Bio-Rad launches first ultrasensitive multiplexed digital PCR assay for breast cancer mutation detection in clinical research

Bio-Rad Laboratories, Inc., a global leader in life science research and clinical diagnostic products, today announced the launch of its first ultrasensitive multiplexed digital PCR assay, the ddPLEX ESR1 Mutation Detection Kit. The assay expands the company’s Droplet Digital PCR (ddPCR^™) offering for the oncology market, where highly sensitive and multiplexed mutation detection assays aid translational research, therapy selection, and disease monitoring. 

The ddPLEX ESR1 Mutation Detection Kit enables simultaneous detection, discrimination, and absolute quantification of seven known relevant ESR1 mutations, in a single well, with an analytical sensitivity down to 0.01% variant allele fraction (VAF). The kit includes controls and enables same-day results from either circulating tumor DNA (ctDNA) from plasma or DNA from formalin-fixed paraffin-embedded (FFPE) tissue samples. This research use assay is developed for Bio-Rad’s QX600 Droplet Digital PCR System, which brings advanced multiplexing and unmatched sensitivity to a simple workflow with powerful data analysis. The assay is the first to license NuProbe’s allele enrichment technology, in a collaboration the two companies announced in 2022. 

“With the ddPLEX ESR1 Mutation Detection Kit, our customers can achieve new levels of sensitivity and multiplexing without compromising throughput,” said Stephen Kulisch, Vice President of Marketing for Bio-Rad's Digital Biology Group. “This launch reflects our ongoing menu expansion in oncology and our commitment to providing oncology researchers with technologies that enable everything from biomarker discovery to clinical trials that support improvements in patient monitoring.” Kulisch continued, “We are pleased to announce this launch marking successful implementation of the license from NuProbe. We look forward to expanding our QX line of ddPCR assays with more launches for high-value cancer targets. With a sensitive assay menu available to our customers, the QX600 ddPCR System remains well suited to meet the needs of the oncology market from discovery to clinical research.” 

Bio-Rad is a market leader in digital PCR and provides complete solutions to the research and diagnostics communities, including instrumentation, software, reagents, and the most expansive menu of digital PCR assays on the market for applications spanning translational research, cell and gene therapy, and environmental monitoring. Droplet Digital PCR has been cited in over 8,300 publications, including more than 800 clinical research citations.