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

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 hybridization (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 characterization across a range of hematological malignancies such as non-Hodgkin lymphoma, acute lymphoblastic leukemia, chronic lymphoid leukemia and multiple myeloma.

Tori Anthony-Dubernet, Director of European Sales and Support, OGTClinical laboratories are balancing increasing regulatory requirements with the need to maintain efficient, high-quality testing workflows, 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 hybridization performance supports reproducible results, while clear, well-defined signal patterns facilitate clear interpretation and confident reporting.

Source:

OGT