KUALA LUMPUR, Nov 28 (Bernama) -- In support of an ongoing partnership with Daiichi Sankyo, Invivoscribe submitted the LeukoStrat® CDx FLT3 Mutation Assay to both the US FDA and the Japan Pharmaceuticals and Medical Devices Agency (PMDA).
The submission was as the companion diagnostic for quizartinib, which follows Daiichi Sankyo’s respective FDA and PMDA applications for quizartinib in the US and in Japan, according to a statement.
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 partnership is bridge to the global phase 3 QuANTUM-R clinical trial (Europe, United States, Asia excluding Japan) in patients with relapsed/refractory FLT3 ITD AML.
Astellas and Invivoscribe have also submitted applications for the drug and device to the CDER and CDRH, respectively, in the United States.
The milestone also established the LeukoStrat CDx FLT3 Mutation Assay as the international gold standard for comprehensive FLT3 assessment for critically ill acute myeloid leukemia patients as this CDx is available worldwide and generates standardized signal ratios for both ITD and TKD mutations.
These criteria are already resulting in more consistent stratification of patients which will 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.
Invivoscribe, a privately held biotechnology company 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 at www.invivoscribe.com
-- BERNAMA
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