FDA Gives Emergency Authorization for CRISPR-Based Diagnostic Tool for Coronavirus

The Food and Drug Administration on Thursday, May 7, approved a new diagnostic tool that employs the revolutionary CRISPR gene-editing technology to determine if someone is infected with the novel coronavirus.

The FDA’s emergency use authorization allows only “high-complexity” laboratories to use the test kit, developed by researchers at the Massachusetts Institute of Technology, Harvard University, the Ragon Institute and the Howard Hughes Medical Institute and marketed by Sherlock Biosciences of Cambridge, Mass.

The inventors of the FDA-authorized test are developing a simplified version they hope will eventually be approved for point-of-care or in-home use.

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