OGT has announced the launch of four new IVDR-certified CytoCell fluorescence in situ hybridisation (FISH) probes.
The launch is part of the firm's 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.
The IVDD was a European Union legal framework adopted in 1998 to regulate in vitro diagnostic medical devices, such as blood tests, pregnancy kits and clinical chemistry analysers.
The IVDR has since replaced it and introduced a four-class risk system (Classes A, B, C and D), stricter clinical evidence rules and mandatory involvement from Notified Bodies for a broader range of products.
These risk classifications have different transition periods, with Class C requiring full certification by December 31, 2028.
The CytoCell FISH probes are designed to detect clinically relevant variants, such as translocations involving IGH or ATM, associated with haematological malignancies, including chronic lymphocytic 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 will help laboratories maintain access to familiar probes from a trusted supplier while supporting compliance and their transition to IVDR-compliant workflows.
The most recent IVDR-certified probes are the CytoCell ATM Deletion FISH probe [CE-LPH 011], CytoCell IGHPlus 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, the company said that these probes have now achieved IVDR certification as part of its wider regulatory programme.
