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OGT Hematological Cancer FISH Probes Get IVDR Certification
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Fusion42 · 2 November 2026 · Fusion42 review
OGT's four CytoCell FISH probes for hematological malignancies have received certification under the EU's In Vitro Diagnostics Regulation (IVDR). This approval allows these diagnostic tools to be marketed across the EU under the new regulatory framework.
This Wire brief sits within Fusion42's coverage of Diagnostics, and 2 sources have reported it.
◆ ◆ The Wire takeaway
You now face a higher regulatory bar to market diagnostic tools in the EU. Getting IVDR certification early lets you enter or stay competitive in the European diagnostics market.
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2 sources · 2 Nov 2026
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