Comparison of HER2 testing among laboratories: Our experience with review cases retested at Moffitt Cancer Center in a two-year period.

Determination of human epidermal receptor protein-2 (HER2) is a crucial step in the treatment of patients diagnosed with invasive breast carcinoma. HER2 status is an independent clinical prognostic factor and a predictive factor of tumor response to chemotherapeutic agents such as trastuzumab. Accurate testing is necessary to offer adequate therapy to patients. To evaluate the variation in HER2 testing results, we analyzed our data from review cases in which HER2 testing was repeated at our institution from January 2013 to December 2014. For the study, the reason for repeating the test, the testing methodology used, and the tests results were collected. Concordance between outside and in-house HER2 results was compared. Discrepancies were classified as major and minor. A total of 173 cases were retested during this period. One-hundred and twenty-eight cases met the inclusion criteria. Sixteen cases were originally tested at large reference laboratories and two in international laboratories. In the 110 remaining cases, the test was performed at small community laboratories or the testing facility was not available. Forty-one (32%) discrepancies were identified. Of these, 15 (12% of 128 total) were major and 26 (20% of 128 total) were considered minor discrepancies. Our study confirms that significant discrepancies in HER2 results persist even after stricter and well-developed testing guidelines have been embraced.