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OGT first to achieve IVDR-certification for FISH probes
Company demonstrates complete readiness for new EU IVDR and continued confidence in its safe, reliable, high-quality products
A Sysmex Group Company, announces that IVDR-certification has been granted for eight CytoCell® fluorescence in situhybridisation (FISH) probes important for patient management in haematological cancers and prenatal conditions. This award places OGT as the first manufacturer of FISH probes to obtain the new IVDR certification on its products—demonstrating continued safety, reliability and effectiveness under this substantially more stringent regulation.
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) replaced Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) on 26th May 2022. From this date, any new IVD products placed on the EU market must comply with the IVDR.
To avoid the anticipated backlog of IVDR conformity assessments, OGT committed early to IVDR and began discussions with a notified body, BSI, back in 2019. Since then, OGT has been working tirelessly to be 100% IVDR-ready and to meet conformity requirements under the regulation. This encompasses not just the safety and performance of its products, but also facilities, manufacturing systems, supply chain, quality management system (QMS) and more. The culmination of this work has led to the certification of its first tranche of eight existing FISH probes as Class C devices under the IVDR, with further products to follow.
The IVDR certification means that customers can be confident in the continued quality, safety and performance of OGTs products and manufacturing processes. Being IVDR-compliant and already having products certified will also help to future-proof customer supply chains – adoption of OGT’s products will avoid the need to change suppliers and revalidate if IVDR products are not available from other companies.
Steve Chatters, Executive Vice President of Regulatory, Medical and Quality Affairs at OGT commented, “IVDR is all about patient safety and effectiveness, and at OGT, we’re really committed to compliance with changing worldwide regulations and providing products that meet these needs, for clinicians and patients alike. We have a great team that got us ahead of the game and in a rare position of not only being 100% IVDR-ready, but gaining certification for our first set of CytoCell FISH probes. This demonstrates that OGT means what it says and that our products live up to the claims. Our IVDR FISH probes are still the same trusted products that we’ve always had—the certification has further validated our quality, safety and effectiveness. These are products and a company you can depend on.”
Adrian Smith, CEO of OGT also noted, “I’m incredibly proud that OGT is the first FISH probe manufacturer to bring its probes to market under the new IVD Regulation. Gaining IVDR certification is a challenging process. This achievement is a testament to the clinical efficacy and safety of our products, the dedication of our people and our unwavering commitment to quality.”
OGT is in the final stages of commercialisation, with launch anticipated in early 2023. For further information, or to receive notification when the IVDR-certified probes are available, please register on the OGT website.
OGT, a Sysmex Group company, is a leading global provider of clinical and diagnostic genomic solutions that are created for scientists by scientists - including CytoCell®, CytoSure® and SureSeq™ ranges of FISH, microarray and NGS products. The company is dedicated to creating products that enable researchers and clinical decision makers to reach the right care decisions for each patient, every time. OGT strives to unlock the future of genetic clinical care with a commitment to working in partnership with its customers - not only by sharing its expertise of 25 years at the forefront of genetic endeavour, but also by working closely with scientists to understand their unique challenges, and to customise its approach to meet their exact needs. Dedicated to improving clinical care, OGT believes that through partnership—together—we’ll achieve more.
CytoSure®, SureSeq™ and myProbes®: For Research Use Only, not for use in diagnostic procedures. CytoCell®: Some products may not be available in your region.
Sysmex Corporation is a world leader in clinical laboratory systemization and solutions, including laboratory diagnostics, laboratory automation and clinical information systems. Serving customers for more than 50 years, Sysmex focuses on technological leadership in diagnostic science and information tools that make a difference in the health of people worldwide. The company is also exploring emerging opportunities in the life science field. Its R&D efforts focus on the development of high-value-added testing and diagnostic technologies that are innovative, original and optimize individual health. Sysmex also seeks to leverage its state-of-the-art technologies for cell, gene and protein analysis. The company, headquartered in Kobe, Japan, has subsidiaries in North America, Latin America, Europe, the Middle East, Africa, China and Asia Pacific and employs more than 10,000 employees worldwide. Sysmex Corporation is listed in the top tier of the Tokyo Stock Exchange.