Wire · operational-macro
Does NGS replace FISH for hematological malignancy calls?
◆ Sectors
◆ Geography
◆ Source
◆ Verified
Fusion42 · 2 November 2026 · Fusion42 review
IVDR-certified CytoCell FISH probes for IGH translocation and ATM deletion remain essential in EU hematology labs for diagnosing chronic lymphocytic leukemia and multiple myeloma, offering faster results and structural detection that NGS panels cannot fully replace. Newly certified probes help labs comply with EU regulations while covering critical diagnostic gaps in hematological malignancies.
This Wire brief sits within Fusion42's coverage of Health, and 2 sources have reported it.
◆ ◆ The Wire takeaway
EU hematology labs face a regulatory push to recertify critical FISH probes that NGS cannot replace due to speed and detection limits. You need to prioritise compliance with IVDR deadlines while maintaining FISH testing capabilities for hematological malignancies.
◆ Coverage
2 sources · 2 Nov 2026
◆ Related on Wire
◆ Topics