Strategic Collaborations in Molecular Residual Disease Monitoring of Cancer and Product Launches in ddPCR Portfolio Advance Corporate Strategy in H1 2024

HERCULES, Calif. — July 23, 2024 — Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B), a global leader in life science research and clinical diagnostic products, today provides an overview of advances supporting the Company’s overall corporate strategy to improve science and healthcare in the year to date. Centered on Bio-Rad’s Droplet Digital™ PCR (ddPCR™) solutions, achievements include strategic research collaborations with leading oncology institutions and health networks to enhance clinical monitoring of cancer patients, as well as expansion of the company’s product portfolio to support the increased use of Droplet Digital PCR across the biopharma and translational markets.

“We are delighted to report such significant advancements in the first half of the year, which exemplify Bio-Rad’s commitment to delivering innovative technologies and solutions that will drive the life sciences industry forward,” said Morgan Norris, Senior Vice President of Marketing, Bio-Rad Laboratories. “Bio-Rad’s collaborations with leading oncology institutions and health networks will be instrumental in establishing Droplet Digital PCR as a foundational technology for molecular residual disease monitoring, supporting our overarching strategy to advance scientific research and healthcare worldwide.”

Collaborations Leveraging Droplet Digital PCR to Advance Personalized Monitoring in Cancer Patients

Molecular residual disease (MRD) monitoring of cancer provides an indication of both remission and potential relapse, and is being increasingly adopted for the monitoring of solid tumors. Bio-Rad’s QX600™ Droplet Digital PCR System offers unmatched sensitivity, precision, and absolute quantification capabilities, and can be used by researchers to detect disease markers such as circulating tumor DNA, or ctDNA, earlier and more precisely than other commonly used technologies. Bio-Rad is reaching a comprehensive range of laboratories through its strategic collaborations — from academic centers to integrated health networks to service providers — with the goal of enabling clinical evidence generation using best-in-kind Droplet Digital PCR to advance precision oncology.

Bio-Rad is collaborating with Allegheny Health Network (AHN), an integrated health network with 14 hospitals, in an observational study using Droplet Digital PCR for tumor-informed MRD monitoring in patients with solid-tumor cancer following curative-intent treatment.

Bio-Rad is also collaborating with the Department of Molecular Medicine (MOMA) at Aarhus University Hospital in Denmark, which houses a close synergy between research and clinical activities, in a study incorporating the QX600 ddPCR System to generate clinical evidence for MRD monitoring post curative–intent treatment in patients with colorectal cancer. In a recent publication in the journal Annals of Oncology by the Aarhus lab (Henriksen et al, 2024), the commitment of the MOMA team to using ddPCR solutions for improved patient monitoring is illustrated citing “in conclusion using our personalized ddPCR approach for ctDNA detection of this large CRC cohort, we demonstrated the promise of identifying patients at high risk of recurrence post-operatively and serially during surveillance.”

Additionally, Bio-Rad continues to collaborate with Biodesix, a diagnostics solutions company with a focus on lung diseases, to develop and commercialize a pipeline of novel, highly multiplexed ddPCR oncology biomarker assays. Biodesix recently announced its use of Droplet Digital PCR in the evolution of its collaborative research agreement with the Memorial Sloan Kettering Cancer Center, driving forward advancements in cancer diagnostics and treatment. Droplet Digital PCR performed at Biodesix was recently featured in two publications in The New England Journal of Medicine and Annals of Oncology related to Johnson and Johnson’s MARIPOSA non-small-cell lung cancer trial, where ddPCR was used to measure cancer mutations in participating patient samples.

In addition to these oncology-focused partnerships, Bio-Rad announced a collaboration with Oncocyte, a precision diagnostics company, to use the QX600 Droplet Digital PCR System to develop and commercialize transplant monitoring tests, furthering the utility of Droplet Digital PCR for liquid biopsy applications.

Adoption of Droplet Digital PCR solutions in the market remains strong, with over 8,000 peer reviewed publications to date and notable customer successes, such as Geneoscopy’s ColoSense test gaining FDA approval for noninvasive colorectal cancer screening. ColoSense enables qualitative detection of RNA biomarkers for colorectal cancer and is designed for use with Bio-Rad’s FDA-cleared QXDxTM AutoDGTM ddPCR System.

Products to Support the Adoption of Droplet Digital PCR across Biopharma and Translational Research Sectors

Bio-Rad’s ddPCR solutions provide ultrasensitive nucleic acid detection and absolute quantification, with widespread applications across the biopharma and translational research sectors. In line with the growing demand for Droplet Digital PCR in these fields, Bio-Rad is dedicated to expanding its ddPCR portfolio with the introduction of highly relevant kits and assays.

In February, Bio-Rad announced the recent launch of the Vericheck ddPCR Replication Competent Lentivirus Kit and the Vericheck ddPCR Replication Competent AAV Kit. These kits provide rapid, cost-effective solutions for the absolute quantification of replication competent lentivirus (RCL) and replication competent adeno-associated virus (RCAAV), supporting the safe and effective production of cell and gene therapies. The kits are compatible with any of Bio-Rad’s Droplet Digital PCR Systems and join the Company’s growing portfolio of ddPCR assays for the biopharma market, including validated residual DNA detection kits for Mycoplasma, HEK293, E. coli, and CHO, as well as custom viral titer assays enabled by an online design portal.

Following this, in March, the ddPLEX ESR1 Mutation Detection Kit was introduced for the oncology research market. This kit is a powerful research tool that enables same-day and multiplexed detection, discrimination, and quantification of key ESR1 mutations, meeting the complex needs of laboratories developing ultrasensitive tests for breast cancer sample analysis. This product launch highlights the advanced multiplexing capabilities of the QX600 ddPCR System.

This month, Bio-Rad launched 50 new ddPCR Methylation Detection Assays, available through its Expert Design Program. These assays are available on the Company’s Digital Assays portal along with over 450,000 assays developed specifically for Droplet Digital PCR and supporting multiple applications for the translational research and biopharma markets.

A Global Gathering of ddPCR Users, Thought Leaders, and Visionaries

In June, Bio-Rad hosted Droplet Digital PCR World 2024. The two-day global virtual event explored best practices in ddPCR technology and its applications across diverse fields and industries. From molecular diagnostics to biopharmaceutical manufacturing, speakers presented recent achievements and advancements powered by Droplet Digital PCR technology.

The event featured 15 sessions with 13 speakers from Takeda, Merck, the Institute of Cancer Research, the Mayo Clinic, Verily (Google Life Sciences), and other renowned research facilities across the globe. Attendees had the opportunity to engage with speakers and ask questions about their research.

Additionally, there are ongoing Droplet Digital PCR World on Tour events taking place globally, including in Amsterdam, Barcelona, London, and Manchester. A separate virtual and in-person conference will be hosted on September 19–20, covering the Asia-Pacific region.

To access the on-demand event, register at bio-rad.com/ddPCRworld.

BIO-RAD, Droplet Digital, QX600 are trademarks of Bio-Rad Laboratories, Inc. in certain jurisdictions.