OGT continues move into molecular diagnostics markets
Oxford, UK – 12 November 2019. Oxford Gene Technology (OGT), A Sysmex Group Company, is proud to announce that its new facility in Cambridge, UK, has achieved Medical Device Single Audit Program (MDSAP) certification of its quality management system (QMS). The announcement further solidifies the company’s aim to reach into molecular diagnostic markets following its first FDA clearance for eight Cytocell Aquarius® Haematology fluorescence in situ hybridisation (FISH) probes earlier this year.
Developed by the International Medical Device Regulators Forum (IMDRF), the MDSAP enables medical device manufacturers to fulfil the requirements of multiple participating regulatory authorities through a single QMS audit.
The certification from Lloyd’s Register (LR) is for the full MDSAP scope, which is based on ISO 13485:2016 with additional country-specific requirements for the US FDA, Health Canada, TGA (Australia), ANVISA (Brazil), MHLW and PMDA (Japan).
John Anson, OGT’s CEO said: “This is a major achievement for the company and clearly further demonstrates our commitment to quality on a global level. MDSAP is a challenging process and its achievement represents a huge team effort across all functions. It demonstrates to our customers that we are dedicated to providing the highest quality molecular diagnostic products and this certification will ultimately facilitate future IVD approvals - bringing these products to market faster.”
John Perkins, Cytocell’s QC/QA Manager, said: “MDSAP certification is yet another important milestone for us, following last year’s successful transition to the updated standards, ISO 9001:2015 and ISO 13485:2016. It demonstrates the strength of our quality system and our continued commitment to quality, in fact in October 2019 we will have held ISO certification continuously for 20 years.”
For further information, please contact:
Oxford Gene Technology, Begbroke Science Park, Begbroke Hill, Woodstock Road, Begbroke, Oxfordshire, OX5 1PF, U.K.
T: +44 (0) 1865 856826 ; F: +44 (0) 1865 848684
Notes for editors:
About Oxford Gene Technology
Oxford Gene Technology (OGT) provides world-class genetics research solutions to leading clinical and academic research institutions. Founded by Professor Sir Edwin Southern, and with customers in over 60 countries worldwide, OGT has a strong reputation and increasing share in the large and growing genomic medicine market. The Company’s Cytocell®, CytoSure™ and SureSeq™ range of fluorescence in situ hybridisation (FISH), microarray and next generation sequencing (NGS) products deliver high-quality genetic analysis, enabling accurate identification and confirmation of the causative variation underlying genetic disease. OGT was acquired by Sysmex Corporation (Sysmex), a Japanese in vitro diagnostic company in June 2017. The acquisition of OGT expands Sysmex’s life science business and reinforces its initiatives towards personalised medicine.
For more information on the Company, please visit our website at www.ogt.com.
CytoSure™, SureSeq™ and myProbes®: For Research Use Only, not for use in diagnostic procedures. Cytocell: Some products may not be available in your region.
About Sysmex Corporation
Sysmex Corporation is a world leader in clinical laboratory systemisation 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 optimise 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 8,000 employees worldwide. Sysmex Corporation is listed in the top tier of the Tokyo Stock Exchange.
For more information about Sysmex Corporation and its affiliate companies, please visit www.sysmex.co.jp/en/.