On May 12, 2020 Invivoscribe reported that their LeukoStrat 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 (gilteritinib) for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation (Press release, Invivoscribe Technologies, MAY 12, 2020, View Source [SID1234557639]). 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.
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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 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 CDx FLT3 Mutation Assay served as the companion diagnostic in the ADMIRAL, RATIFY and QuANTUM-R clinical trials, which supported approvals of gilteritinib (XOSPATA), midostaurin (RYDAPT) and quizartinib (VANFLYTA). 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.