Bio-Rad Launches Vericheck ddPCR Replication Competent Lentivirus and Replication Competent AAV Kits for Cell and Gene Therapy Production

Rapid, Sensitive, and Validated Detection of Viral Replication Genes Using Droplet Digital™ PCR During Cell and Gene Therapy Production

HERCULES, Calif. — February 27, 2024 — Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B), a global leader in life science research and clinical diagnostics products, today announced the recent launch of the Vericheck ddPCR™ Replication Competent Lentivirus Kit and the Vericheck ddPCR Replication Competent AAV Kit. The 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.

Replication competent viruses (RCVs) can infect cells and replicate to produce additional virions. RCVs can be generated through recombination events between the transfer plasmid and either the production plasmids or the packaging cell line's genome. Fundamental to the safety of emerging cell and gene therapies, RCV testing of samples must be performed throughout the production process.

Bio-Rad’s Vericheck ddPCR kits for detection of RCL and RCAAV provide a validated solution for highly specific and highly sensitive detection and quantification of viral replication genes, potentially indicating an RCV. The tests are designed for Bio-Rad's QX Droplet Digital PCR (ddPCR) platforms, with a simple workflow including automated data analysis and flexible sample throughput. Compared to traditional cell culture–based methods for RCV testing, the kits significantly reduce cost and turnaround time, achieving results in as little as 8 hours.

“As the number of cell and gene therapies entering the market increases, we see a growing emphasis on the need for products to ensure safety and efficacy across production processes. We believe that Droplet Digital PCR solutions can help address this unmet need,” said Carolyn Reifsnyder, Senior Director of Marketing at Bio-Rad. “The introduction of Bio-Rad’s newest Vericheck ddPCR kits for RCL and RCAAV to our growing portfolio reflects our ongoing commitment to providing innovative QC tools to support advances in the cell and gene therapy space.”

To learn more about the Vericheck ddPCR kits for RCL and RCAAV detection, visit bio-rad.com/ddPCR-Vericheck-RCV.

BIO-RAD and Droplet Digital 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 bio-rad.com.