Biomarkers are a very powerful tool in clinical diagnostics for diseases, especially cancer. More and more sensitive biomarkers are identified and applied in diagnostic assays providing valuable information about the disease status and helping doctors to identify suitable therapeutic modalities. The research is carried out in two directions: (1) identifying more meaningful and relevant biomarkers for a specific disease and used in early detection. This is done at the basic research level at academic labs as well as at industry (2) equally important step taken by the industry in developing technology to detect even the smallest traces of the biomarkers in the patient samples. Both aspects are very important and necessary to make significant advancement in disease management and cure.
Biomarker has a significant role in drug development as well. Biomarkers identifying specific disease phenotype are important for new drug development. Selective biomarkers can be used in parallel in drug development may reduce risk. A vast majority of drug candidates fail in final phases of the drug development cycle making the cost prohibitive. If there are very useful and relevant biomarkers applied during different phases of the drug development, the risk can be managed and reducing the overall cost of the drug development. A successful biomarker program will streamline the drug development pipeline and avoid less effective compounds in the pipeline.
One of the less used but a powerful tool in the biomarker arsenal is imaging biomarkers or i-biomarkers. I-biomarkers are especially valuable in accessing the drug penetration to the target tissue, target engagement, and confirming the expected results. Imaging is very widely used in clinical diagnostics of cancer. However the use of imaging technology for drug development has been slow to adopt. It is partly because of high cost of setting up a well equipped imaging center as well as developing image-based biomarkers. Companies such as Imanova provide a highly integrated solution for molecular imaging. Imanova provides help in patient selection, i-biomarker for labeling, rigorous preclinical evaluation to reduce the failure risk.
One another way to identify the engagement of the target is by cellular imaging of biomarkers from patient cells. This can be done by collecting the desired cells for evaluation, labeling for specific biomarkers, and imaging the changes to the cell population. In this area some of the very useful tools include modified cell culture products such as Multiwell Plates with Grids and Petridish with Grid pattern (Grid Plates), which allows for easy identification of cells, or colony of cells in the sample, and quantitate them. This easy to identify multiwell plates with grid and petridish with numbered grid are used in cell based assays, in cancer research as well as stem cell research. The grids allow for measuring positively stained cell number, cell location and colony size of the desired cells.
Biomarkers are a very significant part of basic research and increasingly important tool in clinical drug development in the pharmaceutical industry. There new tools are being developed to accelerate the process and reduce the risk of costly failure of compounds in the late stage development.