Partnership Opportunities

To enable successful drug-companion diagnostic co-development, important factors are:

• Clinical utility statement: What is the marker being used for?
• What is the aim, as in:
  • Prognostic (related to disease outcome) or
  • Predictive biomarker (related to treatment outcome)
• How is the clinical trial to prove utility constructed?
• Should an enrichment or patient selection strategy be used?

External factors that need consideration

• Regulatory environment: What constitutes an acceptable companion diagnostic or biomarker?
• Reimbursement: What is the appropriate reimbursement strategy and what is required to convince insurers to pay?

To deal with these questions and increase the success rate of companion diagnostic tests, and therefore the success of the drug candidate, Mira Dx® offers a number of ways to collaborate. As one part of that collaboration Mira Dx® offers access to its CLIA laboratory to develop the biomarkers into Lab Developed Tests (Ltd’s) early on in the process to eliminate any assay associate failures.  With our rich pipeline of biomarker candidates that are functional we can often predict based on pathway which biomarkers have the best chance of success for which agent.

To learn more please contact us.