- Invivoscribe Announces FDA Approval of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with FLT3-ITD-Positive AML for Treatment with VANFLYTA
SAN DIEGO, July 21, 2023 /PRNewswire/ -- Invivoscribe is pleased to announce that the LeukoStrat® CDx FLT3 Mutation Assay has been approved by the US Food and Drug Administration (FDA) to aid in the selection of patients with newly diagnosed FLT3-ITD-positive acute myeloid leukemia (AML) who may be eligible for treatment with VANFLYTA® (quizartinib). ) by Daiichi Sankyo.
The LeukoStrat CDx FLT3 Mutation Assay identifies patients with FLT3-ITD-positive AML who can be treated with this newly approved targeted therapy.
Intended use in the United States
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect D835 and I836 mutations in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates from patients diagnosed with acute myelogenous leukemia (AML).
The LeukoStrat CDx FLT3 Mutation Assay is used to aid in the evaluation of AML patients for whom RYDAPT® (midostaurin) treatment is being considered.
The LeukoStrat CDx FLT3 Mutation Assay is used to aid in the evaluation of AML patients for whom treatment with XOSPATA® (gilteritinib) is being considered.
The LeukoStrat CDx FLT3 Mutation Assay is used to aid in the evaluation of patients with AML FLT3-ITD for whom treatment with VANFLYTA® (quizartinib) is being considered.
The test is for use on the 3500xL Dx Genetic Analyzer.
"FDA approval of the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic to VANFLYTA is an important milestone for patients with newly diagnosed FLT3-ITD-positive AML," said Jeffrey Miller, Chief Strategy Officer, CEO and Founder of Invivoscribe. "Timely and accurate testing for FLT3-ITD mutations in newly diagnosed patients is critical to identifying those who may be eligible for treatment with VANFLYTA, and we are pleased to collaborate with Daiichi Sankyo to help bring this important new therapy to patients."
AML is a blood cancer that affects the blood and bone marrow and is characterized by the rapid growth of abnormal white blood cells.1 AML has the lowest 5-year survival rate (31.7%) among people diagnosed with leukemia.2 About 25% of AML patients have an FLT3-ITD mutation that contributes to the growth and survival of cancer cells and is associated with a poor prognosis.3
Previously, the LeukoStrat CDx FLT3 Mutation Assay was approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for use as an add-on diagnostic to select VANFLYTA-eligible FLT3-ITD-positive AML patients in Japan.
About Invivoscribe Invivoscribe is a global, vertically integrated biotechnology company dedicated to improving lives with Precision Diagnostics®. For nearly thirty years, Invivoscribe has improved the quality of healthcare around the world by providing high-quality, standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful history of partnering with global pharmaceutical companies interested in developing and commercializing companion diagnostics, and provides expertise in laboratory and regulatory services. By providing distributable kits as well as clinical trial services through its globally located clinical laboratory subsidiaries (LabPMM), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization. For additional information, please visit www.invivoscribe.com or contact us at inquiry@invivoscribe.com and follow us on LinkedIn.
1 https://www.cancer.net/cancer-types/leukemia-acute-myeloid-aml/introduction 2 https://seer.cancer.gov/statfacts/html/a... 3 Daver N et al. Leukemia (2019) 33:299–312.
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