OGT has launched four newly available IVDR-certified CytoCell fluorescence in situ hybridization (FISH) probes as part of its transition of the CytoCell FISH portfolio from CE marking under the IVD Directive (IVDD) to the IVD Regulation (IVDR) ahead of the Class C deadline of December 31, 2028.
With these new probes, clinical laboratories can assess key disease-associated cytogenetic abnormalities, including for translocations involving IGH or ATM, supporting disease characterization across a range of hematological malignancies such as non-Hodgkin lymphoma, acute lymphoblastic leukemia, chronic lymphoid leukemia, and multiple myeloma.
The most recent IVDR-certified probes are:
CytoCell ATM Deletion FISH probe [CE-LPH 011]
CytoCell IGH Plus Breakapart FISH Probe [CE-LPH 070]
CytoCell IGH/FGFR3 Plus Translocation, Dual Fusion FISH Probe [CE-LPH 074]
CytoCell IGH/MYEOV Plus Translocation, Dual Fusion FISH Probe [CE-LPH 078]
