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Companion Diagnostics (CD) is a comparatively new field in IVD boosted by the enormous growth in genomic information over the past decade.Genomic information is increasingly being utilized for prior determination, if a therapy with monoclonal antibodies or small molecules is useful or not.The principle of CD has successfully been applied for many years, i.e.by the microscopic analysis of the estrogen receptor status in breast cancer prior to antiestrogen therapy or by sensitivity testing of pathogens (antibiogram).The therapeutic application of monoclonal antibodies such as Herceptin(R) began in the late 90ies and required the concomitant analysis of the HER2/NEU gene expression.New technologies, such as quantitative RT-PCR enabled us to supplement fluorescence-microscopic analyses with molecular genetics methods.CD as it is been defined today, mostly refers to acquired genetic alterations in tumors or pathogens, leading to drug resistance or escape phenomenons.In contrast to inborn germline conditions,CD involves moving targets such as the KRAS, EGFR, BRAF, PDGFR or the BCR/ABL fusion gene.A tumor continuously acquires somatic mutations in these genes by positive selection against the therapeutic agent.This requires multiple testing during the course of the disease.Since drug resistance or escape phenomenons usually involve several genes,parallel multiparametric testing by array technologies or Next Generation Sequencing will be applied in the very near future.