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Invivoscribe Submits FLT3 Mutation CDx Assay to FDA

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

The PCR-based test is designed to detect internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene, and is already cleared in the US and Europe as a companion diagnostic to Novartis' AML treatment Rydapt (midostaurin) and in Japan for predicting patient response to Astellas Pharma's AML drug Xospata (gilteritinib).

Tokyo-based Daiichi recently submitted quizartinib to both Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and the FDA, and earlier this month San Diego-based Invivoscribe submitted the test to the PMDA as a companion diagnostic for the drug. The assay has also been submitted to the FDA as a Xospata companion diagnostic.

"These LeukoStrat CDx FLT3 Mutation Assay submissions and continuing Daiichi Sankyo partnership represent significant milestones for our company," Invivoscribe CEO and CSO Jeffrey Miller said in a statement. "We welcome opportunities to partner with global pharmaceutical companies interested in developing and commercializing companion diagnostics, whether their therapies are targeting hematologic diseases or solid tumors."