British genomics company OGT secured FDA de novo authorization for its CytoCell KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic (CDx) for Syndax’s Revuforj (revumenib) in relapsed or refractory acute leukemia carrying KMT2A gene translocations. The FDA noted that detecting KMT2Ar is critical for identifying patients eligible for menin inhibitor therapy, a population historically facing poor prognosis. OGT's assay offers a targeted diagnostic solution to enable precision oncology treatment decisions, marking a significant step in integrating molecular diagnostics with therapeutic approaches.