OGT announces that the US Food and Drug Administration (FDA) has granted its 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).
Revuforj is FDA approved for the treatment of relapsed or refractory (R/R) acute leukaemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and paediatric patients one year and older.
OGT’s CytoCell KMT2A Breakapart FISH Probe Kit PDx detects clinically relevant rearrangements that occur in patients with acute leukaemia, providing a robust, accessible, and rapid turnaround test for KMT2A detection that maximises the ability for clinicians to quickly identify patients who may be eligible for treatment with Revuforj.
It is estimated that more than 95% of patients with KMT2Ar acute leukaemia have a KMT2A translocation, a type of rearrangement that occurs when part of one chromosome breaks and fuses to a different chromosome.
“We are delighted that our CytoCell KMT2A Breakapart FISH Probe Kit PDx has received marketing authorisation as a CDx for Revuforj,” said Dr Leila Luheshi, VP of Pharma Partnering at OGT.
“The development and subsequent authorisation of this new CDx is an important demonstration of the skill and commitment of our clinical scientists and regulatory specialists to deliver safe and effective diagnostics for patients with one of the most devastating forms of leukaemia.”
Steve Chatters, OGT’s EVP of Regulatory and Medical Affairs, noted: “Our strong foundation in haematology diagnostics has been a key factor in our success bringing the KMT2Ar CDx to market as a Class II device, as opposed to the more common Class III classification for companion diagnostics."
"We have decades of experience developing regulated FISH products, gained from our prior development of IVDR-certified and FDA-cleared FISH probes. "C
"Combined with our extensive customer partnerships in haematology labs in the USA, we have refined insights into the application of these products and can access a wealth of real-world data across a multitude of clinical and analytical factors, which is invaluable for product development. This is a core pillar of our success."
“Accurately identifying acute leukaemia 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 authorisation of OGT's CDx will help this underserved patient group benefit from developments in precision oncology.”