Omics, Biomarkers and New Technologies
Traditional in vivo and in vitro assays have relied on measuring a few parameters at best, such as changes in the levels of a particular chemical, signalling mediator or hormone in the body.
This approach provides a mere snapshot of the possible effects of a substance within the body, such that clinical signs in animal tests or effects seen in cell-based assays do not reliably translate to monitoring the effects of a substance during human studies.
This has been attributed to the high rate of drugs failing to reach clinical use or they are subsquently withdrawn because of adverse side effects. The US Food and Drug Administration (FDA) is looking at how new technologies based on using biomarkers can help to reduce the incidence of these problems.
Biomarkers may be biochemical or metabolic, related to genes and their expression patterns under different circumstances or in different individuals. These biomarkers are discovered by monitoring a broad range of changes in gene expression, protein levels or metabolites and are encompassed in the fields of genomics, proteomics and metabonomics, respectively.