Skip to main content
Premium Trial:

Request an Annual Quote

Invivoscribe Gets FDA Approval for LeukoStrat CDx for Daiichi Sankyo Leukemia Drug

NEW YORK – Invivoscribe announced on Friday that its LeukoStrat CDx FLT3 Mutation Assay has received approval from the US Food and Drug Administration to select patients with FLT3-ITD positive acute myeloid leukemia who may be eligible for treatment with Daiichi Sankyo's Vanflyta (quizartinib).

The PCR-based test detects internal tandem duplication and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene from DNA extracted from peripheral blood or bone marrow aspirates of patients with acute myelogenous leukemia, Invivoscribe said in a statement. The assay runs on Thermo Fisher Scientific's Applied Biosystems 3500xL Dx Genetic Analyzer. 

Last October, the San Diego-based company filed a supplemental premarket approval submission with the FDA for this indication.  

The test was approved in 2019 for this indication by the Japan Pharmaceuticals and Medical Devices Agency. The assay also received approval under Europe's In Vitro Diagnostic Regulations in May.

"Timely and accurate testing for FLT3-ITD mutations in newly diagnosed patients is critical to identify those who may be eligible for treatment with Vanflyta, and we are happy to collaborate with Daiichi Sankyo to help bring this important new therapy to patients," Invivoscribe CSO, CEO and Founder Jeffrey Miller said in a statement.

Daiichi Sankyo announced on Thursday that the drug has been approved for the treatment of newly diagnosed FLT3-ITD positive AML patients. 

The assay is also approved for use as a companion diagnostic for AML patients considering treatment with Novartis' Rydapt (midostaurin) and Astellas Pharma's Xospata (gilteritinib).