Standardized versus research-based PAM50 intrinsic subtyping of breast cancer

Excerpt

To date, there is only one standardized assay for identification of the so-called intrinsic molecular subtypes of breast cancer (i.e., Luminal A, Luminal B, HER2-enriched, and Basal-like) described by Perou et al. [1]. This assay uses the nCounter technology, has been CE Marked, and is commercially available worldwide [2]. Over the years, however, several research-based methods for subtype identification have been reported [3‐5]. However, none of them is standardized and, in most cases, proper controls or data to suggest that the method is accurate and precise compared to the standardized and clinically validated nCounter-based PAM50 assay are missing [6, 7]. This is worrisome, since important conclusions regarding the prognostic or predictive value of the PAM50 subtypes are being drawn from “homebrew” research-based PAM50 versions often run on different technologies. …