The firm is providing the assay as a kit for purchase and as a testing service. Credit: Tatiana from Pixabay.

Biotechnology company Invivoscribe has secured updated reimbursement from Japan’s Ministry of Health, Labor and Welfare (MHLW) for its LeukoStrat CDx FLT3 mutation assay.

The expanded reimbursement for the assay is intended to identify patients with newly diagnosed FLT3-ITD positive acute myeloid leukaemia (AML) who may be eligible for treatment with Daiichi Sankyo’s VANFLYTA(quizartinib).

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Invivoscribe is offering the assay globally as a kit for purchase, and as a testing service.

In June 2019, the company received Japanese approval for this assay as a companion diagnostic for relapsed or refractory FLT3-ITD positive AML.

Starting 25 May 2023, reimbursement under health insurance will also cover the LeukoStrat CDx FLT3 mutation assay to identify newly diagnosed FLT3-ITD positive patients in Japan.

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Invivoscribe CEO and CSO Jeffrey Miller said: “We are proud to be Daiichi Sankyo’s companion diagnostic partner as they offer the first FLT3 inhibitor approved as a de novo treatment option for patients with FLT3-ITD positive AML in Japan.

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“This milestone demonstrates the utility of using the LeukoStrat CDx FLT3 Mutation Assay in international clinical trials, as well as Invivoscribe’s focus on providing standardised diagnostic tests to improve the lives of cancer patients.”

Invivoscribe has received expanded insurance reimbursement for the test based on a pivotal clinical bridging trial.

The study demonstrated that the LeukoStrat CDx assay used for patient selection maintained efficacy and showed concordance when compared to the FLT3-ITD Clinical Trial Assay (CTA) in the pivotal QuANTUM-First trial.

Last week, VANFLYTA was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of FLT3-ITD positive AML.

The approval was based on the pivotal QuANTUM-First trial.