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FDA's CDx guidance is causing a flood of biomarkers to hit the market, the vast majority are detected by molecular tools such as PCR or NGS
FDA's CDx guidance requires all oncology therapies to have a molecular biomakers and CDx device to ensure the correct diagnosis is made
The increase in CDx biomarkers is resulting in more complex diagnosis and staying on label is not easy. Below image shows the 7 approved biomarkers for EGFR and the approved diagnostic pathways to reach therapy.
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