Developing and Labeling Companion Diagnostics for Multiple Oncology Therapeutic Products
This guidance describes considerations for developing and labeling in vitro companion diagnostic devices to support the indicated uses of multiple oncology therapeutic products. It aims to enable broader labeling claims for companion diagnostics when appropriate, rather than limiting labels to specific individual therapeutic products.
Recommended Actions
- Engage early with FDA (CBER, CDRH, or CDER) in coordination with OCE to discuss development plans
- Define specific group of oncology therapeutic products for companion diagnostic labeling
- Gather evidence demonstrating:
- Analytical validity across biomarker range
- Clinical validity with therapeutic products
- Understanding of mechanism of action and biomarker interactions
- Submit appropriate regulatory pathway (PMA supplement or new 510(k))
- Prepare labeling that:
- Specifies intended use with group of therapeutic products
- References FDA website for current product information
- Consider concordance studies or clinical validation if needed to demonstrate comparable performance
- Document resolution of any differences in technology or cut-offs between tests
Key Considerations
Clinical testing
- Sufficient clinical experience with at least two therapeutic products for the same biomarker-informed indications
- Clinical validity must be demonstrated with therapeutic products in the disease of interest
- Clinical validation may leverage existing data or require new studies showing concordance/comparable performance
Non-clinical testing
- Detailed understanding needed of:
- Mechanism of action of the therapeutic products
- Interaction between therapeutics and biomarkers at molecular level
- Prevalence of biomarkers in population
- Relationship between biomarker expression and therapeutic response
Labelling
- Must specify intended use
- Should name specific group of oncology therapeutic products rather than individual products when appropriate
- Should reference FDA website for current information on therapeutic products in the group
Other considerations
- Analytical validity must be demonstrated across biomarker range
- Different technologies and cut-offs between tests need to be evaluated
- Specific group of oncology therapeutic products must be clearly defined
- At least two FDA-approved therapeutic products should comprise the group
Relevant Guidances
- In Vitro Companion Diagnostic Devices: Development, Review Process, and Labeling Requirements
- In Vitro Companion Diagnostic Device and Therapeutic Product Co-Development (Draft)
Related references and norms
- 21 CFR 809.10: Labeling requirements for in vitro diagnostic products
- 21 CFR 860.7: Determination of safety and effectiveness
Original guidance
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