FDA grants de novo designation for OGT’s AML/MDS FISH probes

Wednesday 30 January 2019
Product types:
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Oxford, UK – 29th January 2019. Oxford Gene Technology (OGT), The Molecular Genetics Company, has been granted de novo classification by the US Food and Drug Administration (FDA) for eight Cytocell Aquarius® Haematology fluorescence in situ hybridisation (FISH) probes for acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS).

The probes form the largest FDA-cleared in vitro diagnostic (IVD)* FISH probe range for AML and MDS on the market and will address a substantial proportion of diagnostic laboratory haematological FISH testing.

The cleared probes will significantly reduce the level of validation required in laboratories and provide accurate, easy-to-interpret detection of chromosomal rearrangements reported in AML and MDS.

The full list of FDA-cleared Cytocell Aquarius FISH probes is:

The probes are supplied pre-mixed and ready-to-use as part of a complete kit including DAPI, detailed protocols and signal pattern analysis guidelines which streamlines processing and minimises errors – delivering increased convenience and reliable results. Bright, tight, and high-intensity signals with excellent contrast all simplify analyses for confident results, while decreasing retest rates. All Cytocell FISH probe users also benefit from OGT’s renowned expert technical support, enabling laboratories to remain focused on delivering high quality, rapid results to their patients.

“We’re delighted to bring our comprehensive range of FDA-cleared AML and MDS FISH probes to market”, commented Steve Chatters, Director of Medical Affairs at Oxford Gene Technology. “The rigorous FDA de novo pathway requires submission of extensive clinical and performance data from multiple sites, along with robust evidence of the safety and effectiveness of the probes. What this means for customers, particularly in the US, is a significant reduction in the validation burden and immediate access to a range of high-quality IVD probes covering a comprehensive set of rearrangements. Our customers will be able to easily and accurately detect pertinent chromosomal rearrangements in fixed bone marrow specimens without needing to complete lengthy validations for every probe prior to use.”

Dr John Anson, CEO at OGT added, “Gaining FDA clearance for this range of probes is a real milestone for OGT and our customers, demonstrating our continued commitment to developing and providing molecular diagnostic solutions as part of Sysmex. We see FISH technology very much as a long-term diagnostic solution and we are committed to continuing to expand the Cytocell portfolio with new diagnostic products. This is a significant step towards achieving that goal, immediately benefiting our customers by providing access to the largest range of FDA-cleared FISH probes for AML and MDS currently on the market.”

For more information please visit www.cytocell-us.com/fda-cleared

 

Intended Use

The Cytocell Aquarius AML/MDS range of FISH probe test kits are fluorescence in situ hybridization (FISH) tests used to detect common chromosomal rearrangements in fixed bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The tests are indicated for the characterization of patient specimens consistent with World Health Organization guidelines for Classification of Tumours of Haematopoietic and Lymphoid Tissues (Revised Edition 4) and in conjunction with other clinicopathological criteria. The assay results are to be interpreted by a qualified pathologist or cytogeneticist. The tests are not intended for use as a stand-alone diagnostic, disease screening, or as a companion diagnostic.

Refer to individual test kit pack insert for the specific intended use and limitations.

For In Vitro Diagnostic Use. RX Only

 

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 856807; F: +44 (0) 1865 848684

E: contact@ogt.com ; W: www.ogt.com ; Twitter: @OxfordGeneTech

 

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/.