SHR Reference Model Version 1.0.0

Entry Element HER2ReceptorStatus


HER2 receptor status. HER2 is a member of the human epidermal growth factor receptor family of proteins and is encoded by the ERBB2 oncogene. HER2 is overexpressed in 20-30% of breast tumors, and is associated with an aggressive clinical course and poor prognosis. HER2 status (positive=present or overexpressed; negative=absent) is a factor in determining prognosis and treatment options.

We are seeking feedback if it is better to put the positive/negative status in Value or Interpretation. The current approach is that positive/negative designation is a value, even though that value is (in fact) an interpretation of evidence from HER2 by IHC and/or HER2 by ISH tests, not a direct observation.