Which statement about companion diagnostic labeling is true?

Which statement about companion diagnostic labeling is true?

• A. It must identify the therapeutic product with which it is cleared to be used
• B. It must include patient names
• C. It must include manufacturing date only
• D. It must include pricing

Answer: (A)

Companion diagnostic labeling must specify the therapeutic product it is cleared to be used with. This creates the essential drug–device (test) pairing: the test is designed to identify patients who are likely to benefit from that exact therapy or who may be at risk if treated with it. By tying the diagnostic to a specific drug, the label guides clinicians in selecting the right patients and ensures the test is used in the intended treatment context, which is crucial for safety and effectiveness. Labels do not include patient names, manufacturing dates, or pricing. These elements are not part of regulatory labeling requirements for a companion diagnostic and would raise privacy or commercial concerns or simply lie outside the scope of diagnostic indication and usage.

Companion diagnostic labeling must specify the therapeutic product it is cleared to be used with. This creates the essential drug–device (test) pairing: the test is designed to identify patients who are likely to benefit from that exact therapy or who may be at risk if treated with it. By tying the diagnostic to a specific drug, the label guides clinicians in selecting the right patients and ensures the test is used in the intended treatment context, which is crucial for safety and effectiveness.

Labels do not include patient names, manufacturing dates, or pricing. These elements are not part of regulatory labeling requirements for a companion diagnostic and would raise privacy or commercial concerns or simply lie outside the scope of diagnostic indication and usage.