OGT has launched two newly certified prenatal genetic tests as part of a wider programme to move its diagnostic products to updated European regulatory standards.
The new CytoCell tests are used by clinical laboratories to detect specific chromosome abnormalities during pregnancy, including those associated with Down, Edwards and Patau syndromes.
A rapid version uses a two-hour hybridisation process, helping laboratories deliver results more quickly when time is critical.
The launch forms part of OGT’s wider programme to transition its CytoCell FISH probe portfolio to the EU’s In Vitro Diagnostic Regulation (IVDR). FISH probes are specialist genetic testing tools that use fluorescent markers to detect specific changes in chromosomes.
The updated regulation sets higher standards for the quality and safety of diagnostic medical devices. OGT is working to transition its CytoCell range to the new requirements, helping laboratories maintain access to established tests as they move to the newer regulatory framework.
OGT was the first manufacturer of FISH probes to achieve IVDR certification for its products in 2023 and has more than 30 years’ experience developing genomic solutions for research and clinical diagnostics.