HER2 Gene Amplification in Breast Cancer
HER2 Gene Amplification in Breast Cancer
During the past 24 months, we have performed an ongoing audit of cases on which ISH was performed at one of the busiest UK HER2 testing centers and reference sites. The Birmingham Heartlands Hospital Molecular Pathology Laboratory, Birmingham, England, acts as a local testing center, a referral center, and a UK National External Quality Assessment Service (NEQAS) reference center for HER2 ISH and immunohistochemical testing. With an annual HER2 immunohistochemical caseload in excess of 2,200 cases and an annual ISH caseload of more than 800 cases, this represents a significant pool from which to draw unusual cases. During the 24-month period in question, 1,787 cases were referred for ISH testing, and these form the basis of the current audit. By using HER2 FISH cases from this center, we have identified the frequency and specific examples of challenging or rogue cases. The images and results from these cases were then circulated to selected UK NEQAS reference laboratories, and a consensus diagnostic opinion was generated by consultation with molecular diagnosticians, cytogeneticists, and pathologists. We also draw recommendations for future research to further test and validate these diagnostic approaches.
Materials and Methods
During the past 24 months, we have performed an ongoing audit of cases on which ISH was performed at one of the busiest UK HER2 testing centers and reference sites. The Birmingham Heartlands Hospital Molecular Pathology Laboratory, Birmingham, England, acts as a local testing center, a referral center, and a UK National External Quality Assessment Service (NEQAS) reference center for HER2 ISH and immunohistochemical testing. With an annual HER2 immunohistochemical caseload in excess of 2,200 cases and an annual ISH caseload of more than 800 cases, this represents a significant pool from which to draw unusual cases. During the 24-month period in question, 1,787 cases were referred for ISH testing, and these form the basis of the current audit. By using HER2 FISH cases from this center, we have identified the frequency and specific examples of challenging or rogue cases. The images and results from these cases were then circulated to selected UK NEQAS reference laboratories, and a consensus diagnostic opinion was generated by consultation with molecular diagnosticians, cytogeneticists, and pathologists. We also draw recommendations for future research to further test and validate these diagnostic approaches.
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