There continues to be a challenge for determining use of Trastuzumab therapy for breast and gastric patients with borderline HER2 results. The assays that are used to obtain the required data to populate these equivocal algorithms have not been standardized. A new study has been published that quantitatively evaluates the current recommendations for assessing HER2 amplifications. Using a statistical simulation approach, the study accomplished two main objectives. The first is the variability of the HER2 status diagnoses, and the second focuses on ISH methodologies and how different approaches for computing ratios could lead to different amplification results for borderline patients. The study is able to show the limitations of the current HER2 guidelines, and the need for accurate data analysis standardization.
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