Transition programme begins with two IVDR-certified CytoCell prenatal FISH probe kits designed to support rapid, standardised prenatal workflows.
OGT, a leading global provider of genomic research and diagnostic solutions, today 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 31st December 2028.
Supporting laboratories through IVDR transition
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.
OGT has long offered a comprehensive CE marked under IVDD portfolio and was the first manufacturer of FISH probes to obtain the new IVDR certification on its products in 2023. This full transition programme reflects OGT’s ongoing commitment to providing products that meet the needs of clinical laboratories and their patients while maintaining high standards of regulatory compliance. The programme 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.
Newly IVDR-certified prenatal probe kits for routine and rapid workflows
To mark their 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 [CE-LPA 001] and FAST FISH [CE-LPF 001] formats, including a 2-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.
Commitment to continuity and support
“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 & 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.”
OGT and the CytoCell brand are trusted by laboratories worldwide for quality FISH probes and long-term support. With over 30 years of experience at the forefront of genetic endeavour, OGT continues to work closely with customers to understand their challenges and provide solutions that support clinical and diagnostic genomic workflows.
For more information about OGT’s CytoCell FISH probe portfolio and IVDR programme, please visit: www.ogt.com
For further information, please contact:
Oxford Gene Technology, Unit 5, Oxford Technology Park, 4A Technology Drive, Kidlington, Oxfordshire, OX5 1GN, United Kingdom
T: +441865 856800
E: contact@ogt.com ; W: www.ogt.com ; Twitter: @OxfordGeneTech
About OGT
OGT, a Sysmex Group company, is a leading global provider of clinical and diagnostic genomic solutions that are created for scientists by scientists – including CytoCell®, CytoSure® and SureSeq™ ranges of FISH, microarray and NGS products. The company is dedicated to creating products that enable researchers and clinical decision makers to reach the right care decisions for each patient, every time. OGT strives to unlock the future of genetic clinical care with a commitment to working in partnership with its customers – not only by sharing its expertise of 30 years at the forefront of genetic endeavour, but also by working closely with scientists to understand their unique challenges, and to customise its approach to meet their exact needs. Dedicated to improving clinical care, OGT believes that through partnership—together—we’ll achieve more.
For more information on the Company, please visit our website at www.ogt.com
