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This article has been updated from a previous version to include information about Japanese reimbursement for Invivoscribe's assay.

NEW YORK (GenomeWeb) – The US Food and Drug Administration said on Wednesday that it has approved an expanded indication for Invivoscribe Technologies' LeukoStrat CDx FLT3 Mutation Assay.

Specifically, FDA expanded approval for LeukoStrat for use with Xospata (gilteritinib), an Astellas Pharma drug for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia with a FLT3 mutation.

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Oct
09
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.