OGT announced its commitment to transition the full CytoCell fluorescence in situ hybridization (FISH) probe portfolio from CE marking under the IVD Directive (IVDD) to the IVD Regulation (IVDR). The program is designed to help clinical cytogenetics laboratories access trusted IVDR-certified FISH solutions ahead of the Class C deadline of 31st December 2028.
OGT’s IVDR program is designed to help customers maintain continuity across the CytoCell portfolio, backed by a dedicated team of clinical and technical FISH specialists. It also includes IVDR-certification of a broad range of existing custom myProbes, helping laboratories preserve access to the probes they rely on without unnecessary supplier changes or service disruption. Beyond the 2028 deadline, OGT will continue working towards IVDR certification for additional CytoCell FISH probes, including custom myProbes, to support specialist workflows over the long term.
Additionally, 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 [CE-LPA 001] and FAST FISH [CE-LPF 001] formats, including a 2-hour hybridization 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.
Visit OGT for more information
