Invivoscribe Files sPMA for Leukemia Companion Diagnostic Test

Invivoscribe has submitted a supplemental premarket approval (sPMA) request for its LeukoStrat CDx FLT3 mutation assay as a companion diagnostic for Daiichi Sankyo's investigational drug quizartinib, both of which are focused on acute myeloid leukemia (AML) patients who have the FLT3-ITD mutation.

The polymerase chain reaction assay was first approved by the FDA in 2017 for use with Rydapt (midostaurin) to identify the mutation in newly diagnosed AML patients.

Mutations in the FLT3 gene occur in about one-third of all newly diagnosed adult AML cases. FLT3 is the most frequent genetic alteration and signals a poor prognosis.