KUALA LUMPUR, Nov 21 (Bernama) -- Invivoscribe Inc -- a privately held biotechnology company -- has submitted the LeukoStrat CDx FLT3 Mutation Assay to the Pharmaceuticals and Medical Devices Agency (PMDA) as the companion diagnostic for quizartinib, following Daiichi Sankyo’s PMDA application for quizartinib in Japan.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based, in vitro diagnostic test designed to detect 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 acute myelogenous leukemia.
The submission complements Invivoscribe’s prior regulatory approvals of the LeukoStrat CDx FLT3 Mutation Assay as an acute myeloid leukemia (AML) companion diagnostic in support of midostaurin for Novartis (United States and Europe) and gilteritinib fumarate for Astellas (Japan).
The milestone helps to further establish the LeukoStrat CDx FLT3 Mutation Assay as the international standard for comprehensive FLT3 assessment for critically ill AML patients as this CDx is available worldwide and generates standardized signal ratios for both ITD and TKD mutations.
These criteria resulting more consistent stratification of patients to help prescribing doctors identify personalized therapy options for their patients and accelerate new drug and therapy approvals by establishing more homogeneous patient populations for clinical trials.
The company has developed the LeukoStrat CDx FLT3 Mutation Assay in partnership with Daiichi Sankyo as the companion diagnostic that bridges to the global phase 3 QuANTUM-R clinical trial in patients with relapsed and refractory FLT3 ITD AML.
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. More details on www.invivoscribe.com.
-- BERNAMA
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