 2037(~10.8 yrs left)· nominal 20-yr term from priority
G01N 33/6893G01N 2800/065G01N 33/6869G01N 2333/54G01N 2333/5428G01N 33/6863G01N 2800/60G01N 2333/525G01N 2333/5421G01N 2800/06G01N 33/6854
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Claims

Abstract

Disclosed are compositions and methods to detect proteins associated with non-coeliac gluten sensitivity (NCGS). Such markers may be useful to allow individuals susceptible to NCGS to manage their food intake to avoid symptoms and further progression of disease.

Claims

exact text as granted — not AI-modified
That which is claimed is: 
     
         1 . A method of measuring biomarkers associated with non-coeliac gluten sensitivity (NCGS) in an individual suspected of having NCGS, comprising:
 obtaining a sample from the individual suspected of having NCGS; and   measuring in the sample obtained from the individual suspected of having NCGS an established statistical difference from a predetermined NCGS control value of an amount of at least one of: interleukin 8 (IL-8), an amount of total immunoglobulin E (IgE), an amount of IL-8 and IL-10, an amount of IL-8 and TNF-Alpha, an amount of IL-8 and total IgE, an amount of IL-10 and total IgE, or an amount of TNF-Alpha and total IgE, wherein the predetermined NCGS control value is an amount of at least one of IL-8, IL-10, TNF-Alpha, and total IgE found in individuals with no NCGS.   
     
     
         2 . The method of  claim 1 , wherein the measuring the established statistical difference comprises performing at least one immunoassay. 
     
     
         3 . The method of  claim 1 , further comprising measuring expression of at least one of interferon gamma-induced protein 10 (IP-10), CD4 or CD45 in the sample obtained from the individual suspected of having NCGS relative to control expression value in the individuals with no NCGS. 
     
     
         4 . The method of  claim 3 , wherein the measuring the expression comprises performing flow cytometry. 
     
     
         5 . The method of  claim 1 , wherein the sample comprises blood, serum, plasma or a tissue biopsy. 
     
     
         6 . A method of measuring biomarkers associated with non-coeliac gluten sensitivity (NCGS) in an individual suspected of having NCGS, comprising:
 obtaining a sample from the individual suspected of having NCGS; and,   measuring an established statistical difference from a predetermined NCGS control value of at least one of: expression of interleukin 8 (IL-8), expression of total immunoglobulin E (IgE), expression of IL-8 and IL-10, expression of IL-8 and TNF-Alpha, expression of IL-8 and total IgE, expression of IL-10 and total IgE, or expression of TNF-Alpha and total IgE,   wherein the predetermined NCGS control value is an expression of least one of IL-8, IL-10, TNF-alpha and total IgE found in individuals with no NCGS.   
     
     
         7 . The method of  claim 6 , wherein the measuring the established statistical difference comprises performing at least one immunoassay. 
     
     
         8 . The method of  claim 6 , wherein the measuring the established statistical difference comprises performing flow cytometry. 
     
     
         9 . The method of  claim 6 , further comprising measuring expression of at least one of interferon gamma-induced protein 10 (IP-10), CD4 or CD45 in the sample obtained from the individual suspected of having NCGS relative to control expression value in the individuals with no NCGS. 
     
     
         10 . The method of  claim 9 , wherein the measuring the expression comprises performing flow cytometry. 
     
     
         11 . The method of  claim 6 , wherein the sample comprises blood, serum, plasma or a tissue biopsy. 
     
     
         12 . A composition for measuring biomarkers associated with non-coeliac gluten sensitivity (NCGS) in an individual suspected of having NCGS, comprising reagents for measuring in the sample obtained from the individual suspected of having NCGS an established statistical difference from a predetermined NCGS control value of an amount or expression of at least one of: interleukin 8 (IL-8), an amount of total immunoglobulin E (IgE), an amount of IL-8 and IL-10, an amount of IL-8 and TNF-Alpha, an amount of IL-8 and total IgE, an amount of IL-10 and total IgE, or an amount of TNF-Alpha and total IgE,
 wherein the predetermined NCGS control value is an amount or expression of at least one of IL-8, IL-10, TNF-Alpha, and total IgE found in individuals with no NCGS.   
     
     
         13 . A kit comprising the composition of  claim 12 .

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