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Japanese Regulators Approve Invivoscribe Assay as CDx for Daiichi Sankyo AML Drug

NEW YORK (GenomeWeb) – Invivoscribe announced today that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved the firm's LeukoStrat CDx FLT3 Mutation Assay as the companion diagnostic for Daiichi Sankyo's quizartinib for the treatment of FLT3-ITD positive relapsed or refractory acute myeloid leukemia (AML) patients.

The PCR-based IVD LeukoStrat assay detects internal tandem duplication mutations and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with AML. The test also includes data interpretation software, generates standardized mutant-to-wildtype signal ratios for ITD and TKD mutations, and predicts response to multiple tyrosine kinase inhibitors, Invivoscribe said.

"Once again, our Streamlined CDx program has demonstrated its effectiveness in accelerating submissions and approvals for our partners worldwide," Invivoscribe CEO and CSO Jeffrey Miller said in a statement. "Invivoscribe welcomes opportunities to partner with global pharmaceutical companies interested in developing and commercializing companion diagnostics, whether their therapies are targeting hematologic diseases or solid tumors."

The Japanese MHLW also approved the use of EDTA collection tubes for this assay. Heparin collection tubes had been previously approved, the company noted.

In November, the firm announced that the US Food and Drug Administration approved an expanded indication for the LeukoStrat assay for use with Astellas Pharma's gilteritinib (Xospata), a treatment for adult patients who have relapsed or refractory AML with an FLT3 mutation.

The assay has also received approval in Japan for predicting patient response to Xospata and has been cleared in the US and Europe as a companion diagnostic to Novartis' AML treatment midostaurin (Rydapt).

Invivoscribe has submitted the assay to the FDA as a CDx for quizartinib, and said in November that the MHLW has confirmed national reimbursement for the LeukoStrat assay.