CA-INVIVOSCRIBE
22.7.2021 19:19:07 CEST | Business Wire | Press release
Invivoscribe, Inc., an industry pioneer in developing and commercializing diagnostic products and reagents for hematological malignancies, announced today a key submission in the EU, and expanded presence and activity in China.
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).
About Invivoscribe
Invivoscribe has been Improving Lives with Precision Diagnostics® for more than twenty-five years, advancing the field of precision medicine by developing and selling standardized reagents, tests, and bioinformatics tools to more than 700 customers in 160 countries. Invivoscribe also has a significant impact on global health working with pharmaceutical companies to accelerate approvals of new drugs and treatments by supporting international clinical trials, developing, commercializing companion diagnostics, and providing expertise in both regulatory and laboratory services. With its proven ability to provide global access to distributable reagents, kits, and controls, as well as clinical trial services through our international clinical lab subsidiaries (LabPMM), Invivoscribe has demonstrated it is an ideal partner. For additional information please visit: www.invivoscribe.com or contact Invivoscribe at: customerservice@invivoscribe.com .
View source version on businesswire.com: https://www.businesswire.com/news/home/20210722005162/en/
Link:
Social Media:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
AS Graanul Invest Appoints Energy Industry Veteran Lars Christian Bacher as Chief Executive Officer14.5.2026 14:45:00 CEST | Press release
ASGraanul Invest (“Graanul” or the “Company”), Europe’s largest producer of sustainable wood pellets used for electricity and heat production, today announces energy industry veteran Lars Christian Bacher will be joining the business as Chief Executive Officer, effective 18 May. Bacher will drive the Company’s growth across Europe as Graanul doubles down on its strategy to provide its customers with sustainable fuel to enable the production of renewable, dispatchable power and heat. Outgoing Chief Executive Nicholas Dottino will support Bacher with his transition to his new role as an advisor to Apollo on infrastructure and energy investments. Bacher joins Graanul having previously worked at Norwegian multinational energy company Equinor as a member of the Executive Committee for over eight years, including two years as Chief Financial Officer, where he had responsibility for managing financial operations and strategic planning. Prior to this, he was executive Vice President, Developme
Mobix Labs to Acquire U.S. Rare Earth and Critical Minerals Company Powering Defense and National Security14.5.2026 14:01:00 CEST | Press release
Proposed Acquisition Would Position Mobix Labs Inside Strategic U.S. Supply Chains Powering Defense, National Security, and AI Infrastructure Mobix Labs, Inc. (Nasdaq: MOBX) today announced it has signed a non-binding Letter of Intent to acquire Special Project Delivery LLC ("SPD"), a strategic infrastructure platform building sovereign U.S. supply chains for rare earth elements, critical minerals, and energy storage. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514342224/en/ U.S.A F-35 Lightning II The proposed acquisition would expand Mobix Labs — already a supplier to advanced U.S. and allied defense and aerospace systems — directly into one of the world's most strategically important industrial sectors. Key Facts at a Glance~418 kilogramsof rare earth materials are estimated to be used in each F-35 Lightning II. ~4,500 kilogramsof rare earth materials are estimated to be used in each Virginia-class nuclear submarine
Enterprise AI Hits the Wall: NTT DATA Research Reveals Growing Privacy and Sovereignty Barriers14.5.2026 14:00:00 CEST | Press release
Demands for privacy and sovereignty expose limits of architectures built for centralized and borderless data flows. Data jurisdiction has become a core design parameter, shifting away from globally integrated systems to regionally bounded architectures. Organizations that redesign early are gaining a measurable edge in AI readiness and scale. NTT DATA, a global leader in AI, digital business and technology services, today released new research showing that enterprise AI is outgrowing the architecture and infrastructure beneath it as data privacy and sovereignty requirements tighten. The research finds a widening split between enterprises that are redesigning AI for control, locality and security, and organizations still layering AI into environments that were not built to support these requirements. For years, enterprise architecture moved data across systems, clouds, applications and borders with increasing speed and efficiency. AI is exposing the limits of that model. Sensitive data
Mary Kay Launches Global Social Squad Program to Empower the Next Generation of Digital Beauty Leaders14.5.2026 14:00:00 CEST | Press release
A Global Program Connecting 70+ Emerging Creators Among Independent Beauty Consultants with Digital Education, Mentorship, And Real‑World Beauty Brand Experience. Mary Kay Inc., a global leader in beauty and entrepreneurship, announces the launch of its Global Social Squad (GSS) Pilot Program – a groundbreaking initiative designed to empower Mary Kay Independent Beauty Consultants (IBCs) as dynamic digital brand advocates and next-generation social media storytellers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514978222/en/ The Global Social Squad ignites a diverse and talented group of 73 Mary Kay Independent Beauty Consultants with representation across 15 markets in four regions: North America, Asia Pacific, Latin America, and Europe. These digital leaders create engaging, high-quality content, participate in global campaign activations, and share practical social media strategies with their communities and other I
Vista Equity Partners Establishes Abu Dhabi Office14.5.2026 14:00:00 CEST | Press release
Securing Full Regulatory Authorization from ADGM deepens Vista’s commitment to the Middle East and expands the firm’s global platform for enterprise software investing Vista Equity Partners (“Vista”), a global technology investor that specializes in enterprise software, today announced the opening of its new office in Abu Dhabi within ADGM, the city’s international financial center. VEPM Middle East Limited has received full authorization from ADGM’s Financial Services Regulatory Authority (FSRA), enabling the firm to advise on investments and arrange deals in investments across the region. The Abu Dhabi office reflects Vista’s expanded strategic presence in the Middle East and the region’s increasingly central role in global technology investment and innovation. Established in 2013, ADGM has emerged as one of the world’s leading financial centers, connecting global investors with regional opportunities. Vista joins a growing community of leading global investment firms that have estab
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom