Methods and compositions for predicting drug responses

Abstract

The present invention relates to methods and compositions for predicting drug responses. In particular, the present invention provides methods and compositions for determining individualized Warfarin dosages based on the level of expression of the VKORC1 gene.

1 . A method, comprising: providing a sample from a subject; and determining said subject's VKORC1 expression level to determine responsiveness to Warfarin therapy.  
     
     
         2 . The method of  claim 1 , further comprising the step of determining said subject's optimal Warfarin dose based on said subject's VKORC1 expression level.  
     
     
         3 . The method of  claim 1 , further comprising the step of determining said subject's CYP2C9 genotype.  
     
     
         4 . The method of  claim 1 , wherein said determining said subject's VKORC1 expression level comprises determining the amount of VKORC1 mRNA expressed by said subject.  
     
     
         5 . The method of  claim 4 , wherein said determining the amount of VKORC1 mRNA expressed by said subject comprises a quantitative RT-PCR assay.  
     
     
         6 . The method of  claim 4 , wherein said determining the amount of VKORC1 mRNA expressed by said subject comprises a nucleic acid hybridization assay.  
     
     
         7 . The method of  claim 1 , wherein said determining said subject's VKORC1 expression level comprises determining the amount of VKORC1 polypeptide expressed by said subject.  
     
     
         8 . The method of  claim 7 , wherein said determining the amount of VKORC1 polypeptide expressed by said subject comprises exposing said sample to an antibody that specifically binds to said VKORC1 polypeptide.  
     
     
         9 . A kit for determining a subject optimal Warfarin dosage, comprising: 
 a) reagents for performing a detection assay, wherein said detection assay is configured to specifically detect said subject's VKORC1 expression level; and    b) instructions for determining said subject's optimal Warfarin dosage.    
     
     
         10 . The kit of  claim 9 , wherein said reagents comprise reagents for determining the amount of VKORC1 mRNA expressed by said subject.  
     
     
         11 . The kit of  claim 10 , wherein said reagents comprise reagents for performing a quantitative RT-PCR assay.  
     
     
         12 . The kit of  claim 10 , wherein said reagents comprise reagents for performing a nucleic acid hybridization assay.  
     
     
         13 . The kit of  claim 9 , wherein said reagents comprise reagents for determining the amount of VKORC1 polypeptide expressed by said subject.  
     
     
         14 . The kit of  claim 13 , wherein said reagents comprise an antibody that specifically binds to said VKORC1 polypeptide.  
     
     
         15 . The kit of  claim 9 , further comprising reagents for determining said subject's CYP2C9 genotype.