Immuno-oncology has significant diagnostic needs, including identifying patients most likely to respond to therapies. Current diagnostic approaches often fall short, due in large part to the complexity of the biology driving therapy responsiveness. As such, the biopharma industry is exploring many emerging approaches covering tumor, immune and even microbiome-related pathways and biomarkers.

Highlights from this Executive Insights include:

  • Our understanding of the biology driving immuno-oncology therapy responsiveness is being accelerated by next-generation sequencing profiling of solid tumors linked to clinical and outcomes data, with tumor mutational burden being the prime example. 
  • The acceleration of scientific breakthroughs in immuno-oncology biology, pathways and biomarkers may simply outpace traditional pharma development. 
  • The pharma industry will need to grapple with what type of biomarker strategy to pursue in immuno-oncology. Standardization will be key. Pharma must also move away from tests that require specialized instrumentation and develop tests that fit better into therapeutic decision-making windows and health care economics.
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