Bio-Rad Announces the Launch of a Serology Assay to Detect Coronavirus (COVID-19) Antibodies
April 07 2020 - 8:30AM
Business Wire
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
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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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Bio-Rad Laboratories, Inc. Tina Cuccia, Corporate Communications
510-724-7000 tina_cuccia@bio-rad.com
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