Abstract
As the first CRISPR clinical trials begin this year in the U.S. and Europe, a number of genome-editing questions remain unanswered. One of the big ones: how to best measure whether a therapy is altering its target gene without introducing errors in others. To address that and other issues in the field, genome-editing companies and U.S. regulators teamed up at a workshop at the National Institute of Standards & Technology in April to start working out common standards that will promote better scientific understanding and confidence in therapies. The NIST Genome Editing Consortium is addressing fundamental questions about analytical measurements underlying gene editing. Among the most critical are “What DNA changes did you make when you did genome editing, and how do you know your measurements are giving you the right answer?” says Samantha Maragh, consortium organizer and leader of the genome-editing program at NIST. The consortium has three goals:
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