FDA minimal criteria: Diaceutics' opinion
8 Dec 2022
The concepts of precision medicine and personalized medicine date back to the 1990s when genetic information, environmental factors and lifestyle began to have an impact on the development of new drugs and their use instead of the usual one-drug-fits-all approach.
Diagnostic testing has always been fundamental to the precision medicine model as this is what enables physicians to select the most appropriate and optimal therapies based on a patient’s therapeutically actionable biomarkers. Today there are many successful stories of targeted therapies changing the landscape of cancer treatment with now well know biomarkers such as HER2, EGFR, BRCA, BRAF, PD-L1, ROS1, ALK, RET, MET, NTRK, etc.