FDA granted an investigational device exemption for Adaptive Biotechnologies’ ClonoSeq MRD assay in a clinical trial sponsored by Imviva Biotech. The IDE covers use of ClonoSeq to support the TENACITY-01 Phase Ib/II study of CTD402, an allogeneic anti-CD7 CAR T-cell therapy. ClonoSeq will be used to identify patients with MRD levels at or above 0.1% for enrollment eligibility and to quantify MRD in post-treatment bone marrow samples for exploratory analyses. The companies also emphasized assay sensitivity—cited as detecting one cancer cell in one million healthy cells. For CAR T developers and sponsors pursuing MRD-guided strategies, the FDA IDE removes an additional gating item for trial operationalization and may help standardize ultra-sensitive measurement across sites.