Development of a multiplex dPCR assay for ERBB2 amplification in breast cancer

Background: ERBB2 amplification on chromosome 17 serves as a marker for monoclonal antibodies targeting HER2 in cancers, most notably in breast cancer. Although immunohistochemistry (IHC) and in situ hybridization (FISH/SISH/CISH) remain the gold standard for clinical diagnosis of ERBB2 amplification, their semiquantitative and subjective nature are limitations that warrant the exploration of alternative quantitative, reliable, rapid, and cost-effective complementary approaches such as digital PCR (dPCR). Here we describe initial results with a dPCR-based SAGAplex™ assay for ERBB2 amplification.