Biomarkers

Abstract

The invention relates to biomarkers and a method of diagnosing or monitoring depression, anxiety disorder or other psychotic disorder.

1 - 21 . (canceled) 
     
     
         22 . A method comprising:
 (a) obtaining a biological sample from an individual and quantifying the amounts of biomarkers in the biological sample, wherein the biomarkers comprise at least two biomarkers selected from the group consisting of Interleukin 10 (IL-10), Interleukin 18 (IL-18), Interleukin 2 (IL-2), Interleukin 8 (IL-8), Monocyte Chemotactic Protein 1 (MCP-1), Macrophage Inflammatory Protein 1 alpha (MIP-1α), Macrophage Inflammatory Protein 1 beta (MIP-1β) Matrix Metalloproteinase 2 (MMP-2), Tumor Necrosis Factor beta (TNF-β), Interleukin 4 (IL-4), and Interferon gamma (IFN-γ); and   (b) quantifying the amounts of the biomarkers in a control population to generate a reference standard wherein the control population comprises normal subjects;   wherein the quantifying is performed by measuring the concentration of the analyte biomarkers by one or more methods selected from SELDI (-TOF), MALDI (-TOF), a 1-D gel-based analysis, a 2-D gel-based analysis, Mass spec (MS), reverse phase (RP) LC, size permeation (gel filtration), ion exchange, affinity, HPLC, UPLC or other LC or LC-MS-based technique, by an immunological method, or by a biosensor or a microanalytical, microengineered, microseparation or immunochromatography system.   
     
     
         23 . The method of  claim 22 , wherein the biomarkers further comprise one or more biomarkers selected from the group consisting of C-reactive protein (CRP), Interleukin 6 (IL-6) and Tumor Necrosis Factor alpha (TNF-α). 
     
     
         24 . The method of  claim 22 , wherein the biomarkers comprise Interleukin 10 (IL-10), Interleukin 18 (IL-18), Interleukin 2 (IL-2), Interleukin 8 (IL-8), Monocyte Chemotactic Protein 1 (MCP-1), Macrophage Inflammatory Protein 1 alpha (MIP-1α), Macrophage Inflammatory Protein 1 beta (MIP-1β), Matrix Metalloproteinase 2 (MMP-2), Tumor Necrosis Factor beta (TNF-β), Interleukin 4 (IL-4), Interferon gamma (IFN-γ), Interleukin 6 (IL-6) and Tumor Necrosis Factor alpha (TNF-α). 
     
     
         25 . The method of  claim 24 , wherein the biomarkers further comprise C-reactive protein (CRP). 
     
     
         26 . The method of  claim 22 , wherein the biomarkers are quantified in samples taken on two or more occasions from the individual. 
     
     
         27 . The method of  claim 26 , wherein one of the two or more occasions is prior to commencement of therapy and one of the two or more occasions is after commencement of therapy. 
     
     
         28 . The method of  claim 22 , wherein the biological sample comprises cerebrospinal fluid, whole blood, blood serum, plasma, urine, saliva, a bodily fluid, breath, or condensed breath, or an extract or purification therefrom, or a dilution thereof. 
     
     
         29 . The method of  claim 22 , wherein the individual has not been diagnosed with depression or anxiety disorder. 
     
     
         30 . The method of  claim 22 , wherein the individual has been diagnosed with depression or anxiety disorder. 
     
     
         31 . A method comprising:
 (a) obtaining a biological sample from an individual and quantifying the amounts of biomarkers in the biological sample, wherein the biomarkers comprise at least two biomarkers selected from the group consisting of Interleukin 10 (IL-10), Interleukin 18 (IL-18), Interleukin 2 (IL-2), Interleukin 8 (IL-8), Monocyte Chemotactic Protein 1 (MCP-1), Macrophage Inflammatory Protein 1 alpha (MIP-1α), Macrophage Inflammatory Protein 1 beta (MIP-1β), Matrix Metalloproteinase 2 (MMP-2), Tumor Necrosis Factor beta (TNF-β), Interleukin 4 (IL-4), and Interferon gamma (IFN-γ); and   (b) comparing the amounts of the biomarkers in the biological sample with the amounts of the biomarkers present in a reference standard.   
     
     
         32 . The method of  claim 31 , wherein the quantifying is performed by measuring the concentration of the analyte biomarkers by one or more methods selected from SELDI (-TOF), MALDI (-TOF), a 1-D gel-based analysis, a 2-D gel-based analysis, Mass spec (MS), reverse phase (RP) LC, size permeation (gel filtration), ion exchange, affinity, HPLC, UPLC or other LC or LC-MS-based technique, by an immunological method, or by a biosensor or a microanalytical, microengineered, microseparation or immunochromatography system. 
     
     
         33 . The method of  claim 31 , wherein the biomarkers further comprise one or more biomarkers selected from the group consisting of C-reactive protein (CRP), Interleukin 6 (IL-6) and Tumor Necrosis Factor alpha (TNF-α). 
     
     
         34 . The method of  claim 31 , wherein the biomarkers comprise Interleukin 10 (IL-10), Interleukin 18 (IL-18), Interleukin 2 (IL-2), Interleukin 8 (IL-8), Monocyte Chemotactic Protein 1 (MCP-1), Macrophage Inflammatory Protein 1 alpha (MIP-1α), Macrophage Inflammatory Protein 1 beta (MIP-1β), Matrix Metalloproteinase 2 (MMP-2), Tumor Necrosis Factor beta (TNF-β), Interleukin 4 (IL-4), Interferon gamma (IFN-γ), Interleukin 6 (IL-6) and Tumor Necrosis Factor alpha (TNF-α). 
     
     
         35 . The method of  claim 34 , wherein the biomarkers further comprise C-reactive protein (CRP). 
     
     
         36 . The method of  claim 31 , wherein the biological sample comprises cerebrospinal fluid, whole blood, blood serum, plasma, urine, saliva, a bodily fluid, breath, or condensed breath, or an extract or purification therefrom, or a dilution thereof. 
     
     
         37 . The method of  claim 31 , wherein the reference standard is obtained from a control population comprising normal subjects. 
     
     
         38 . The method of  claim 31 , wherein the reference standard is obtained from a control population comprising subjects who have previously been diagnosed with depression and/or anxiety. 
     
     
         39 . A kit, comprising at least two ligands specific for at least two biomarkers selected from the group consisting of Interleukin 10 (IL-10), Interleukin 18 (IL-18), Interleukin 2 (IL-2), Interleukin 8 (IL-8), Monocyte Chemotactic Protein 1 (MCP-1), Macrophage Inflammatory Protein 1 alpha (MIP-1α), Macrophage Inflammatory Protein 1 beta (MIP-1β), Matrix Metalloproteinase 2 (MMP-2), Tumor Necrosis Factor beta (TNF-β), Interleukin 4 (IL-4), Interferon gamma (IFN-γ), Interleukin 6 (IL-6) and Tumor Necrosis Factor alpha (TNF-α). 
     
     
         40 . The kit of  claim 39 , wherein the at least two biomarkers are selected from the group consisting of Interleukin 10 (IL-10), Interleukin 18 (IL-18), Interleukin 2 (IL-2), Interleukin 8 (IL-8), Monocyte Chemotactic Protein 1 (MCP-1), Macrophage Inflammatory Protein 1 alpha (MIP-1α), Macrophage Inflammatory Protein 1 beta (MIP-1β), Matrix Metalloproteinase 2 (MMP-2), Tumor Necrosis Factor beta (TNF-β), Interleukin 4 (IL-4), Interferon gamma (IFN-γ), Interleukin 6 (IL-6), Tumor Necrosis Factor alpha (TNF-α) and C-reactive protein (CRP). 
     
     
         41 . The kit of  claim 39 , further comprising a control,
 a reagent, and   a consumable.