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Invivoscribe files sPMA with the FDA for use of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with Newly Diagnosed FLT3-ITD Positive AML


Invivoscribe is pleased to announce that they have filed a supplemental Pre-Market Approval (sPMA) submission with the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) for the use of the LeukoStrat(R) CDx FLT3 Mutation Assay as the companion diagnostic for Daiichi Sankyo’s investigational drug quizartinib. The assay is used for the identification of newly diagnosed acute myeloid leukemia (AML) patients that have the FLT3-ITD mutation.

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The filing supports Daiichi Sankyo’s new drug application (NDA) for quizartinib for the proposed treatment of adult patients with newly diagnosed FLT3-ITD positive AML, which was granted Priority Review by the FDA. Previously, the LeukoStrat CDx FLT3 Mutation Assay was approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for use as a companion diagnostic to select relapsed and refractory AML patients eligible for quizartinib in Japan.

“Invivoscribe’s filing with the FDA for the use of the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for quizartinib is an important milestone. This submission to the FDA further solidifies the LeukoStrat CDx FLT3 Mutation Assay as the international benchmark for FLT3 mutation assessments. We are delighted that our Streamlined CDx(R) program continues to expand and expedite the global approval of critical oncology treatments,” said Dr. Jeffrey Miller, Invivoscribe’s CSO and CEO.

Mutations in the FLT3 gene are among the most important driver mutations in AML, with approximately one-third of all newly diagnosed adult cases containing FLT3 mutations. The FLT3 internal tandem duplication (ITD) mutation occurs in about 25%, and the tyrosine kinase domain (TKD) mutation occurs in approximately 5% of all newly diagnosed patients with AML.[1]

Invivoscribe’s companion diagnostic is an in vitro PCR test which detects both ITD mutations and 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.

LeukoStrat CDx FLT3 Mutation Assay kits are currently distributed in Japan, the United States, Europe and China. The LeukoStrat CDx FLT3 Mutation Assay is also available in Japan, Germany and the United States as a service through Invivoscribe’s wholly-owned LabPMM(R) subsidiaries. Greater than 95% of patient samples tested using the FDA-approved LeukoStrat CDx FLT3 Mutation Assay and a selection of other CLIA-validated PCR-based capillary assays report out results within 48 hours of sample receipt at any of the LabPMM laboratories.

About Invivoscribe

Invivoscribe is a global, vertically-integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics(R). For nearly thirty 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. For additional information, please contact Invivoscribe at: or follow Invivoscribe on Linked In.

[1] Kennedy VE, Smith CC. (2020) Front Oncol. 10:612880.

SOURCE Invivoscribe Technologies, Inc.

CONTACT: Tony Lialin,