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Invivoscribe Submits FLT3 Mutation Assay CDx to Japanese Regulators

NEW YORK (GenomeWeb) — Invivoscribe announced today that it has submitted its LeukoStrat CDx FLT3 Mutation Assay to Japanese regulators as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.

The test is designed to detect internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene, and was approved by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in September to predict patient response to Astellas Pharma's AML drug Xospata (gilteritinib).

According to San Diego-based Invivoscribe, the test's submission as a companion diagnostic to quizartinib follows Daiichi Sankyo's recent submission of the drug to the PMDA for the treatment of adult patients with relapsed/refractory FLT3-internal tandem duplication AML.

"We continue to welcome opportunities to partner with global pharmaceutical companies interested in developing and commercializing companion diagnostics, whether for hematologic disease or solid tumors," Invivoscribe CEO and CSO Jeffrey Miller said in a statement.

Last year, the US Food and Drug Administration approved Novartis' AML treatment Rydapt (midostaurin) in combination with chemotherapy alongside the LeukoStrat CDx FLT3 Mutation assay. The assay has also been submitted to US regulators as a companion diagnostic to Astellas' Xospata.