SAN DIEGO, Oct. 24, 2022 /PRNewswire/ — Invivoscribe is happy to announce that they’ve 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. The assay is used for the identification of newly identified acute myeloid leukemia (AML) sufferers which have the FLT3-ITD mutation.
The submitting helps Daiichi Sankyo’s new drug software (NDA) for quizartinib for the proposed remedy of grownup sufferers with newly identified FLT3-ITD optimistic AML, which was granted Priority Review by the FDA. Previously, the LeukoStrat CDx FLT3 Mutation Assay was accepted by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for use as a companion diagnostic to choose relapsed and refractory AML sufferers 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,” stated Dr. Jeffrey Miller, Invivoscribe’s CSO and CEO.
Mutations in the FLT3 gene are amongst the most vital driver mutations in AML, with roughly one-third of all newly identified grownup instances containing FLT3 mutations. The FLT3 inside tandem duplication (ITD) mutation happens in about 25%, and the tyrosine kinase area (TKD) mutation happens in roughly 5% of all newly identified sufferers with AML.1
Invivoscribe’s companion diagnostic is an in vitro PCR check which detects each 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 sufferers identified with AML. This check, which is on the market worldwide, consists of software program that interprets knowledge, generates standardized mutant/wildtype sign ratios for ITD and TKD mutations, and predicts response to a number of tyrosine kinase inhibitors.
LeukoStrat CDx FLT3 Mutation Assay kits are at present distributed in Japan, the United States, Europe and China. The LeukoStrat CDx FLT3 Mutation Assay can be obtainable in Japan, Germany and the United States as a service via Invivoscribe’s wholly-owned LabPMM® subsidiaries. Greater than 95% of affected person samples examined utilizing the FDA-approved LeukoStrat CDx FLT3 Mutation Assay and a range of different CLIA-validated PCR-based capillary assays report out outcomes inside 48 hours of pattern receipt at any of the LabPMM laboratories.
Invivoscribe is a world, vertically-integrated biotechnology firm devoted to Improving Lives with Precision Diagnostics®. For practically thirty years, Invivoscribe has improved the high quality of healthcare worldwide by offering top quality, standardized reagents, assessments, and bioinformatics instruments to advance the subject of precision medication. Invivoscribe has a profitable monitor document of partnerships with international pharmaceutical corporations desirous about creating and commercializing companion diagnostics, and supplies experience in each regulatory and laboratory companies. Providing distributable kits, in addition to medical trial companies via its globally positioned medical lab subsidiaries (LabPMM), Invivoscribe is a perfect companion from diagnostic improvement, via medical trials, regulatory submissions, and commercialization. For extra info, please contact Invivoscribe at: [email protected] or comply with Invivoscribe on Linked In.
1 Kennedy VE, Smith CC. (2020) Front Oncol. 10:612880.
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