The results of a DXRX collaboration which started in 2020 have recently been presented at the San Antonio Breast Cancer Symposium (SABSC2022). The aim of the study was to provide comprehensive concordance data of HER2-low scoring in breast cancer and understand the impact virtual pathologist training could have on improving identification of HER2 low results.
This included :
- assessment of baseline proficiency for 77 pathologists of HER2-low scoring in breast cancer for the 4B5 or Dako HercepTest assays
- assessment of the effect of training on pathologist proficiency and to provide comprehensive concordance data of HER2-low scoring in breast cancer for these two assays, separately, after specific reader training
The identification of patients with HER2-low is of importance because, as a result of the efficacy demonstrated in DESTINY-Breast04, the US Food and Drug Administration (FDA) has approved trastuzumab deruxtecan T-DXd for the treatment of HER2-low mBC and the Ventana PATHWAY 4B5 companion diagnostic (4B5) to determine patients having HER2-low mBC1,6,7
Diaceutics would like to extend our thanks to everyone who engaged in this successful collaboration.
1. Modi S et al. N Engl J Med. 2022;387:9-20. 6. Enhertu. Package insert. Daiichi Sankyo, Inc.; 2022.
7. Food and Drug Administration. List of Cleared or Approved Companion Diagnostic Devices.
Accessed October 11, 2022. https://www.fda.gov/medical-devices/in-vitro-diagnostics/listcleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools