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Companion and Complementary Diagnostics: Clinical and Regulatory Perspectives
1Dx-Rx Institute, Baunevaenget 76, 3480 Fredensborg, Denmark.
Trends in Cancer
|July 26, 2017
Summary
Companion and complementary diagnostics guide personalized medicine. Companion diagnostics are required for specific drugs, while complementary diagnostics aid treatment decisions, both focusing on individual patients for tailored pharmacotherapy.
Area of Science:
- Biomarker Assays
- Precision Medicine
- Pharmacotherapy
Background:
- The US Food and Drug Administration (FDA) approved the first companion diagnostic assay nearly 20 years ago.
- Companion diagnostics currently govern the use of 18 different drugs.
- The emergence of PD-L1 IHC assays for immune checkpoint inhibitors has introduced complementary diagnostics.
Purpose of the Study:
- To discuss companion and complementary diagnostics.
- To highlight their role in individualized pharmacotherapy.
- To emphasize their importance in achieving precision medicine.
Main Methods:
- Review of companion diagnostic assays.
- Analysis of complementary diagnostic assays, including PD-L1 IHC.
- Discussion of the role of these assays in clinical decision-making.
Main Results:
- Companion diagnostics are prerequisite tests for specific drug therapies.
- Complementary diagnostics provide predictive biomarker information to aid therapeutic decisions.
- Both assay types are patient-centric and crucial for personalized medicine.
Conclusions:
- Companion and complementary diagnostics are essential for advancing precision medicine.
- These assays facilitate individualized pharmacotherapy by informing treatment choices.
- The development and utilization of these diagnostic tools are critical for future healthcare.
Keywords:
PD-L1companion diagnosticscomplementary diagnosticsimmune checkpoint inhibitorspersonalized medicineprecision medicineMore Related Videos
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