FDA approves companion diagnostic for AML drug Rydapt

Invivoscribe Technologies Inc. (San Diego, Calif.) said FDA approved its Leukostrat CDx FLT3 Mutation Assay as a companion diagnostic for acute myelogenous leukemia (AML) drug Rydapt midostaurin from Novartis AG (NYSE:NVS; SIX:NOVN). The in vitro diagnostic identifies the FMS-like tyrosine kinase 3 (FLT3; CD135) mutation in AML patients. Invivoscribe said the assay is the first FDA-approved companion diagnostic for AML. FDA approved Rydapt in April to treat newly diagnosed FLT3-positive AML. Rydapt is an FLT3 and stem cell factor (SCF) receptor tyrosine kinase (c-Kit; KIT; CD117) inhibitor.

Invivoscribe said under the current U.S. label, Leukostrat must be exclusively performed by its subsidiary The Laboratory for Personalized Molecular Medicine. Invivoscribe plans to seek FDA approval to allow sale of the Leukostrat kit to other laboratories. In January, Invivoscribe said it would seek approval of the FLT3 mutation assay to run on the Applied Biosystems 3500 Dx capillary electrophoresis platform from Thermo Fisher Scientific Inc.(NYSE:TMO) under an expanded 2016 deal...