OGT expands range of CytoCell IVDR-certified FISH probes for haematological malignancies

Oxford, UK, November 2026. OGT, a leading global provider of genomic research and diagnostic solutions, today announced the launch of four newly available IVDR-certified CytoCell^® fluorescence in situ hybridisation (FISH) probes as part of its ongoing commitment to transition the CytoCell FISH portfolio from CE marking under the IVD Directive (IVDD) to the IVD Regulation (IVDR) ahead of the Class C deadline of 31 December 2028.

With these new probes, clinical laboratories can assess key disease-associated cytogenetic abnormalities, including for translocations involving IGH or ATM, supporting disease characterisation across a range of haematological malignancies such as non-Hodgkin lymphoma, acute lymphoblastic leukaemia, chronic lymphoid leukaemia and multiple myeloma.

"Clinical laboratories are balancing increasing regulatory requirements with the need to maintain efficient, high-quality testing workflows," said Tori Anthony-Dubernet, Director of European Sales and Support at OGT. "We’re very happy to be expanding our IVDR-certified CytoCell portfolio with these important FISH probes and to help laboratories transition to IVDR with confidence. Combined with the support of our experienced FISH specialists, customers are able to access expert guidance throughout every stage of the transition journey."

The transition of these FISH probes to IVDR helps laboratories maintain access to familiar probes from a trusted supplier while supporting compliance and their transition to IVDR-compliant workflows. In addition to regulatory confidence, CytoCell probes are designed to support efficient laboratory workflows. Reliable hybridisation performance supports reproducible results, while clear, well-defined signal patterns facilitate clear interpretation and confident reporting.

The most recent IVDR-certified probes are the CytoCell ATM Deletion FISH probe [CE-LPH 011], CytoCell IGH Plus Breakapart FISH Probe [CE-LPH 070], CytoCell IGH/FGFR3 Plus Translocation, Dual Fusion FISH Probe [CE-LPH 074] and the CytoCell IGH/MYEOV Plus Translocation, Dual Fusion FISH Probe [CE-LPH 078]. Previously available within the CytoCell IVDD portfolio, these probes have now achieved IVDR certification as part of OGT's wider regulatory programme. Alongside its expanding portfolio, OGT provides rapid on-site and digital support from clinical specialists with first-hand laboratory experience, helping laboratories validate, revalidate, implement and use IVDR-certified probes with confidence.

For more information about OGT's IVDR FISH programme, visit the CytoCell IVDR Hub.

For detailed information on the most recently certified probes, visit the CytoCell FISH Product Catalogue.

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 30 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^® IVDR-certified FISH Probe Kits: For in vitro diagnostic use. For laboratory professional use only. Not intended for use as a stand-alone diagnostic. Refer to each individual FISH probe kit’s Instructions for Use for their specific Intended Purpose, Indications, and Limitations.

About Sysmex Corporation

Sysmex Corporation, headquartered in Kobe, Japan, is a global leader in in vitro diagnostics. Since its foundation in 1968, Sysmex has focused on diagnostics as the core of its business, and today, it supports the health of people in over 190 countries and regions worldwide. Sysmex continues to innovate in diagnostics, and to collaboratively create unique values in the areas of personalized medicine and novel treatments, under its long-term vision of "Together for a better healthcare journey."* Through its unique technology, solutions, and co-creation with various partners, Sysmex delivers new value and addresses the universal desire of people to live longer and healthier lives.

For more information about Sysmex Corporation and its affiliate companies, please visit www.sysmex.co.jp/en/.

* "Healthcare journey" is a trademark of Sysmex Corporation, registered in Japan.