An Analysis Approach to Identify and Qualify Candidate Cross-Species Biomarkers

Daniels, Kellye K.; Mendrick, Donna L.
September 2006
Pharma DD: Tracking Discovery & Development;Sep/Oct2006, Vol. 1 Issue 2, p30
Academic Journal
Genomic technologies offer a significant advantage to the identification of a biological biomarker, defined as "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention" (1); given that, transcript profiling can monitor thousands of possible endpoints simultaneously (2). Large genomics databases, such as Gene Logic's ToxExpress and BioExpress System databases, can provide in silica data on potential biomarkers, including distribution in human normal and disease-state tissues, preclinical compound treatment toxicity effects, and tissue distributions across multiple species. While genomic findings are only the first step in biomarker identification and qualification (they must be followed up with protein, enzyme, or metabolite measurements and a solid validation strategy), genomics is an enabling technology for this application. A case study illustrating such is provided by the identification and qualification of the fetuin-B gene as indicative of chronic liver disease.


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