Genomic classification of patients likely to benefit from new drugs
Clinical trial participants can be segmented based on genomic profiles and observed therapeutic response to discover potential biomarkers, or confirm their clinical validity. Participants can be screened using specific panels of genes and variants as well as entire exomes or genomes, to identify patients with a specific genomic signature. Panels can screen participants based on pharmacogenomic activity, and genes up- or down-regulated by existing drugs can be analyzed. In addition, genomic profiles can be correlated with gene expression data to understand pathways and confirm the genetic basis of gene expression.
Development of validated assays for genomic classification
The success of Genentech’s HER2 diagnostics and Trastuzumab has generated interest in co-developing drugs and companion diagnostics. Genomic biomarkers within a trial cohort can be identified, targeted, and screened for as part of the development of diagnostic assays.
Design of more focused trials to test efficacy of new therapeutics
Micro-segmentation in clinical trials is growing. When disease subtypes are already known, smaller clinical trials can be designed, and only those with a particular genetic signature recruited. Benefits include lower program costs and higher potential for drug efficacy with fewer adverse events.
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