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Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United StatesSAN DIEGO, May 19, 2020 /CNW/ -- Invivoscribe to offer the LeukoStrat® CDx FLT3 Mutation Assay as an FDA approved kit with analysis software. In 2017, Invivoscribe's LeukoStrat® CDx FLT3 Mutation Assay became the first FDA approved FLT3 test and launched as a testing service at LabPMM, Invivoscribe's clinical laboratory in San Diego. This PMA supplement approval by the FDA provides customers a choice to purchase the IVD-labeled LeukoStrat® CDx FLT3 Mutation Assay kits for in-house testing. The ability to perform efficient, accurate, and objective FLT3 testing at regional laboratories, cancer treatment centers, and hospitals is expected to improve the management of patients diagnosed with acute myelogenous leukemia (AML). As the companion diagnostic to midostaurin (US, EU, Switzerland, Australia), gilteritinib fumarate (US, JP, EU), and quizartinib hydrochloride (JP), the LeukoStrat CDx is the only globally standardized FLT3 mutation test validated to meet international regulatory standards for detection of genetic mutations in the FLT3 gene, which is one of the most important driver mutations in AML. The LeukoStrat® CDx FLT3 Mutation Assay may be used a an aid in assessment of AML patients for treatment with approved FLT3 targeted therapies. "The release of the IVD-labeled kit will benefit patients afflicted with AML and is a critical tool for healthcare providers to identify the most appropriate treatment for newly diagnosed or relapsed/refractory FLT3mut+ AML patients," said Jeffrey Miller, Invivoscribe CSO and CEO. US Intended Use The LeukoStrat® CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom RYDAPT® (midostaurin) treatment is being considered. The LeukoStrat® CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA® (gilteritinib) treatment is being considered. The test is for use on the 3500xL Dx Genetic Analyzer. About Invivoscribe
View original content to download multimedia:http://www.prnewswire.com/news-releases/invivoscribe-announces-fda-approval-for-distribution-of-the-leukostrat-cdx-flt3-mutation-assay-as-an-ivd-kit-in-the-united-states-301061353.html SOURCE Invivoscribe, Inc. |