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OGT has launched four new IVDR-certified CytoCell FISH probes designed to detect key genetic abnormalities in hematological malignancies like leukemia, lymphoma, and multiple myeloma. The probes target translocations involving IGH and ATM genes, helping clinical labs stay compliant ahead of the EU's Class C IVDR deadline in December 2028. This expansion aims to ease labs' regulatory transition without disrupting their existing workflows.
OGT has announced the launch of four newly IVDR-certified CytoCell® fluorescence in situ hybridization (FISH) probes, expanding its diagnostic toolkit for hematological malignancies. The probes — targeting ATM deletions and IGH-related translocations — support disease characterization in conditions including non-Hodgkin lymphoma, acute lymphoblastic leukemia, chronic lymphoid leukemia, and multiple myeloma.
The move is part of OGT's broader effort to transition its CytoCell FISH portfolio from the older IVD Directive (IVDD) to the stricter IVD Regulation (IVDR) framework, ahead of the EU's Class C compliance deadline of December 31, 2028. Clinical labs can now access these familiar probes in a fully IVDR-compliant format, supported by OGT's team of on-site and digital FISH specialists.
Key Takeaways:
Why it matters: As EU regulatory requirements tighten, labs need reliable, compliant diagnostic tools that don't disrupt their workflows. OGT's expanded IVDR-certified portfolio helps clinical labs maintain high-quality cytogenetic testing for blood cancers while staying ahead of upcoming compliance deadlines.
