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FDA submission

The guidance is meant to help provide the pharma industry, researchers, and IRBs with information to facilitate studies of oncology drugs for pediatric patients.

Invivoscribe submitted the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.

The company said it will seek FDA approval for the assay, an expanded version of FoundationACT, as a CDx for targeted therapies and as a tumor mutation profiling assay.