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Invivoscribe Submits Regulatory Applications in Japan, US for AML CDx

NEW YORK (GenomeWeb) – Invivoscribe Technologies announced today that it has submitted a pre-market approval application with Japan's Pharmaceutical and Medical Devices Agency, as well as a panel track supplement to the US Food and Drug Administration for its LeukoStrat CDx FLT3 Mutation assay.

In collaboration with Astellas Pharma, Invivoscribe has developed the LeukoStrat CDx FLT3 Mutation assay, which helps identify genetic errors in the FLT3 gene in AML patients. The assay — approved by the US FDA in April 2017 — is a PCR-based in vitro diagnostic test designed to detect internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.

Invivoscribe's panel track supplement submission to the FDA is to update the intended use for the assay, specific for Astellas' gilteritinib, if it is approved. The 2017 FDA approval for the assay is for its use as a CDx with Novartis' drug Rydapt (midostaurin).

Invivoscribe submitted the forms based on Astellas' Phase III CL-0301 ADMIRAL study evaluating gilteritinib for treating FLT3 mutation-positive relapsed or refractory myeloid leukemia in adult patients.

The submissions represent a "significant step in our ongoing efforts to harmonize molecular diagnostic testing for what is one of the most important driver mutations in AML in support of precision medicine," Invivoscribe CEO and CSO Jeffrey Miller said in a statement.

Invivoscribe previously released a CE-marked IVD version of its FLT3 assay in August.