FDA authorizes new companion diagnostic for KMTA-rearranged acute leukemia

The US Food and Drug Administration (FDA) has granted a De Novo Classification Request for the CytoCell KMT2A Breakapart FISH Probe Kit PDx, a new companion diagnostic to the menin inhibitor revumenib (Revuforj®).

The diagnostic test detects clinically relevant rearrangements that occur in patients with acute leukemia. The test is accessible and has fast turnaround times, according to OGT, a Sysmex Group company, the manufacturer of the test.

“Accurately identifying acute leukemia patients with KMT2Ar is a key factor in selecting appropriate therapeutic options for a group of patients who have traditionally had a very poor prognosis,” said Adrian Smith, CEO of OGT. “We are optimistic that the authorization of OGT’s CDx will help this underserved patient group benefit from developments in precision oncology.”