Clonal Analysis
 

Clonal Analysis. For certain gene therapy clinical trials, the FDA has required post-trial monitoring of patients, evaluating clinical samples for evidence of clonal expansion of cells (PDF). To help academic investigators comply with this FDA recommendation, the NGVB offers assistance with clonal analysis using nrLAM PCR technology. Contact the NGVB Coordinating Center for more information.

FDA Gene Therapy Guidance
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