On July 22, 2021 Invivoscribe. Inc., an industry pioneer in developing and commercializing diagnostic products and reagents for hematological malignancies, reported a key submission in the EU, and expanded presence and activity in China (Press release, Invivoscribe Technologies, JUL 22, 2021, View Source [SID1234585089]).
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As of May 26, 2022 IVDs in the EU must be certified per the new in vitro diagnostic regulations (IVDR (2017/746)) prior to being put on the market. Further, all on-market IVDs will require submission to IVDR qualified notified bodies in Europe. As a leading diagnostic company, Invivoscribe, Inc. has demonstrated their preparedness via their early submission to BSI (Netherlands) and has planned and set the stage for further IVDR submissions. 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.
Tony Lialin, Chief Commercial Officer at Invivoscribe shared, "In being one of the first to submit we are quick to develop a relationship with our notified body and master the IVDR regulatory guidelines, which are expected to expedite submission of all our assays. As an early player, submission requirements were still being finalized by BSI in parallel to Invivoscribe generating the Class C companion diagnostic submission package, demonstrating our strength in pivoting to meet changing regulatory requirements." He adds, "Our early submission and additional packages in preparation help ensure there will be no interruption in test coverage for EU patient populations."
Invivoscribe’s IVDR companion diagnostic submission rapidly follows substantial milestones with this same CDx in China. The LeukoStrat CDx FLT3 Mutation Assay was used to select patients in a Phase III drug trial resulting in the NMPA/CDE February 2021 conditional approval of the Astellas drug gilteritinib fumarate used to treat R/R FLT3+ AML patients. This assay is under evaluation at 3 AAA hospitals and is currently available as a clinical research service at Invivoscribe’s Shanghai-based laboratory. Invivoscribe Diagnostic Technologies (Shanghai) Co., Ltd. has recently expanded their presence as a China based CRO by constructing a lab that is offering both molecular and flow cytometry testing services standardized with those available through the LabPMM network of clinical laboratories which have been serving our partners and customers in the USA, the EU, and Japan for some time.
With internationally standardized kits and services, custom assay development solutions, clinical trial management, regulatory expertise, and most recently expanding as a front runner for IVDR submissions in the EU while expanding capabilities in China, Invivoscribe is strategically positioned to provide comprehensive support to our global partners.
Intended Use
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).