Glossary Term
Companion Diagnostics (CDx)
Definition
Companion Diagnostics (CDx) are medical devices, often in the form of in vitro diagnostic tests, that provide information essential for the safe and effective use of a corresponding drug or biological product. They are used to identify patients who are most likely to benefit from a specific therapy, avoid harmful side effects, or monitor treatment response.
Relevance to the MedTech Industry
CDx devices are integral to the rise of personalized medicine, ensuring that therapies are tailored to individual patients based on their genetic, molecular, or biomarker profile. They improve treatment outcomes, reduce adverse reactions, and optimize healthcare resources by guiding therapeutic decision-making.
Additional Information & Related Terms
Personalized Medicine CDx enables therapies tailored to individual patients.
Biomarker A measurable indicator used by CDx to guide therapeutic decisions.
In Vitro Diagnostic (IVD) A category under which most CDx tests are regulated.
Regulatory Submissions Critical for obtaining approval for both CDx devices and their associated therapies.