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 for TENACITY-01, an open-arm Phase Ib/II study of Imviva’s allogeneic anti-CD7 CAR T, CTD402. ClonoSeq will be used to identify patients with minimal residual disease at levels of 0.1% or higher for enrollment eligibility and for exploratory quantification post-treatment in bone marrow samples. Adaptive Bio said ClonoSeq can detect one cancer cell in one million healthy cells. For MRD-guided therapy development, the IDE clearance is an execution step toward standardized, ultra-sensitive disease monitoring in interventional CAR T studies—potentially accelerating decision-making and earlier intervention designs.