Fluorescently Labelled FISH Probes for Cancer Diagnostics at St James's Hospital

Invitation to tender for the Provision of fluorescently labelled probes for the Fluorescent in situ Hybrisisation (FISH) Service in the Histopathology Dept at St James’s Hospital. The FISH service at SJH has provided a hospital and national service since 2010, helping on cancer classification and to guide patient treatment.

The laboratory now requires the provision of the following fluorescently labelled ready to use probes: • MYC (8q24) Break Apart FISH probe, to detect chromosomal rearrangements involving the MYC gene on Chromosome 8q24. • t(8;14) MYC/IGH dual-fusion FISH probe, to detect reciprocal translocation involving the IGH and MYC genes.

• BCL2 (18q21) Break Apart FISH probe, to detect chromosomal rearrangements involving the BCL2 gene on Chromosome 18q21. • t(14;18) IGH/BCL2 DF dual-fusion FISH probe, to detect reciprocal translocations involving the IGH and BCL2 genes. • BCL6 (3q27) Break Apart FISH probe, to detect chromosomal rearrangements involving the BCL6 gene on Chromosome 3q27.

• MALT1 (18q21) Break Apart FISH probe, to detect chromosomal rearrangements involving the MALT1 gene on Chromosome 18q21. • t(11;14) CCDN1/IGH dual-fusion FISH probe, to detect reciprocal translocations involving the IGH and CCDN1 genes. • IgK-cMYC dual-fusion FISH probe, to detect reciprocal translocation involving the IGK and MYC genes.

• IgL-cMYC dual-fusion FISH probe, to detect reciprocal translocation involving the IGL and MYC genes. • DUSP22-IRF4 Break Apart FISH probe, to detect chromosomal rearrangements involving the DUSP22 or IRF4 gene. • TP63 Break Apart FISH probe, to detect chromosomal rearrangements involving the TP63 gene. • 11q gain-loss FISH probe, to detect 11q Aberration.

• ALK (2p23) Break Apart FISH probe, to detect chromosomal rearrangements involving the ALK gene on Chromosome 2p23. • ROS1 (6q22) Break Apart FISH probe, to detect chromosomal rearrangements involving the ROS1 gene on Chromosome 6q22. • MDM2/CEN12 Amplification FISH probe, to detect MDM2 gene amplification. • EWSR1 Break Apart FISH probe, to detect chromosomal rearrangements involving the EWSR1 gene.

• MAML2 Break Apart FISH probe, to detect chromosomal rearrangements involving the MAML2 gene. • MYB Break Apart FISH probe, to detect chromosomal rearrangements involving the MYB gene. • FGFR2 Break Apart FISH probe, to detect chromosomal rearrangements involving the FGFR2 gene.

• DAPI Counterstain The provider must be able to provide IVDR-certified probes in compliance with the Regulation for in vitro diagnostic medical devices (IVDR) for the diagnostic FISH service. Currently, the FISH technique is performed as a semi-automated assay on formalin-fixed, paraffin-embedded material.

Therefore, the provider must be able to provide fluorescently labelled probes intended to be used on formalin-fixed, paraffin-embedded specimens in a ready to use format. Vendors must supply the different probe types used by the FISH service in SJH, ensuring reliable and reproducible results and long-term serviceability and user training.

The provider must be able to provide IVDR-certified probes in compliance with the Regulation for in vitro diagnostic medical devices (IVDR) for the diagnostic FISH service. Vendors rs must supply the different probe types used by the FISH service in SJH, ensuring reliable and reproducible results and long-term serviceability and user training.