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Companion Diagnostics CDx

What are CDx? Companion diagnostics (CDx) are precision medicine solutions in the form of diagnostic tests, often assays that are created alongside a drug to help guide drug development and treatment decisions. These tests are usually used for in-vitro analysis of specific biomarkers that provide information regarding the therapeutic efficacy and potential toxicity levels of the drug being developed.

What is the advantage of using CDx?

CDx depend upon the molecular understanding of the molecular pathophysiology of the disease and creating a targeted mechanism of action for the drug. Thus, CDx can be used to:

  • Identify the patients for whom the treatment will be beneficial.
  • Monitor the response of the treatment and adjust dosing to balance efficacy with safety.
  • Identify patients who would be at greater risk for adverse effects from the treatment being developed.

Source: Olsen, D., & JøRgensen, J. T. (2014). Companion Diagnostics for Targeted Cancer Drugs – Clinical and Regulatory Aspects. Frontiers in Oncology, 4. https://doi.org/10.3389/fonc.2014.00105