Bio-Rad Begins Shipping SARS-COV-2 (COVID-19) Antibody Test That Offers More Than 99 Percent Specificity & 98 Percent Sensiti...
21 April 2020 - 10:30PM
Business Wire
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader
of life science research and clinical diagnostic products, today
announced the commercial launch of its SARS-CoV-2 Total Ab test, a
blood-based immunoassay kit to help determine if an individual has
developed antibodies to SARS-CoV-2, the virus associated with
COVID-19 disease. Bio-Rad has applied for Emergency Use
Authorization offered by the U.S. Food and Drug Administration and
has met the CE mark requirements for Europe.
Bio-Rad’s SARS-CoV-2 Total Ab test can help clinicians identify
if an individual has been infected by SARS-CoV-2 and therefore has
developed an immune response against the virus. The test detects
IgG, IgM, and IgA antibodies, an approach that appears to be more
sensitive than assays against a single immunoglobulin1. Clinical
evaluation of the SARS-CoV-2 Total Ab test has demonstrated
diagnostic specificity of more than 99 percent and diagnostic
sensitivity of 98 percent. Cross-reactivity testing demonstrated
specificity of 100 percent with no reactivity against other
interfering specimens including non-CoV-2 coronaviruses.
Broad-based antibody testing can provide a more complete picture
of infection rates and immunity to help public health officials in
their efforts to reduce containment orders.
“We are pleased to introduce our SARS-CoV-2 Total Ab test to
support COVID-19 diagnosis and population screening,” said Dara
Wright, Bio-Rad Clinical Diagnostics Group EVP & President.
“Having applied for FDA Emergency Use Authorization and meeting the
requirements for CE marking, we have begun shipping the test and
are in the process of scaling up manufacturing to meet demand in
the weeks and months ahead,” she said.
The SARS-CoV-2 Total Ab test can be used manually or on an
automated immunoassay platform, such as Bio-Rad’s EVOLIS System,
which offers high throughput processing and sample
traceability.
To learn more about how Bio-Rad products are being used in the
fight against COVID-19, please visit our Newsroom at
bio-rad.com.
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 the duration and
severity of the COVID-19 pandemic, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200421005311/en/
Bio-Rad Laboratories, Inc. Tina Cuccia, Corporate Communications
510-724-7000 tina_cuccia@bio-rad.com
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