The predictive status of IHC biomarkers were leveraged by using HR and HER2 status as way to group patients with the same expected treatment response before choosing the best set of genes for each subtype signature. Conversely to other assays for breast cancer molecular subtyping, BluePrint was developed to bridge clinical pathology and research molecular subtyping, resulting in a molecular diagnostic assay with predictive value. The BluePrint 80-gene breast cancer molecular subtyping test is unique in that it was developed using the IHC-based clinical subtype as a guide. While there is still not a gold standard for molecular subtyping, these three subgroups are the most universally recognized across different subtyping methods. These clinical subtypes have closely correlated molecular subtype equivalents where HR-positive patients are mostly Luminal-type, triple-negative are Basal-type, and HER2-positive are HER2-type. triple negative) and HER2-positive clinical subtypes. The less abundant subgroups include patients with HR-negative/HER2-negative (i.e. The majority of BC patients are classified as HR-positive/HER2-negative, steadily comprising about 70% of all BC cases, , ]. Estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) are well established as the gold standards in IHC testing and used to classify patients into what are now generally accepted clinical subtypes. Multiple methods have been utilized to categorize the heterogeneity into distinct subgroups, be it with immunohistochemistry (IHC) for hormone receptor (HR) protein status or more recently with RNA-based assays for molecular subtypes, , ]. Breast cancer (BC) is a heterogenous disease in nearly all aspects of disease progression from genetic risk and environmental accelerators, to growth and metastatic potential, and finally to treatment response.
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