Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labeling may contain information on genomic biomarkers and can describe:
Drug exposure and clinical response variability
Risk for adverse events
Genotype-specific dosing
Mechanisms of drug action
Polymorphic drug target and disposition genes
The table below lists FDA-approved drugs with pharmacogenomic information in their labeling. The labeling for some, but not all, of the products includes specific actions to be taken based on the biomarker information. Pharmacogenomic information can appear in different sections of the labeling depending on the actions. For more information, please refer to the appropriate labeling guidance.
This biomarker, called the KRAS-variant, is linked to more cancers than any other known inherited genetic mutation. It is present in 1 out of every 4 people with cancer, and in more than half of people who develop multiple cancers. KRAS-variant carriers tend to get highly aggressive and recurrent breast, ovarian, head and neck, lung and pancreatic cancers.
The researchers' approach to developing the method was adopted from food science, where it is used for control of complex industrial processes. Basically, it involves handling and analysing huge amounts of biological data in a holistic and explorative way. The researchers analysed all compounds a blood sample contains instead of - as is often done in health and medical science - examining what a single biomarker means in relation to a specific disease.
"When a huge amount of relevant measurements from many individuals is used to assess health risks - here breast cancer - it creates very high quality information. The more measurements our analyses contain, the better the model handles complex problems," continued Professor Rasmus Bro.
A new study from the Monell Center, the U.S. Department of Agriculture (USDA), and collaborating institutions reports a uniquely identifiable odor signature from mouse models of Alzheimer's disease. The odor signature appears in urine before significant development of Alzheimer-related brain pathology, suggesting that it may be possible to develop a non-invasive tool for early diagnosis of Alzheimer's disease.