OGT, a global provider of genomic research and diagnostic solutions, has announced its commitment to transition the full CytoCell fluorescence in situ hybridisation (FISH) probe portfolio from CE marking under the IVD Directive (IVDD) to the IVD Regulation (IVDR).
The programme is designed to help clinical cytogenetics laboratories access trusted IVDR-certified FISH solutions ahead of the Class C deadline of 31 December 2028.
To mark its IVDR commitment, OGT has launched two IVDR-certified CytoCell prenatal FISH probe kits, with the remainder of the CytoCell catalogue probes and a range of existing custom myProbes to transition in tranches at regular intervals up to the December 2028 deadline.
The newly IVDR-certified CytoCell Prenatal X, Y, 13, 18 and 21 probe kits are designed for clinical cytogenetics and prenatal diagnostic laboratories requiring IVDR-certified FISH probes for routine and rapid aneuploidy testing. Available in both ‘standard’ and ‘fast’ FISH formats, including a two-hour hybridisation workflow for time-critical testing. Together, these formats help laboratories generate results faster from one trusted supplier and support confident clinical decision-making during prenatal care.
“By committing to the full IVDD portfolio transition, marked by the launch of the latest IVDR CytoCell Prenatal FISH Probe kits, we are helping laboratories plan with confidence through the IVDR transition and maintain access to the FISH probes that support their established workflows.” said Faidra Partheniou, Vice-President of Regulatory and Medical Affairs at OGT “Our IVDR FISH probes are designed and manufactured with the same level of excellence our customers expect, and IVDR certification formally recognises their established quality, safety and performance, giving laboratories confidence in both their results and their regulatory readiness. At OGT our priority is to ensure customers have robust, reliable products and a FISH partner they can depend on.”
Clinical cytogenetics laboratories in the EU and other IVDR-aligned markets are under increasing pressure to maintain compliant, validated workflows while managing the practical impact of their portfolio transition. OGT’s IVDR programme is designed to help customers maintain continuity across the CytoCell portfolio, backed by a dedicated team of clinical and technical FISH specialists.