U.S. markets open in 1 minute

Bio-Rad Announces the Launch of a Serology Assay to Detect Coronavirus (COVID-19) Antibodies

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that the company is launching a blood-based immunoassay kit to identify antibodies to the coronavirus SARS-CoV-2, the virus associated with COVID-19. Preliminary performance of the assay has been established and the kit is now undergoing clinical evaluation in several hospitals to further confirm clinical performance. Initial data collected on more than 700 samples has demonstrated specificity above 99 percent.

After infection with SARS-CoV-2, viral antigens stimulate the body’s immune system to produce antibodies to fight the virus. Bio-Rad believes its blood-based immunoassay kit will help clinicians determine if an individual has been infected by the virus and therefore has developed an immune response against SARS-CoV-2.

"Using a serology test to support the diagnosis of COVID-19 and to screen populations can provide a more complete understanding of infection rates as well as immunity," said Dara Wright, Bio-Rad Clinical Diagnostics Group EVP & President. "The detection of antibodies to SARS-CoV-2 on a large scale may be used to guide public authorities in their decisions to lift partial or total containment orders according to the serological status of the population. Molecular and serology testing are highly complementary in this regard," she said.

Bio-Rad’s immunoassay kit detects total immunoglobulin (IgG, IgM, and IgA), an approach which appears to be more sensitive than assays against a single immunoglobulin1. The test was designed for use manually or on an automated immunoassay platform, such as Bio-Rad’s EVOLIS System, which offers high throughput processing and sample traceability.

Bio-Rad plans to offer the immunoassay kit globally. In the United States, the company intends to use the FDA’s Emergency Use Authorization process to expedite U.S. availability.

To learn more about how Bio-Rad products are being used in the fight against COVID-19, please visit our Newsroom at https://www.bio-rad.com/en-us/corporate/newsroom?ID=1006

1https://doi.org/10.1101/2020.03.02.20030189

BIO-RAD and EVOLIS are trademarks of Bio-Rad Laboratories, Inc., in certain jurisdictions.

About Bio-Rad

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) is a global leader in developing, manufacturing, and marketing a broad range of innovative products for the life science research and clinical diagnostic markets. With a focus on quality and customer service for over 65 years, our products advance the discovery process and improve healthcare. Our customers are university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality. Founded in 1952, Bio-Rad is based in Hercules, California, and has a global network of operations with more than 8,100 employees worldwide. Bio-Rad had revenues exceeding $2.3 billion in 2019. For more information, please visit bio-rad.com.

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 regarding 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 our ability to develop and market new or improved products, our ability to compete effectively, international legal and regulatory 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200407005285/en/

Contacts

Bio-Rad Laboratories, Inc.
Tina Cuccia, Corporate Communications
510-724-7000
tina_cuccia@bio-rad.com