Discriminatory 11-Plex Assay Designed to Monitor Estrogen Receptor Mutations Using a Novel, Melt-Analysis Capable Digital PCR Platform​

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In a large fraction of ER+/HER2- metastatic breast cancer (MBC), treatment with aromatase inhibitors fails due to emerging resistance. A key mechanism of this resistance is associated with a set of missense mutations in the gene encoding for the estrogen receptor (ESR1). We have developed a multiplex, quantitative, Research Use Only assay for the detection and identification of 11 ESR1 single nucleotide polymorphisms (SNPs) and the ESR1 gene in a single reaction, using patented, melt-based chemistry and an innovative digital PCR (dPCR) system.