FDA granted an investigational device exemption for the use of Adaptive Biotechnologies’ ClonoSeq assay in a clinical trial sponsored by Imviva Biotech. The IDE covers TENACITY-01, evaluating Imviva’s allogeneic anti-CD7 CAR T-cell therapy CTD402 in relapsed or refractory T-ALL/LBL and in remission settings with minimal residual disease. 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. Adaptive Bio said ClonoSeq can detect one cancer cell in one million healthy cells, emphasizing the assay’s sensitivity for MRD-guided decision-making. The IDE highlights how regulators continue to formalize companion diagnostic-like roles for MRD assays inside interventional CAR-T trials, aiming to standardize sensitivity across sites.