Companion Diagnostics
A companion diagnostic (λλ°μ§λ¨κΈ°κΈ°) is an IVD essential for the safe and effective use of a specific therapeutic. Classified at Grade C or D under the IVD Act.
Regulatory coordinationβ
- Companion diagnostic and associated drug must be approved together or reference the approved drug
- MFDS pharmaceutical division confirms clinical claims align with drug's approved indications
- Review timelines aligned with the drug approval
Technical requirementsβ
- Full analytical and clinical performance evaluation
- Studies demonstrating patient response aligns with test result
- Co-validation with the drug/biological in the same patient population
Labellingβ
Must clearly state: the linked therapeutic product name; the patient population; the clinical decision based on the test.