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Best Practice No 176: Updated recommendations for HER2 testing in the UK
I O Ellis1, J Bartlett, M Dowsett
1Department of Histopathology, Nottingham City Hospital, Hucknall Road, Nottingham NG5 1PB, UK. ian.ellis@nottingham.ac.uk
Journal of Clinical Pathology
|March 3, 2004
Summary
Updated guidance for HER2 laboratory testing in advanced breast cancer is provided. A two-phase testing algorithm and minimum caseloads ensure accurate HER2 assessment for targeted therapy.
Area of Science:
- Oncology
- Pathology
- Genetics
Background:
- The UK recommends HER2-targeted treatment for advanced breast cancer, necessitating updated laboratory testing guidelines.
- Previous guidance requires revision to reflect current clinical practice and diagnostic advancements.
Framework:
- A standardized two-phase testing algorithm is proposed, starting with immunocytochemistry (ICC).
- Borderline cases will undergo second-line fluorescence in situ hybridization (FISH) assessment.
- Emphasis is placed on methodology standardization and quality assurance for reliable results.
Implementation:
- Laboratories should adopt the recommended ICC and FISH testing algorithm.
- Strategies for maintaining high-quality performance in HER2 testing are detailed.
- An annual caseload of at least 250 cases is recommended for testing laboratories to maintain expertise.
Implications:
- This guidance aims to ensure accurate HER2 status determination for effective patient treatment.
- Standardized testing protocols will improve the reliability and reproducibility of HER2 diagnostics.
- Adherence to recommendations supports optimal patient management in advanced breast cancer care.