Global Companion Diagnostic Strategy

Working with a new player with a target therapeutic in a particular solid tumor indication, we helped our client prioritize markets and developed a set of tactics to address adoption barriers that were unique to each country.


  • A major multinational pharmaceutical company had developed a novel tyrosine kinase inhibitor (TKI) for the treatment of metastatic non-small cell lung cancer (NSCLC).
  • The novel TKI required diagnostic mutation testing for patients to ensure only mutation-positive patients received treatment. In order to best facilitate patient treatment, the company had to consider the optimal diagnostic strategy for global adoption of pathologic testing for the specific mutation.
  • Health Advances was engaged to develop country-specific strategic roadmaps for implementation of a diagnostic strategy that would provide the easiest and most effective testing that enabled treatment with the novel TKI.

Critical Questions to Address

  • What is the current laboratory infrastructure in each country? How is testing currently distributed, coordinated, and performed between hospitals and reference laboratories?
  • What technologies are currently used to perform lung cancer diagnostic testing today?
  • How frequently is testing for the TKI’s specific mutation performed today? What are the unmet needs and barriers to performing this testing for all patients or earlier in the diagnostic paradigm?
  • What future shifts are anticipated in lung cancer diagnostic testing? Which specific diagnostic technologies are the most feasible and preferred in the near and long term for testing of the TKI’s specific mutation?

Health Advances Approach

  • Assess current diagnostic paradigm, laboratory infrastructure, and frequently used pathology techniques in each country through primary and secondary research
  • Create country prioritization tool for assessing market attractiveness, diagnostic demand / access, and potential for added benefit from sponsor
  • Develop strategic action plan for each country with tailored solutions and detailed short, mid, and long term tactics to increase access and demand for testing


  • Health Advances created customized strategic roadmaps and tactical solutions for optimizing lung cancer diagnostic testing for Marker X and access to the novel TKI in 12 major global markets across 4 continents
  • Health Advances provided continuing support to the company’s global, regional, and country teams by through the implementation process
  • The client has since implemented multiple tactics including specific physician education symposia, lab mapping initiatives, and diagnostic partnerships which have helped support the launch an adoption of the novel TKI