November 2025—The Food and Drug Administration has granted de novo classification for OGT’s CytoCell KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic for Syndax’s menin inhibitor, Revuforj (revumenib). Revuforj is FDA approved for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older. The test is used to detect rearrangement of the KMT2A region on chromosome 11 at location 11q23.3 in 3:1 methanol/glacial acetic acid fixed bone marrow specimens from patients who have acute leukemia with a KMT2A rearrangement. It is for in vitro diagnostic use.
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