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CLIA or FDA approval? – US Regulatory strategies for commercializing biomarker based tests

Current landscape of medical diagnostics,  public considerations and significance From a scientific perspective, this may be a “Golden Age” of diagnostics. The development of methods for identifying and quantifying minute amounts of biomarkers, and new computational techniques that allow the development of algorithms that define relationships between biomarkers and clinical conditions have combined to stimulate…Continue Reading…

Companion Diagnostics (CDx) – role of biomarkers and effective collaboration

The era of “one-size fits all” is slowly disappearing and tailored medicine is in great demand in todays world. The need for safer and effective drug therapy has lead pharmaceutical companies to a major paradigm shift in their business model.  In today’s drug development programmes, the identification and qualification of biomarkers are integrated.  Pharma companies…Continue Reading…

Biomarker discovery & validation: Shifting research away from silos & towards collaborative endeavours

A fundamental challenge in developing drugs for certain diseases is that there is relatively little known about the pathophysiology or the natural history of the disease. Moreover, there are only a small number of experienced clinical investigators worldwide and little scientific literature published. The consequence of this is that there is uncertainty about the disease…Continue Reading…