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…

Diabetes prevention &/or treatment – Focus on the gut and nutrition? Role and benefits of biomarker discovery and validation.

There is the potential to significantly improve health by minor modifications to our diets in the form of biotics which could be bought relatively cheaply from your local grocery store and improve diabetic health. [1-3] Although diabetes covers two very different diseases (Type-1 and Type-2), they both have a common clinical endpoint: a reliance on…Continue Reading…

Biomarker discovery & validation – How to effectively manage data to maximize odds of projects succeeding

The ability to find and validate novel biomarkers rests on a combination of data available from literature sources, highly qualitative high-throughput data and unbiased analysis. The approaches used by research groups can be broadly classified as Data driven, Knowledge driven and Integrated. Out of the three, the integrated approach is likely to yield the best…Continue Reading…

Patent protection, trade secrets &/or open innovation in the successful path towards personalization of medicine

Traditionally, medicine relied on information such as family history, environment, behaviors and simple tests to tailor health care to patients. New discoveries are now enabling a unique and deeper understanding of individuals on a molecular level which are increasingly being translated into inventions with the potential to prevent, manage and cure a larger number of…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…