We perform over 2000 HER2 Immunohistochemistry and 800 FISH tests per year, on breast cancer cases, using FDA approved and validated assays ( Pathway 4B5 antibody from Roche/Ventana and PathVysion dual colour FISH probe from Abbott Molecular (both CE marked)
All testing is performed in accordance with National Guidelines.
Bartlett JMS, Starczynski J et al. HER2 testing in the UK: recommendations for breast and gastric in-situ hybridisation methods. J Clin Pathol 2011; 64: 649-653)
Woolff AC, Hammond EH et al. American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Human Epidermal Growth Factor 2 Testing in Breast Cancer. J Clin Oncol 2007; 25 (1): 118-145
Walker RA, Bartlett JMS et al. HER2 testing in the UK: further update to recommendations. J Clin Pathol 2008; 61: 818-824
Ellis IO, Dowsett M et al. Recommendations for HER2 testing in the UK. J Clin Pathol 2000; 53: 890-2
Ellis IO, Bartlett J et al. Updated recommendations for HER2 testing in the UK. J Clin Pathol 2004; 57: 233-7)
We are a national reference centre laboratory for HER2 testing
We participate in national UKNEQAS scheme for HER2 testing
We are actively involved in monitoring and auditing all aspects of the HER2 service to best meet the need of our users.
For Clinical advice and interpretation please contact one of the above pathologists.
From September 2012: For clinical advice and interpretation please contact Dr J Starczynski on the above telephone number
All samples submitted for HER2 testing must be accompanied by a request form detailing the patient name, DOB, NHS number and laboratory number of the requesting laboratory. A copy of the histology report should also be included.
A representative paraffin wax block should be submitted for testing, which should contain sufficient tumour material for the HER2 status to be determined.
Alternatively, we do accept tissue sections on charged, Menzel Glazer slides.
If slides are to be sent please provide 5 sequential sections, cut at 4μm, on to charged slides, maintaining placement and orientation on the slide. The slides must be labelled with the laboratory number, including any suffix/part number, patient name and the date that the sections were cut. Sections must be dried overnight at 37 degrees C. Do not heat on.
If slides are being sent for HER2 FISH analysis only, please ensure that the original HER2 immunohistochemistry slide is also included.
Please ensure that the spare sections being sent are representative of the IHC slide that is sent.
Referred blocks are returned to the referring laboratory by recorded delivery once the case has been reported.
Limitations of test
Samples should preferably be fixed in 10% neutral buffered formalin for 6 – 48 hrs. Suboptimal fixation, either insufficient or extended, can cause problems when determining HER2 status.
The use of marker dyes, such as eosin and carbol fuchsin, on breast core biopsies should be avoided as this causes auto-fluorescence on FISH samples making them difficult to interpret.
Heavy use of marker dyes on resection specimens may also cause problems in interpretation on FISH samples.
Turnaround Times for HER2 testing
The turnaround time for HER2 immunohistochemistry is 14 days from receipt of the sample.
For information regarding quotes for testing please contact:
Protection of Personal Information – Laboratory Medicine comply with the Trust Data Protection Policy and have procedures in place to allow the Directorate and it’s employees to comply with the Data Protection Act 1998 and associated best practice and guidance.
The Trust Laboratories at Heartlands Hospital, Good Hope Hospital and Solihull Hospital were awarded UKAS (United Kingdom Accreditation Service) accreditation to the internationally recognised ISO 15189 standard in May 2015. For a list of accredited tests and other information please visit the test database http://www.heftpathology.com/frontpage/test-database.html. Tests not appearing on this scope are either under consideration or in the process of accreditation and so currently remain outside of our scope of accreditation. However, these tests have been validated to the same high standard as accredited tests and are performed by the same trained and competent staff.
For further information contact Louise Fallon, Quality Manager, 0121 424 1235