Bio-Rad Launches First Ultrasensitive Multiplexed Digital PCR Assay for Breast Cancer Mutation Detection in Clinical Research

ddPLEX ESR1 Mutation Detection Kit

ddPLEX ESR1 Mutation Detection Kit

HERCULES, Calif.—Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), 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, announced by the two companies 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.

To learn more about the ddPLEX ESR1 Mutation Detection Kit, visit

BIO-RAD, QX600, DROPLET DIGITAL, and DDPCR are trademarks of Bio-Rad Laboratories, Inc. in certain jurisdictions.

About Bio-Rad
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B) is a leader in developing, manufacturing, and marketing a broad range of products for the life science research and clinical diagnostics markets. Based in Hercules, California, Bio-Rad operates a global network of research, development, manufacturing, and sales operations with over 8,000 employees and $2.7 billion in revenues in 2023. Our customers include universities, research institutions, hospitals, food safety and environmental quality laboratories, and biopharmaceutical companies. Together, we develop innovative, high-quality products that advance science and save lives. To learn more, visit

This release may be deemed to contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements we make regarding looking forward to expanding our QX line of ddPCR assays with more launches for high-value cancer targets, and regarding our products and our expectations about our products. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "plan", "believe," "expect," "anticipate," "may," "will," "intend," "estimate," "continue," or similar expressions or the negative of those terms or expressions, although not all forward-looking statements contain these words. Such statements involve risks and uncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. These risks and uncertainties include global economic and geopolitical conditions, our ability to develop and market new or improved products, our ability to compete effectively, international legal and regulatory risks, supply chain risks, and product quality and liability issues. For further information regarding our risks and uncertainties, please refer to the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" in Bio-Rad's public reports filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. Bio-Rad cautions you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

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