Method to predict or monitor the response of a patient to an ErbB receptor drug by screening for mutations in an ErbB receptor

摘要

Disclosed is an ex vivo method for predicting the response of a patient to an ErbB receptor drug comprising detecting one or more mutations in an ErbB receptor wherein said method comprises the steps of:- (a) providing a bio-fluid sample from a patient; (b) extracting DNA from said sample; (c) screening said DNA for the presence of one or more mutations in the receptor using PCR and one or more techniques selected from the group consisting of: Single Stranded Conformation Polymorphism (SSCP); Restriction Fragment Length Polymorphisms (RFLPs); WAVE; Real-time PCR, Amplification Refractory Mutation system (ARMS); and probes in combination with ARMS wherein said probes comprise a single-stranded bi-Iabelled fluorescent sequence held in a hairpin-loop conformation by complementary stem sequences on the 5' and 3' ends of the probe, further comprising a fluorescent reporter dye attached to the 5' end and a quencher molecule attached to the 3' end, and wherein the hairpin loop is linked to the 5' end of a primer via a PCR blocker; and (d) predicting the response of a patient to an ErbB receptor drug based on the presence or absence of a mutated allele encoding said ErbB receptor.