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Invivoscribe Submits Biomarker Test for Astellas Cancer Drug to China's NMPA

publication date: May 12, 2020

Invivoscribe, a San Diego precision medicine company, has submitted its FLT3 mutation assay to China's NMPA as part of Astellas' NDA for Xospata® (gilteritinib), a treatment for acute myeloid leukemia. Invivoscribe developed the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic supporting use of gilteritinib to treat adult patients with relapsed/refractory FLT3-mutated AML. The assay is approved in the US, the EU, Australia and Japan. Invivoscribe has also opened a Shanghai lab to provide laboratory testing services for clinical trials and pharmaceutical partners. More details....

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