A new, publicly available test to assess the safety of cell therapy products altered by lentivirus generates results within a few hours, potentially hastening the pace at which viral immunotherapies move into clinical trial. Current assays required by the U.S. Food and Drug Administration take about six weeks to complete. The rapid test, which does not have a significant risk of false positives, is also a fraction of the cost of the standard approach. The work appears September 21 in the journal Molecular Therapy—Methods & Clinical Development.
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