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Invivoscribe Submits Pre-Market Approval Application in Japan and Panel Track Supplement in the US to Screen Acute Myeloid Leukemia (AML) Patients for FLT3 Mutations

Invivoscribe Technologies, Inc. announced today that they have submitted to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) and the US Food and Drug Administration (FDA) product registrations based on the ongoing Phase III CL-0301 ADMIRAL study evaluating gilteritinib for the treatment of FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia (AML) in adult patients.
Invivoscribe Technologies Inc., in collaboration with Astellas Pharma Inc., has developed a companion diagnostic to aid in identifying these FLT3mut+ AML patients.  In Japan, Invivoscribe submitted a pre-market approval application (Shonin) with the PMDA for the LeukoStrat® CDx FLT3 Mutation Assay and in the United States, Invivoscribe submitted a Panel Track Supplement to update the FDA-approved LeukoStrat CDx FLT3 Mutation Assay’s Intended Use, specific for gilteritinib, should it be approved.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplications (ITD) and tyrosine kinase domain (TKD) 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. Invivoscribe was the first company to receive FDA approval for an AML companion diagnostic, with the approval of the LeukoStrat CDx FLT3 Mutation Assay in April of 2017.
“These submissions in Japan and the US 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,” said Jeffrey Miller, CSO & CEO of Invivoscribe.
According to the American Cancer Society, each year around 20,000 new cases of AML are diagnosed in the US alone, with one-third of these being FLT3mut+.
Invivoscribe Technologies Inc. is a privately held biotechnology company dedicated to improving the quality of healthcare worldwide by providing high quality, standardized reagents, tests, and bioinformatics tools to advance the fields of personalized molecular diagnostics and personalized molecular medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies developing and commercializing companion diagnostics.