OGT has 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).
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, ahead of the Class C deadline of 31 December 2028, 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.