How to Use Microbiome Signatures as Biomarkers

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Biomarkers play an increasingly important role when it comes to reimbursement decisions for new therapies based on cost-effectiveness. A high number of approved drugs currently in the market have a patient benefit ratio of 25%, at best, to an appalling low ratio of 4%. Interestingly and unexpectedly, the target indications for the drugs listed within this white paper have all been recently linked to dysbiosis in the microbiome.

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This paper provides an introduction to microbiome-based biomarkers and the use of microbiome data as one component of a larger data profile for individuals in today’s era of precision medicine:

  • The application of biomarkers enabling “targeted therapies” or serving as surrogate efficacy markers to shorten otherwise lengthy clinical trials.
  • How microbiome information may be used for risk prediction, diagnosis and progression of disease and for stratification of subjects in clinical drug trials.
  • The role biomarkers play in reimbursement decisions for new therapies based on cost-effectiveness.
  • An example process for biomarker identification and validation.
  • How a customized approach, sequencing depth, and delivery of high quality data are able to infer metabolic potential for more targeted hypothesis generation.

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