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

Oxford, UK – 30 January 2019. OGT, The Molecular Genetics Company, has been granted de novo classification by the US Food and Drug Administration (FDA) for eight CytoCell^® Hematology fluorescence in situ hybridization (FISH) probes for acute myeloid leukemia (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 hematological 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 FISH probes is:

• AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion
• CBFβ (CBFB)/MYH11 Translocation, Dual Fusion
• Del(5q) Deletion
• Del(7q) Deletion
• Del(20q) Deletion
• EVI1 (MECOM) Breakapart
• MLL (KMT2A) Breakapart
• P53 (TP53) Deletion

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 minimizes 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 OGT. “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.”

Intended Use

The CytoCell 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 Tumors of Hematopoietic 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.

About OGT

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.

For more information on the Company, please visit our website at 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 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 9,000 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/.