Companion Diagnostics and Gene Panel Testing

• Companion Diagnostics 
  • Companion diagnostics refer to testing agents used to check in advance "whether a specific drug will be effective for a patient" before using that therapeutic drug. 
  • "Companion" has the meaning of "accompanying" or "going along with". 
  • Therapeutic drugs and diagnostics correspond "in principle on a 1-to-1 basis," like the relationship between a specific "key (drug)" and a "keyhole (gene, etc., examined by the diagnostic)".
  • Information on Companion Diagnostics, etc. | Pharmaceuticals and Medical Devices Agency (PMDA)
  • Companion Diagnostics | Pharmaceuticals and Medical Devices Agency (PMDA)

 

• Cross-drug Companion Diagnostics 
  • It refers to a diagnostic agent that can be used commonly not just for a specific single drug, but for "multiple drugs having the same target (biomarker).
  • Under previous rules, even if drugs targeted the same gene mutation, separate testing agents (1-to-1) were linked to each drug. 
  • The regulation was relaxed and reorganized into a form where "if positive in a certain test, Drug A, Drug B, and Drug C can all be used" (1-to-many); this is what constitutes cross-drug companion diagnostics.
  • (Copy) (1) On the Handling of In Vitro Diagnostic Products, etc., Intended for Drug-Agnostic Companion Diagnostics
  • Microsoft Word - (Copy) (1) Q&A Collection on the Handling of In Vitro Diagnostic Products, etc., Intended for Drug-Agnostic Companion Diagnostics.docx

 

• Gene Panel Testing 
  • This is a test to examine changes in multiple genes occurring in cancer cells at once to understand the characteristics of the cancer. 
  • Depending on the gene changes, it may be possible to identify drugs that are likely to be effective. 
  • What is Cancer Gene Panel Testing | Cancer Genomic Medicine and Cancer Gene Panel Testing | National Cancer Center, Cancer Genome Information Management Center (C-CAT)
  • Frequently Asked Questions | National Cancer Center Hospital

 

• Consultation Desks 
  • It is recommended to first consult regarding the applicability as a medical device or in vitro diagnostic agent and the regulatory process through PMDA's RS consultation, etc.
  • If it is still in the research stage and has not yet reached the prototype level, it would be good to brainstorm regarding methods for commercialization at consultation desks of public institutions such as MEDISO. 
  • It is also recommended to utilize the hands-on support provided by public institutions. ​

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