Global Companion Diagnostic Guideline Mapping and Strategy

Secondary Research

• Reviewed the current diagnostic and cancer-specific guidelines for each country / region of interest (e.g., U.S., UK, Germany, France, Italy, Spain, Scandinavia, Canada, Brazil, China, and Japan) to establish the current testing guidelines and review the data requirements and guideline submission / review timeline and processes.

Primary Research

• Conducted 49 interviews with pathologists and guideline agency stakeholders to identify the most influential guidelines for IHC CDx testing and understand the process and requirements for implementing a novel companion diagnostic in the lab.
• Assessed adjacent sources of information that influence new biomarker adoption and testing among pathologists.

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DeciBio created a tactical checklist and timeline of key actions and data the client needed to generate to support guideline inclusion in each market. We established a profile for each high-impact guideline, summarizing the submission process, key individuals, and data requirements to warrant inclusion in the guideline. DeciBio presented the findings to each of the market teams within the organization.