The FDA granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Nanoneedle/Tessie platform, validating a multiplex assay for direct measurement of AAV vector genome integrity and capsid titers. The designation grants the company prioritized regulatory interactions and signals agency interest in tools that strengthen quality control for AAV gene therapies. NanoMosaic says its assay reduces sample consumption and assay time while providing critical quality attributes that are actionable during upstream and downstream manufacturing. The AMT status could shorten reviews and increase industry adoption of the platform for IND and BLA development programs.