Invivoscribe is pleased to announce that their LeukoStrat(R) CDx FLT3 Mutation Assay was submitted to regulatory authorities in China in April in support of the Astellas New Drug Application (NDA) submission of XOSPATA(R) (gilteritinib) for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation. Invivoscribe also announced expansion of its wholly-owned company, Invivoscribe Diagnostic Technologies (Shanghai) Co. Ltd., adding laboratory testing services to support clinical trials and pharmaceutical partners.
Invivoscribe developed the LeukoStrat CDx FLT3 Mutation Assay in partnership with Astellas as the companion diagnostic supporting use of gilteritinib to treat adult patients with relapsed/ refractory FLT3-mutated AML.
"This is an announcement of two significant milestones: Submission of our LeukoStrat CDx Assay to the NMPA, and the expansion of our laboratory network into China. The submission itself is a milestone that builds on the LeukoStrat(R) CDx FLT3 Mutation Assay as the international gold standard signal ratio assay for comprehensive assessment of activating mutations in the FLT3 gene; one of the most important biomarkers in AML", said Jeffrey Miller, Invivoscribe's CSO and CEO. "Further, the expansion of our company to include a laboratory was done to provide comprehensive test support for our partners conducting trials in China. Testing will include simultaneous assessment of minimal residual disease by both flow cytometry and next-generation sequencing technologies conducted on exactly the same subject specimen. These paired analyses have been requested by regulatory authorities and partners, but have been missing in clinical studies. Invivoscribe's LabPMM laboratories will bring this long-desired capability to fruition in our laboratories in China, Japan, Europe, and the US."
The LeukoStrat CDx FLT3 Mutation Assay is the only internationally standardized signal ratio assay that identifies both ITD and TKD mutations of the FLT3 biomarker. It has been approved as a companion diagnostic by regulatory authorities in the US, Australia, and Japan, and is available as a CE-marked kit in Europe and Switzerland. The LeukoStrat(R) CDx FLT3 Mutation Assay served as the companion diagnostic in the ADMIRAL, RATIFY and QuANTUM-R clinical trials, which supported approvals of gilteritinib (XOSPATA(R)), midostaurin (RYDAPT(R)) and quizartinib (VANFLYTA(R)). The assay is available both as a service and as a kit. LeukoStrat CDx FLT3 Mutation Assay test services are available from LabPMM locations in Japan, Germany, and the United States.
About Invivoscribe
Invivoscribe has focused on Improving Lives with Precision Diagnostics(R) for more than twenty-five years, advancing the field of precision medicine by developing and selling standardized reagents, tests, and bioinformatics tools to more than 700 customers in 160 countries. Invivoscribe also has a significant impact on global health working with pharmaceutical companies to accelerate approvals of new drugs and treatments by supporting international clinical trials, developing, commercializing companion diagnostics, and providing expertise in both regulatory and laboratory services. With its proven ability to provide global access to distributable reagents, kits, and controls, as well as clinical trial services through our international clinical lab subsidiaries (LabPMM), Invivoscribe has demonstrated it is an ideal partner. For additional information please contact Invivoscribe at: [email protected] or visit: www.invivoscribe.com.
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Invivoscribe is excited to announce that the LeukoStrat(R) CDx FLT3 Mutation Assay has been approved by the U.S. 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 to receive treatment with Daiichi Sankyo's VANFLYTA(R) (quizartinib). The LeukoStrat CDx FLT3 Mutation Assay identifies FLT3 -ITD positive AML patients who may be treated with this newly approved targeted therapy. US Intended