The identification of these small molecule biomarkers holds a great promise for significant improvement of personalized medicine based on simple blood tests.For instance, diagnosis and prognosis with biomarkers (e.g.
Biomarkers that researchers currently look for are typically genes, proteins or metabolites that are associated with certain diseases.
The breast cancer drug Herceptin broke new ground in 1998 when it was approved along with a molecular diagnostic that could determine, based on a genetic biomarker, whether a person with breast cancer was part of the 30% of the population that would benefit from the drug.
The word “biomarker” describes a traceable and characterized substance that is an indicator of biological morphology, processes and function.
Disease biomarkers are used to diagnose various phases of diseases, monitor severities of diseases and responses to therapies, and are predictors of prognosis of patients and likely responses to therapy.
If trial sponsors can accurately select people that have a greater chance of being successfully treated based on their biological profiles, then they can reduce trial costs and time to approval a great deal.
Large pharmaceutical firms typically look for pharmacogenomic data to determine drug dosing schedules and not to develop treatments for genetically defined populations (, 590, 2003).
After-the-fact demographic analyses are currently the most common for identifying biomarkers, but this strategy is crude and inefficient and there is often no science to back up the resulting correlation.
Preclinical validation of biomarkers would be ideal, but this is often unrealistic considering the infancy of pharmacogenomics.
carcinoembryonic antigen (CEA)) has significantly improved patient survival and decreased healthcare costs in colorectal cancer patients.
Unfortunately, despite significant investments to increase the number of biomarker studies, only ~150 out of thousands of identified biomarkers have currently been implemented in clinical practice.
But Susan Arbuck, global head of the oncology therapeutic area at Aventis Pharmaceuticals (Bridgewater, NJ, USA), says that although incorporating molecular profiling into clinical trials will segment the market of a single indication, it has the potential to increase market penetration by easing the identification of successful patients across indications.