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The Atellica™ IM Her‑2/neu (H2n) assay is for in vitro diagnostic use in the quantitative determination of the HER‑2/neu protein in human serum using the Atellica™ IM Analyzer
HER‑2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER‑2/neu level is > 15 ng/mL
The clinical utility of the measurement of HER‑2/neu in serum as a prognostic indicator for early recurrence and in the management of patients on immunotherapy has not been fully established