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Value Of A Biomarker Lies In Its Clinical Relevance
Biomarker identification and characterization has undergone a revolution since the availability of the Human Genome sequence and significant advances in instrumentation to study genes and proteins in human disease. A reliable biomarker allows insight into a disease pathway, and further supported by laboratory and clinical evidence, should potentially lead to drug or diagnostic targets. Multiple molecular approaches are available today to a researcher to examine gene mutations, gene expression or protein patterns and their combinations for correlation with disease and treatment response. Arguably, this has also led to biomarkers that are limited in by clinical definition and validation.
Molecular profiling involves a thorough investigation of patterns in DNA (genetics), RNA (genomics), protein (proteomics) and even metabolites (metabolomics) associated with a phenotype or clinical outcome. Of these approaches, microarray profiling using gene chips to analyze mutations or gene expression is a technique with amenability to clinical diagnostic development. A genome-wide scan of gene expression profiles can help describe tumor characteristics, individual differences, and selective response to drug treatment.
In order to maintain high clinical relevance, Nuvera's approach is to develop multi-gene expression profiles from prospective trials of specific treatment regimens. These are currently conducted at MD Anderson Cancer Center and several other collaborators world-wide.
In addition, Nuvera has developed a sophisticated bioinformatics platform to derive significant predictive genes for clinical outcomes. The biocomputational infrastructure consists of both supervised and unsupervised algorithms that allow discovery of predictive patterns as well as validation of the diagnostic classifier of response with high statistical confidence.
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