Regulatory and Reimbursement Issues in Biomarkers

To get the coverage and reimbursement remained a primary hurdle towards the adoption of new Biomarker testes for d3edliest diseases like cancer. If certain tests are not accepted by the regulatory bodies, and insurance companies,  it highly impacts the entrant of new Biomarker tests. The Centers for Medicare & Medicaid Services identified only 65 tests under the reimbursement category. Any test beyond that although useful may not reimburse hence creates a huge challenge.  

  • Policy environment for Biomarker tests for Molecularly Targeted Therapies
  • Challenges and Issues in Biomarkers development
  • Policy issues in development and adoption of Biomarkers for Molecularly Targeted Cancer Therapies
  • Policy issues in the development of Personalized Medicine
  • coverage and reimbursement issues in Cancer biomarkers
  • Biomarkers & Drug labeling
  • Identification of molecular Biomarkers of clinical utility
  • Ethical, legal and social implications (ELSI) of Biomarkers
  • Difficulties in the development of an evidence base for evaluation of Biomarkers

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