DNA Sequencing and Companion Diagnostics Next-generation sequencing (NGS) and screening platforms have multiple advantages over the current single-tes
{"Image DocumentName": "DNA Sequencing and Companion Diagnostics", "Image ImageDescription": "Next-generation sequencing (NGS) and screening platforms have multiple advantages over the current single-test, single-drug paradigm. Sponsors could obtain an Investigational Device Exemption (IDE) for the entire platform prior to the start of clinical testing. The presence of a particular predictive biomarker in the platform could enable the entire platform to be adequate for selecting patients. If the new drug demonstrated acceptable clinical benefit, the biomarker could be reviewed and given FDA clearance for diagnostic use, along with approval for the drug. Much like composite assays, if the platform used multi-markers for selection, the platform should not require separate clinical validation for each component.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}