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COMPANY:
Invivoscribe Techno

i
Other names: Invivoscribe, Inc. | Invivoscribe Therapeutics, Inc. | Invivoscribe, Inc | invivoscribe | Invivoscribe, SARL | Invivoscribe Diagnostic Technologies (Shanghai) Co., Ltd. | Invivoscribe Technologies | LabPMM | Genection | AML Alliance | Invivoscribe Technologies SARL | IVS. SARL | Invivoscribe Technologies, Inc. | Invivoscribe Technologies Inc. | Invivoscribe | Invivoscribe Technologies Inc. | Invivoscribe Technologies | Invivoscribe, Inc. (USA) | Invivoscribe Therapeutics, Inc. (USA) | Invivoscribe, SARL (France) | Invivoscribe Diagnostic Technologies, (Shanghai) Co., Ltd. | LabPMM, LLC (USA) | LabPMM, GmbH (Germany) | LabPMM, GK (Japan) | Invivoscribe Technologies Inc | Genection Inc. | Genection, Inc., | Genection, Inc., | Genection Inc | Genection, Inc. | Genection | AML Alliance. | InVivoScribe Technologies, SARL. | Invivoscribe SARL | Invivoscribe Technologies SARL | IVS SARL
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Evidence

News

9ms
FDA approves quizartinib for newly diagnosed acute myeloid leukemia (FDA)
"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."
Regulatory
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LeukoStrat® CDx FLT3 Mutation Assay
11ms
Invivoscribe Partners with Complete Genomics to Develop and Commercialize Biomarker Tests for Oncology and Cancer Research (PRNewswire)
"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."
Licensing / partnership
11ms
Invivoscribe announces IVDR approval of the LeukoStrat® CDx FLT3 Mutation Assay (Invivoscribe Press Release)
"'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."
European regulatory
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LeukoStrat® CDx FLT3 Mutation Assay
1year
New Invivoscribe FLT3 ITD MRD Assay (Abacus dx Press Release)
"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."
Launch
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FLT3 ITD MRD Assay
1year
Invivoscribe Diagnostic Technologies (Shanghai) Co. Ltd. receives CAP accreditation to support clinical research testing for pharmaceutical partners in China. (Invivoscribe Press Release)
"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."
Regulatory
over1year
New Invivoscribe FLT3 ITD MRD Assay for RUO (Bio-Connect)
"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."
Clinical
over1year
Invivoscribe files sPMA with the FDA for use of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with Newly Diagnosed FLT3-ITD Positive AML (Canada Newswire)
"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."
FDA event
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LeukoStrat® CDx FLT3 Mutation Assay
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Vanflyta (quizartinib)
over1year
Kronos Bio and Invivoscribe Partner on Companion Diagnostic for Use with Entospletinib, Kronos Bio’s Investigational Compound Being Developed for Patients with AML (PRNewswire)
"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."
Licensing / partnership • P3 data
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NPM1 Mutation Assay
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entospletinib (GS-9973)
almost2years
Hitachi High-Tech, Invivoscribe partner on cancer MDx development (Genomeweb)
"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."
Licensing / partnership