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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 Food and Drug Administration is to announce stricter standards for emergency authorizations of SARS-CoV-2 vaccines, reports the Washington Post.
The Associated Press reports Johnson & Johnson is starting a late-stage clinical trial of its candidate SARS-CoV-2 vaccine.
Bloomberg reports the budget of Operation Warp Speed is actually $18 billion, higher than the number typically cited.
In Genome Research this week: genomic analysis reveals role of super-spreaders in SARS-CoV-2, epigenetic drivers of cancer, and more.