FDA wades into sequencing-based diagnostics regulation
The US Food and Drug Administration (FDA) has proposed a series of practical steps aimed at answering key issues surrounding next-generation sequencing (NGS) diagnostic tests and their use in precision medicine. The agency in collaboration with a number of stakeholders published a Perspective in Science Translational Medicine (8, 335, 2016) that outlines nine research challenge areas that must be explored to inform the regulation of NGS tests. The ‘roadmap’ published on April 20 lays out research plans to gain a better understanding of NGS products, how they are developed and the degrees of certainty that each method provides. The publication has drawn a mixed reaction from firms and laboratories that offer NGS-based diagnostics. Some welcome the roadmap but others remain wary of the agency’s involvement and the potential hurdles that may result from tightening regulations. Read more here.
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