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Invivoscribe Receives FDA Approval for the LeukoStrat CDx FLT3 Mutation Assay Companion Diagnostic Test for the Selection of Patients for Rydapt and is the First Companion Diagnostic for AML

Invivoscribe® Technologies Inc., a global company with more than 20 years of experience providing clonality and biomarker test solutions for the fields of oncology, personalized molecular diagnostics® and personalized molecular medicine®, today announces the premarket approval of LeukoStrat® CDx FLT3 Mutation Assay. Due to current labeling for the FDA approved test, FLT3 mutation testing with LeukoStrat® CDx FLT3 Mutation Assay is exclusively performed by The Laboratory for Personalized Molecular Medicine, a subsidiary of Invivoscribe Technologies, Inc., which has gained FDA approval for its FLT3 test as a companion diagnostic for the Novartis drug Rydapt® in newly diagnosed FLT3+ AML.

Invivoscribe Expands Long-Term Collaboration Agreement to Release FLT3 Mutation and Clonality Assay Kits

Invivoscribe® Technologies Inc., a global company with more than 20 years of experience providing clonality and biomarker test solutions for the fields of oncology and personalized molecular diagnostics®, today announces the expansion of its long-term collaboration agreement with Thermo Fisher Scientific to include development and commercialization of in vitro diagnostic (IVD) assays for the Applied Biosystems® 3500 Dx Series Genetic Analyzers. The company’s previously announced agreement focuses on the development of IVD oncology tests for the Ion PGM™ Dx System.