COMPANY:

Invivoscribe Techno

"Invivoscribe is excited to announce that their CE-2797 IVD certified LeukoStrat CDx FLT3 Mutation Assay has been approved by BSI (Netherlands) and the EMA to aid in the selection of individuals in the European Union and European Economic Area with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo’s VANFLYTA (quizartinib)...In regions where XOSPATA (gilteritinib fumarate) is available, the LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA (gilteritinib fumarate) treatment is being considered...In regions where VANFLYTA (quizartinib hydrochloride) is available, the LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with FLT3-ITD+ AML for whom VANFLYTA (quizartinib hydrochloride) treatment is being considered."

"On July 20, 2023, the Food and Drug Administration approved quizartinib (Vanflyta, Daiichi Sankyo, Inc.) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test...FDA also approved LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Vanflyta."

"Invivoscribe and Complete Genomics announced today that they had entered a partnership to develop and commercialize biomarker tests on Complete Genomics' NGS platforms. The territory is worldwide, and the field is oncology and cancer research. Under the terms of the deal, Invivoscribe will be responsible for the development of biomarker tests, including test controls and associated bioinformatics software....Long-term plans include expansion of the relationship into clinical studies and regulatory submissions worldwide to support commercialization of in vitro diagnostic (IVD) testing products."

"'Today we are pleased to announce that Invivoscribe’s LeukoStrat® CDx FLT3 Mutation Assay has been approved by BSI (Netherlands) and the EMA as a Class C CDx assay, meeting the stringent new IVDR (Regulation (EU) 2017/746) requirements. Invivoscribe is one of the first companies in the world to gain an IVDR approval of a CDx assay. IVDR is a set of regulations that came into effect on May 26, 2022 that were put in place by the Europe Union (EU) to ensure the safety, traceability, quality and performance of in-vitro diagnostic medical devices (IVDs),' says Jason Gerhold, Global Director of Regulatory, Quality, and Clinical Affairs at Invivoscribe."

"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."