NEW YORK (GenomeWeb) – Invivoscribe Technologies said today that it has released a new CE-marked IVD version of its LeukoStrat CDx FLT3 Mutation Assay, which was approved earlier this year by the US Food and Drug Administration.
The test is the first companion diagnostic for acute myeloid leukemia, and identifies both internal tandem duplication (ITD) and tyrosine kinase domain mutations, including large ITD alterations missed by other NGS-based assays.
This April, the FDA approved the assay — run out of Invivoscribe subsidiary the Laboratory for Personalized Molecular Medicine — as a companion diagnostic to Novartis' acute myeloid leukemia drug Rydapt (midostaurin) in combination with chemotherapy.
Under the terms of a previously announced agreement with Thermo Fisher, Invivoscribe has said it will also seek FDA approval of an in vitro diagnostic version of the test that it can sell to other US laboratories.
The newly announced CE-IVD version includes CE-marked software that interprets data, generates mutant/wildtype signal ratios for ITD mutations, and predicts response to midostaurin.
"As has been noted by others, there is a need for an internationally standardized FLT3 mutation assay and release of this product helps fulfill that need," Invivoscribe CEO and chief scientific officer Jeffrey Miller said in a statement.