Methods and compositions for the assessment of drug response

Abstract

The present invention provides methods for predicting or determining a subject's response to an antiplatelet agent, and methods for determining a subject's suitability to a treatment regime or intervention for a disease associated with platelet aggregation, using analysis of genetic polymorphisms. The present invention also relates to the use of genetic polymorphisms in assessing a subject's response to an antiplatelet agent. Nucleotide probes and primers, kits, and microarrays suitable for such assessment are also provided

We claim: 
     
         1 . A method of scoring a subject's response to clopidogrel comprising:
 i) detecting the presence of the −806C/T polymorphism in the CYP2C19 gene (CYP2C19*17) in a sample from said subject and determining that said subject is homozygous for said CYP2C19*17 polymorphism;   ii) detecting the presence of a 636 G>A polymorphism (CYP2C19*3) and/or the presence of a 19154G/A polymorphism (CYP2C19*2) in said sample from said subject;   iii) determining a clopidogrel response score for said subject.   
     
     
         2 . A system for testing a subject's response to clopidogrel, comprising:
 a) an assay configured to analyze a sample from the subject for the presence of one or more resistance polymorphisms in the CYP2C19 gene and generate an analysis result;   b) a computer processor means configured to receive, process, and communicate data;   c) a reference database of results of at least one genetic analysis of the one or more resistance polymorphisms in the CYP2C19 gene with respect to response to clopidogrel; and   d) a software means configured to process the analysis result in the context of the reference database.   
     
     
         3 . A method comprising:
 a) analyzing a sample from a subject with a SNP detection assay to determine that said subject is homozygous for one or more polymorphisms in the CYP2C19 gene, thereby generating a homozygous genetic analysis result;   b) inputting said homozygous genetic analysis result into a system, where said system comprises:
 i) a computer processor for receiving, processing, and communicating data, 
 ii) a storage component for storing data which contains a reference genetic database of results of at least one genetic analysis of homozygosity with respect to response to clopidogrel, and 
 iii) a computer program, embedded within said computer processor, which is configured to process said homozygous genetic analysis result in the context of said reference database to determine, as an outcome, said subject's response to clopidogrel; 
   c) processing said homozygous genetic analysis result with said computer program in the context of said reference database to determine, as an outcome, said subject's response to clopidogrel; and   d) communicating said outcome from said computer program.