COMPANY:

Invivoscribe Techno

"Just launched! Invivoscribe’s FLT3 ITD MRD Assay for Acute Myeloid Leukemia (AML)...The FLT3 ITD MRD Assay is a targeted, deep-sequencing assay to identify internal tandem duplications (ITD), the most common mutation of the FLT3 gene. Unlike flow cytometry assays which require fresh sample and are highly subjective, this assay is designed for use with previously isolated DNA for scalable sample batching and an automated Linux-based software, circumventing the need for costly in-house bioinformatics expertise."

"Invivoscribe announced that its Shanghai lab in China has received CAP accreditation...The College of American Pathologists (CAP) is a professional organization that accredits clinical laboratories across the world. The CAP accreditation process is designed to ensure that laboratories meet or exceed the highest quality management system standards specific to patient testing."

"We are excited to announce that Invivoscribe has expanded its FLT3 portfolio to include an in-house end-to-end Research Use Only kit for Acute Myeloid Leukemia (AML) measurable residual disease (MRD) research...The FLT3 ITD MRD MRD Assay is a targeted, deep-sequencing assay identify internal tandem duplications (ITD), the most common mutation of the FLT3 gene. Unlike flow cytometry assays which require fresh sample and are highly subjective, this assay is designed for use with previously isolated DNA for scalable sample batching and an automated Linux-based software, circumventing the need for costly in-house bioinformatics expertise."

"Invivoscribe is pleased to announce that they have filed a supplemental Pre-Market Approval (sPMA) submission with the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) for the use of the LeukoStrat^® CDx FLT3 Mutation Assay as the companion diagnostic for Daiichi Sankyo's investigational drug quizartinib. The assay is used for the identification of newly diagnosed acute myeloid leukemia (AML) patients that have the FLT3-ITD mutation....The filing supports Daiichi Sankyo's new drug application (NDA) for quizartinib for the proposed treatment of adult patients with newly diagnosed FLT3-ITD positive AML, which was granted Priority Review by the FDA."

"Kronos Bio...and Invivoscribe, a global provider of diagnostic kits and services for oncology, today announced their agreement to develop a companion diagnostic (CDx) for use with Kronos Bio's investigational therapy, entospletinib....The diagnostic will screen for the NPM1 mutation, which is present in approximately one-third of all patients with AML....Entospletinib is currently being studied in the Phase 3 AGILITY registrational study, with data anticipated in second half of 2023."

"Hitachi High-Tech and Invivoscribe on Monday announced a partnership to combine their expertise and technologies to develop molecular diagnostics to diagnose cancer and monitor disease during treatment."

"Invivoscribe, Inc...today announced licensing of key software and two new MRD clinical services...Invivoscribe’s new pipeline LymphoTrack® Enterprise Software enables high volume customers to meet ever increasing testing demands."

"Invivoscribe. Inc...announced today a key submission in the EU, and expanded presence and activity in China...In these rapidly evolving times, Invivoscribe, Inc. is poised to continue as a leading provider of oncology precision diagnostics, in the EU and globally, as demonstrated with the June submission of the LeukoStrat® CDx FLT3 Mutation Assay to BSI...Invivoscribe’s IVDR companion diagnostic submission rapidly follows substantial milestones with this same CDx in China."

"Invivoscribe...has announced the launch of an Immune Biomarker Discovery grant program, focused on supporting development, validation and deployment of novel applications for use of their distributed LymphoTrack® NGS products and bioinformatics software."

“Invivoscribe, Inc…announces the launch of a fully integrated drug development engine. This new engine will combine with its in-house expertise in diagnostics development and worldwide access to patients and clinical testing capabilities to accelerate drug development.”