Japan’s MHLW Approves Invivoscribe’s LeukoStrat CDx FLT3 Mutation Assay as the CDx for Daiichi Sankyo’s Quizartinib for Treatment of Relapsed/Refractory FLT3-ITD AML. Expands Use to Include Specimens Collected in EDTA
Invivoscribe is pleased to announce that on June 5th the Ministry of Health, Labor and Welfare (MHLW) approved our LeukoStrat® CDx FLT3 Mutation Assay as the companion diagnostic for Daiichi Sankyo’s Quizartinib for the treatment of FLT3-ITD positive relapse/ refractory acute myeloid leukemia (AML) patients in Japan. 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.
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The QuANTUM-R study demonstrated that quizartinib resulted in a statistically significant improvement in overall survival (OS) 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 FLT3 assessment for critically ill AML patients.
This PCR-based, in vitro diagnostic test detects internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) 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.
“Once again, our Streamlined CDx® program has demonstrated its effectiveness in accelerating submissions and approvals for our partners worldwide. Invivoscribe welcomes opportunities to partner with global pharmaceutical companies interested in developing and commercializing companion diagnostics, whether their therapies are targeting hematologic diseases or solid tumors.” said Dr. Jeffrey Miller, Invivoscribe’s CSO and CEO.
The LeukoStrat test is available as a test menu service through Invivoscribe’s wholly-owned subsidiaries, LabPMM LLC (San Diego, CA, U.S.), 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.
Invivoscribe is a global, vertically-integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics®. For nearly twenty-five years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality, standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies interested in developing and commercializing companion diagnostics, and provides expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization.
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