British genomics firm OGT received FDA de novo clearance for its CytoCell KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic for Syndax Pharmaceuticals’ Revuforj (revumenib). The assay detects KMT2A gene rearrangements in relapsed or refractory acute leukemia patients, crucial for identifying candidates who could benefit from this menin inhibitor treatment. OGT’s FDA clearance highlights advancements in precision oncology diagnostics tailored to genetic subtypes of leukemia.