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Invivoscribe Releases LeukoStrat CDx FLT3 Mutation Assay as CE-marked IVD Assay Kit

Invivoscribe® Technologies Inc., a global company with decades of experience providing clonality and biomarker test solutions for the fields of oncology and personalized molecular medicine®, today announces the release of the CE-marked IVD version of its LeukoStrat® CDx FLT3 Mutation Assay which earlier this year was approved by the FDA.

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 Business into Solid Tumors with Assays and Services to Identify and Monitor CAR-T and TCR Immuno-Therapies

Invivoscribe® Technologies Inc., a global company with decades of experience providing internationally standardized clonality and biomarker testing solutions for the fields of oncology, personalized molecular diagnostics®, and personalized molecular medicine®, reports that its next-generation sequencing (NGS) LymphoTrack® Assay kits are being used by its LabPMM® clinical laboratories, pharmaceutical partners, and cancer centers to identify and monitor chimeric antigen receptor T-cells (CAR-T) and engineered T-cell receptors in peripheral blood of subjects in support of immuno-therapeutic drug development and treatment regimen development for both hematologic and solid tumors.

Invivoscribe Expands Ion PGM NGS Platform Menu: Releases Additional CE-IVD Clonality Kits with Bioinformatics Software and RUO Kits with MRD Software

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 released three additional CE-marked next-generation sequencing (NGS) assay kits for in vitro diagnostic (IVD) use to assist in the diagnosis of B-cell malignancies. Invivoscribe has now commercialized more than 40 CE-IVD assays and bioinformatics packages for capillary electrophoresis and NGS platforms and has recently announced a long-term agreement with Thermo Fisher Scientific to bring regulated IVD assays through the FDA on the Ion PGM™ Dx System.

Invivoscribe Announces Long-Term Collaboration Agreement with Illumina and Plans Release of NGS-based IVD Assay Kits

Invivoscribe® Technologies Inc., an international company with decades of experience providing clonality and biomarker test solutions for the fields of oncology, personalized molecular diagnostics® and personalized molecular medicine®, announces today its long-term collaboration agreement with Illumina® Inc., to develop and commercialize in vitro diagnostic (IVD) assays for the next-generation sequencing (NGS) MiSeqDx® platform. This agreement allows Invivoscribe to bring IVD assays through the FDA, together with the associated bioinformatics software, for sale and distribution in the US.