Global Companion Diagnostic Guideline Mapping and Strategy

Pharma & Biotech
Stakeholder Interviews
Countries / Regions Profiled
Guideline Bodies Evaluated
Project Details
Biomarker and Diagnostics Strategy
Go-to-Market Strategy


A large pharma new to precision oncology wanted to understand the processes and requirements to ensure that their novel CDx was included into diagnostic guidelines globally

Our Approach

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.


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.

Precision Medicine is evolving at a rapid pace

Discover how we can help

Get in Touch