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

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.

Fully Integrated Single Instrument Imaging-based Digital PCR Platform

Digital PCR (dPCR) has gained popularity in recent years for cancer research such as rare
mutation detection, minimal residual disease, treatment selection, and recurrence monitoring. However, currently available technologies suffer from several limitations such as tedious workflow, long time-to-result, poor multiplexity, and inconsistent reagent digitization, which has severely hindered its broad adoption. We have designed and manufactured a dPCR platform that is capable of consistent sample digitization, thermal cycling and simultaneous interrogation of 20,000 partitions with walk-away workflow.

BCR/ABL Gene Expression Assay on the Combinati Absolute Q

95% of Chronic Myeloid Leukemia (CML) cases are characterized by the presence of a BCR-ABL1 fusion gene. Regular monitoring involving precise quantification of BCR-ABL1 transcripts is integral to successful tyrosine kinase inhibitor (TKI) treatment. Read more about how samples with precise ratios of BCR-ABL1/ABL1 were created and confirmed on the Combinati dPCR platform.