Bio-Rad Announces Collaboration Agreement with Oncocyte to Commercialize Transplant Monitoring with Droplet Digital PCR

Date: 
2024-04-12

Hercules, California — Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B) a global leader in life science research and clinical diagnostics products, today announced a collaboration agreement with Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, to develop and commercialize transplant monitoring products using Bio-Rad’s Droplet Digital™ PCR (ddPCR™) instruments and reagents.

Under the terms of the agreement, Bio-Rad has committed to participate in a private placement of Oncocyte’s equity and has secured exclusive commercial rights in certain markets to commercialize Oncocyte’s assay for transplant monitoring research using Bio-Rad’s QX600™ ddPCR System.

Transplanted organs release cell-free DNA into the bloodstream of the recipient. This donor-derived cell-free DNA (dd-cfDNA1) is a sensitive biomarker for organ health that requires only a simple blood draw. The novel approach developed by the team at Oncocyte allows the assay to be applied to clinical research of both recent and non-recent transplants. The utility of the ddPCR-based approach has been well demonstrated, including in a prospective, observational, multicenter cohort trial published in 2017, which showed earlier and more sensitive discrimination of liver transplant patients with acute rejection, compared to conventional liver functional test methods2.

Oncocyte’s transplant monitoring assays and the Bio-Rad QX600 ddPCR System provide a highly sensitive and decentralized solution that could provide a more attractive alternative for laboratories that currently rely on centralized next-generation sequencing (NGS) test providers.

Commenting on the collaboration, Simon May, EVP and President of Life Sciences at Bio-Rad Laboratories, stated: “This collaboration advances Bio-Rad’s strategy to establish Droplet Digital PCR as a foundational technology by providing researchers and laboratories with high-value assays across a variety of life science applications. We believe that Oncocyte’s transplant monitoring assays and the Bio-Rad QX600 ddPCR System solution for the noninvasive measurement and quantification of key biomarkers used in solid tissue transplant monitoring research has the potential to advance science and save lives.”

To learn more about Bio-Rad’s ddPCR technology visit bio-rad.com/qx600system

  1. Donor-derived cell-free DNA (dd-cfDNA) is also known as graft-derived cell-free DNA (GcfDNA)
  2. Schütz E et al. (2017). Graft-derived cell-free DNA, a noninvasive early rejection and graft damage marker in liver transplantation: A prospective, observational, multicenter cohort study. PLoS Med 14, e1002286

Bio-Rad, ddPCR, Droplet Digital and QX600 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.

Forward-Looking Statements
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 our expectations about our products and believing that Oncocyte’s transplant monitoring assays and the Bio-Rad QX600 ddPCR System solution for the noninvasive measurement and quantification of key biomarkers used in solid tissue transplant monitoring research has the potential to advance science and save lives. 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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