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The firm has received a supplemental approval that provides its customers with an option to purchase its IVD-labeled FLT3 mutation assay for in-house testing.
The study, presented at the American Society of Hematology meeting, also suggested that a moleculary guided strategy may lead to better outcomes than standard of care.
The LeukoStrat CDx FLT3 Mutation Assay can now be used in Japan as the CDx for quizartinib for the treatment of FLT3-ITD positive relapsed or refractory AML.
Results from the phase 3 ADMIRAL trial were announced during the American Association for Cancer Research annual meeting.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based test for internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.
Invivoscribe submitted the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.
The company submitted the test to Japanese regulators for approval as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.
The firm expects to begin distributing shipments of its FTL3 assay from LabPMM GK, the marketing authorization holder in Japan, in late 2018.
The firm's LeukoStrat CDx FLT3 Mutation Assay detects internal tandem duplications and tyrosine kinase domain mutations in patients with acute myeloid leukemia.
The US has sent its formal notice of withdrawal from the World Health Organization, according to the Wall Street Journal.
Science reports that a draft spending bill would increase the US National Institutes of Health budget by 13 percent.
The Harvard Crimson reports that Harvard and MIT are suing the Department of Homeland Security and ICE over the new international student visa policy.
In Nucleic Acids Research this week: algorithm to determine molecular sequence types and other microbial features, computational method to uncover R-loop structures, and more.