OGT expands range of CytoCell IVDR-certified FISH probes for hematological malignancies (opens in a new tab)

news-medical.net · 2026-11-03

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OGT expands range of CytoCell IVDR-certified FISH probes for hematological malignancies

news-medical.net · 2026-11-03

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Multiple potential source studies identified.

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Claim 1 of 4Not checkedOGT announced the launch of four newly available IVDR-certified CytoCell fluorescence in situ hybridization (FISH) probes.View evidenceHide evidence

As statedfour newly available probes

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Claim 2 of 4Not checkedThe probes are part of OGT's ongoing 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 31 December 2028.View evidenceHide evidence

As statedahead of the Class C deadline of 31 December 2028

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Claim 3 of 4Not checkedClinical laboratories can use the probes to assess disease-associated cytogenetic abnormalities, including translocations involving IGH or ATM, across hematological malignancies such as non-Hodgkin lymphoma, acute lymphoblastic leukemia, chronic lymphoid leukemia and multiple myeloma.View evidenceHide evidence

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Claim 4 of 4Not checkedThe company says the IVDR transition helps laboratories maintain access to familiar probes, support compliance, and use efficient workflows with reliable hybridization and clear signal patterns for interpretation and reporting.View evidenceHide evidence

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