Posted by Michael Wonder on 24 Oct 2022
Invivoscribe files sPMA with the FDA for use of the LeukoStrat CDx FLT3 mutation assay to select patients with newly diagnosed FLT3-ITD positive AML
24 October 2022 - Invivoscribe is pleased to announce that they have filed a supplemental pre-market approval submission with the US FDA Center for Devices and Radiological Health for the use of the LeukoStrat CDx FLT3 mutation assay as the companion diagnostic for Daiichi Sankyo's investigational drug quizartinib.
The assay is used for the identification of newly diagnosed acute myeloid leukaemia patients that have the FLT3-ITD mutation.
