On October 24, 2022 Invivoscribe reported 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 CDx FLT3 Mutation Assay as the companion diagnostic for Daiichi Sankyo’s investigational drug quizartinib (Press release, Invivoscribe Technologies, OCT 24, 2022, View Source [SID1234622299]). 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 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 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.