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Twenty-five years with companion diagnostics
1Department of Medical Science, Dx-Rx Institute, Fredensborg, Denmark.
Companion diagnostics (CDx) are predictive biomarkers essential for safe and effective drug use. Over 25 years, the FDA has approved over 60 CDx assays, primarily in oncology, improving personalized medicine.
Area of Science:
- Biomarkers and Personalized Medicine
- In Vitro Diagnostics
- Pharmacotherapy
Background:
- Patient variability in pharmacotherapy has historically limited treatment efficacy.
- Advances in molecular medicine have enabled the development of predictive biomarkers.
- Companion diagnostics (CDx) are crucial predictive biomarkers for targeted therapies.
Purpose of the Study:
- To discuss companion diagnostics (CDx).
- To provide an overview of CDx evolution over the past 25 years.
- To emphasize the role of CDx in the United States.
Main Methods:
- Review of FDA-approved companion diagnostics.
- Historical analysis of CDx development and adoption.
- Focus on the United States regulatory landscape.
Main Results:
- The first CDx assay, HercepTest for HER2, was FDA-approved 25 years ago.
- Over 60 CDx assays are now linked to FDA-approved drugs, mainly in oncology.
- CDx has significantly advanced personalized medicine, particularly in cancer treatment.
Conclusions:
- Companion diagnostics are integral to modern pharmacotherapy.
- The evolution of CDx demonstrates significant progress in personalized medicine.
- Continued development of CDx is vital for optimizing drug efficacy and patient outcomes.
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