U.S. Food and Drug Administration Authorizes CytoCell KMT2A Breakapart FISH Probe Kit PDx as a New Companion Diagnostic for KMT2A rearranged Acute Leukaemia
Oxford, UK – 22nd September 2025. OGT, a leading global provider of genomic diagnostic and research solutions, announced today that the U.S. Food and Drug Administration (FDA) has granted their De Novo Classification Request for the CytoCell® KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic (CDx) for Syndax’s first-in-class menin inhibitor, REVUFORJ® (revumenib).