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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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