1. HER2 Human Epidermal growth factor Receptor 2 Excess HER2 gene leads to over expression of HER2 protein 20-30% Of breast cancers over express HER2

2. Her2 and breast cancer  Prognostic marker: Poor clinical outcomes  Predictive marker: Response to Transtuzumab [Herceptin] Tamoxifen resistance Anthracyclines

3. Which patients?  All patients with metastases.  All newly diagnosed patients.

4. How? Immunocytochemistry: antibody to HER2 protein [gene product] 0/1+Negative 2+Equivocal 3+Positive

5. In Situ Hybridisation [ISH] F.I.S.H. [Fluorescent ISH] quantifies the gene amplification

6. Herceptin in early breast cancer  ASCO 2005 HERA and NSABP B-31 October 2005 DoH SEHD

7. WoSCAN  Testing: All newly diagnosed patients All metastatic cases  I.H.C Ayrshire and Arran [2002] Glasgow [2004] {Lanarkshire, Argyll and Clyde, Forth Valley.} Dumfries and Galloway  FISH Glasgow

8. SCAN  Testing All metastatic cases All “ high risk” new diagnoses  IHC & FISH Edinburgh {Lothian, Fife and the Borders}

9. NoSCAN  Grampian Testing: All newly diagnosed cases All metastatic cases  Aberdeen IHC Pathology FISH Cytogenetics

10.  Inverness Testing: Metastatic cases only  IHC & FISH Pathlore

11.  Tayside Testing: All new cases All metastatic cases  Dundee IHCPathology FISHCytogenetics

12. Strengths  Substantial numbers of new patients already tested.  NEQAS participation  Innovative approach  Utilising regional MCNs

13. Challenges  Not all new patients being tested  Backlog  Funding  Quality assurance  Turnaround times  Numbers  IHC which antibody?

14. HER2 Service  All pertinent patients  Quality Assurance Standards  Results available in clinically relevant timescales.

15. Molecular Diagnostics  Comprehensive  Infrastructure  Versatile