Invivoscribe, a global, vertically-integrated biotechnology company, has announced that it has received FDA approval for its LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic to Daiichi Sankyo's VANFLYTA (quizartinib).

The assay aids in selecting patients with newly-diagnosed FLT3-ITD positive acute myeloid leukemia (AML), a blood cancer that affects the blood and bone marrow and is characterized by the rapid growth of abnormal white blood cells, who are eligible for VANFLYTA treatment. The PCR-based test detects internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations in the FLT3 gene in patients diagnosed with AML. The test is also used to assess patients for RYDAPT (midostaurin) and XOSPATA (gilteritinib) treatments.

The FDA approval marks a significant milestone for AML patients with FLT3-ITD positive diagnoses.