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.
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