OGT has announced that it has begun transitioning its CytoCell fluorescence in situ hybridisation (FISH) probe portfolio from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR), starting with two newly certified prenatal FISH probe kits.
The UK-based genomics company said the programme is intended to help clinical cytogenetics laboratories maintain compliant and validated workflows ahead of the 31st December 2028 IVDR deadline for Class C in vitro diagnostic devices.
The first products to complete the transition are CytoCell Prenatal X, Y, 13, 18 and 21 FISH probe kits, designed for routine and rapid aneuploidy testing in prenatal diagnostic laboratories.
The kits are available in standard and FAST FISH formats.
The FAST FISH option provides a two-hour hybridisation workflow for time-critical testing, enabling laboratories to generate results more rapidly while retaining an established FISH-based approach.
OGT said the remainder of its CytoCell catalogue will transition in tranches at regular intervals through to the 2028 deadline.
The programme will also cover a broad range of existing custom myProbes products, which are developed for laboratories requiring specialist FISH workflows.
The company said transitioning existing custom probes is intended to help laboratories maintain access to established products without unnecessary supplier changes or disruption to diagnostic workflows.
OGT was the first FISH probe manufacturer to obtain IVDR certification for its products in 2023.
The firm added that the broader transition programme builds on this experience and will be supported by clinical and technical FISH specialists.
For clinical laboratories, the transition from IVDD to IVDR has required manufacturers to reassess and certify diagnostic products against more stringent regulatory requirements, while laboratories must ensure their workflows remain compliant as existing CE-marked products transition.
Faidra Partheniou, Vice-President of Regulatory & Medical Affairs at OGT, said the full portfolio transition was intended to give laboratories greater certainty as they plan for the regulatory changes.
Beyond the 2028 deadline, OGT said it will continue pursuing IVDR certification for additional CytoCell FISH probes, including custom myProbes, to support specialist clinical and diagnostic applications.
