Method for Identifying an Agent for Treating Abnormal Kidney Function

Abstract

Biomarkers for pre-Diabetes, Diabetes and/or a Diabetes related conditions, and methods of their use, including the biomarkers in Tables 1 and 2 such as peroxiredoxin-2, complement C1q subcomponent subunit B, sulfhydryl oxidase 1 and apolipoprotein A-IV.

1 - 42 . (canceled) 
     
     
         43 . A biomarker selected from the list of biomarkers in Table 1 or 2. 
     
     
         44 . A method of assessing a subject for pre-Diabetes, Diabetes and/or a Diabetes related condition comprising measuring at least one biomarker in a sample from the subject, wherein said at least one biomarker is selected from the list of biomarkers in Table 1 or 2. 
     
     
         45 . A method according to  claim 44 , wherein the at least one biomarker CD5 antigen like and one, two, three, or four of the other biomarkers in Table 1 or 2. 
     
     
         46 . A method of assessing a subject for pre-Diabetes, Diabetes and/or a Diabetes related condition comprising measuring at least one biomarker in a sample from the subject, wherein said at least one biomarker is
 a) CD5 antigen like, Peroxiredoxin-2, Complement C1q subcomponent subunit B, Sulfhydryl oxidase 1 or Apolipoprotein A-IV;   b) one or more of CD5 antigen like, Peroxiredoxin-2, Protein AMBP and Complement C1q subcomponent;   c) one or more of CD5 antigen like, Complement C1q subcomponent subunit B, Protein AMBP, Adiponectin and Complement Factor H-related protein 2; or   d) CD5 antigen like, Peroxiredoxin-2, Protein AMBP and Complement C1q subcomponent subunit B.   
     
     
         47 . A method according to  claim 44 , wherein the step of measuring at least one biomarker in a sample from the subject comprises the use of mass spectrometry. 
     
     
         48 . A method according to  claim 47 , wherein the mass spectrometry comprises measuring a peptide of the at least one biomarker. 
     
     
         49 . A method according to  claim 48 , wherein the peptide is selected from the list of:
 (i) a 10-15 amino acid peptide of a protein from Table 1 or 2;   (ii) a 5-25 amino acid peptide of a protein from Table 1 or 2;   (iii) a 5-20 amino acid peptide of a protein from Table 1 or 2;   (iv) a 10-20 amino acid peptide of a protein from Table 1 or 2; or   (v) a peptide in Table 3.   
     
     
         50 . A method according to  claim 47 , wherein the mass spectrometry comprises multiple reaction monitoring (MRM) mass spectrometry. 
     
     
         51 . The method according to  claim 44 , wherein the sample comprises a blood sample. 
     
     
         52 . A kit comprising reagents for measuring at least one biomarker in a sample from a subject, wherein said at least one biomarker according to  claim 43 . 
     
     
         53 . The kit of  claim 52 , wherein at least one of the reagents comprises a detectable label. 
     
     
         54 . A method of assessing a treatment for pre-Diabetes, Diabetes and/or a Diabetes related condition in a subject comprising measuring at least one biomarker according to  claim 43  in a sample from the subject undergoing the treatment at least twice over the course of the treatment. 
     
     
         55 . A method of monitoring pre-Diabetes, Diabetes and/or a Diabetes related condition in a subject comprising measuring at least one biomarker according to  claim 43  in a sample from the subject and comparing the measurement obtained with another measure of the at least one biomarker. 
     
     
         56 . A method of diagnosing or identifying pre-Diabetes, Diabetes and/or a Diabetes related condition in a subject comprising measuring at least one biomarker according to  claim 43 . 
     
     
         57 . A test system comprising:
 (i) means for obtaining test results data representing levels of at least one biomarker according to  claim 43  in a sample from the subject;   (ii) means for collecting and tracking the test results data generated in step (i);   (iii) means for calculating a pre-Diabetes, Diabetes and/or a Diabetes related condition risk index value from the test results data, wherein said risk index value is representative of the risk of an individual developing or having pre-Diabetes, Diabetes and/or a Diabetes related condition; and   (iv) means for reporting said risk index value.   
     
     
         58 . A method of diagnosing or identifying a subject with pre-Diabetes, Diabetes and/or a Diabetes related condition comprising measuring at least one biomarker according to  claim 43  in a sample from the subject. 
     
     
         59 . A method of monitoring pre-Diabetes, Diabetes and/or a Diabetes related condition therapy or intervention comprising measuring at least one biomarker according to  claim 43  in a sample from the subject. 
     
     
         60 . A method of identifying or assessing an agent for treating or reducing the risk of developing pre-Diabetes, Diabetes and/or a Diabetes related condition comprising:
 (i) contacting cells expressing at least one biomarker according to  claim 43  with a putative agent; and   (ii) comparing expression and/or levels of the at least one biomarker in the cells prior to contact with the putative agent to expression and/or levels of the at least one biomarker after contact with the putative agent;   
       wherein a change in the level or expression identifies the agent as an agent for treating pre-Diabetes, Diabetes and/or a Diabetes related condition.