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What’ s CDx?
• Companion diagnostic( CDx) is a diagnostic tool used to determine the suitability of a drug therapy to the patient. It has become a critical part of targeted cancer therapy that allows for development of personalized therapy can be developed and administered to the patient. Whole blood samples, tissues samples, or buccal samples are collected and tested for diagnosis and identification of targeted disease biomarker. CDx is usually utilized in identifying genetic mutations and the health and treatment approach implications.
• In July 2016, the U. S. FDA released a draft guideline for development of a therapeutic product accompanying an IVD companion diagnostic. Companion diagnostics include Gleevec( imatinib mesylate) and BCR-ABL LDT and DAKO C-KIT PharmDx, Herceptin( trastuzumab) and DAKO Herceptest; and Nolvaldex( tamoxifen) and laboratory-developed estrogen receptor positive test.
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