24 June 2019 - - The Ministry of Health, Labor and Welfare approved US-based biotechnology company Invivoscribe's LeukoStrat CDx FLT3 Mutation Assay as the companion diagnostic for Japanese drugmaker Daiichi Sankyo's Quizartinib for the treatment of FLT3-ITD positive relapse/ refractory acute myeloid leukemia patients in Japan, the company said.
At the same time the Japanese MHLW added approval in use of EDTA collection tubes to the existing approval of heparin collection tubes used with this assay.
The QuANTUM-R study demonstrated that quizartinib resulted in a statistically significant improvement in overall survival compared to salvage chemotherapy when patients were selected with the LeukoStrat CDx FLT3 Mutation Assay.
Mutations in the FLT3 gene are among the most important driver mutations in AML.
This milestone further establishes the LeukoStrat CDx FLT3 Mutation Assay as the international gold standard for comprehensive FLT3assessment for critically ill AML patients.
This PCR-based, in vitro diagnostic test detects internal tandem duplication mutations and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with AML.
This test, which is available worldwide, includes software that interprets data, generates standardized mutant/wildtype signal ratios for ITD and TKD mutations, and predicts response to multiple tyrosine kinase inhibitors.
The LeukoStrat test is available as a test menu service through Invivoscribe's wholly-owned subsidiaries, LabPMM LLC (San Diego, CA, US), LabPMM GmbH (Martinsried, Germany) and LabPMM GK (Kawasaki City, Japan).
Greater than 95% of patient samples tested using the FDA-approved LeukoStrat CDx FLT3 Mutation Assay and selection of other CLIA-validated PCR-based capillary assays report out results within 48 hours of sample receipt at any of the LabPMM laboratories.
LeukoStrat CDx FLT3 Mutation Assay kits are currently distributed in Japan, Europe, and Australia, and are planned for distribution in the United States and China in the future.