Bio-Rad Receives FDA Emergency Use Authorization for Droplet Digital PCR SARS-CoV-2 Test Kit
May 04 2020 - 7:27PM
Business Wire
Bio-Rad Laboratories Inc. (NYSE: BIO and BIOb), a global leader
of life science research and clinical diagnostic products, today
announced that its SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit
has been granted Emergency Use Authorization (EUA) by the U.S. Food
and Drug Administration (FDA). The SARS-CoV-2 Droplet Digital PCR
(ddPCR) test runs on Bio-Rad’s QX200 and QXDx ddPCR systems.
The high sensitivity of the test makes it well suited to
screening upper respiratory samples in patients with a low viral
load, including individuals in the early stages of infection as
compared to classical quantitative PCR tests. The test can also
play an important role in surveillance by detecting minimal
residual disease in people recovering from COVID-19 informing them
if they are negative for the virus. Bio-Rad’s single-well
SARS-CoV-2 ddPCR test provides clinicians with a high degree of
sensitivity that can significantly improve the accuracy of reported
results.
According to the World Health Organization, regular, accurate
testing of COVID-19 is a key component in the fight against the
global pandemic.
“We are pleased to receive Emergency Use Authorization for our
SARS-CoV-2 ddPCR test that offers high sensitivity in detecting
infection of COVID-19 at an early stage,” said Simon May, Senior
Vice President of Bio-Rad’s Digital Biology Group. “We believe the
test will be a powerful complement to current diagnostics, helping
clinicians and public health officials accurately identify infected
individuals in a timely manner. With the EUA, our test is now
available to clinical labs in the U.S.,” he said.
Thousands of hospitals and molecular testing labs in the U.S.
and around the world have Bio-Rad’s QX200 and QXDx ddPCR systems
installed and have the capacity to perform SARS-CoV-2 ddPCR
testing. The SARS-CoV-2 ddPCR test represents the latest addition
to Bio-Rad’s product offerings related to COVID-19. This is the
second EUA Bio-Rad has been granted for COVID-19. Last week, the
company received an EUA for a serology test to detect antibodies to
the virus.
BIO-RAD, DROPLET DIGITAL PCR, and ddPCR, 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.
The SARS-CoV-2 ddPCR Test Kit has been authorized for emergency
use by FDA under an EUA as described in this document.
This device is authorized only for the duration of the
declaration that circumstances exist justifying the authorization
of the emergency use of the SARS-CoV-2 ddPCR Test Kit under Section
564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §
360bbb- 3(b)(1), unless the authorization is terminated or revoked
sooner.
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 belief that
our SARS-CoV-2 ddPCR test will be a powerful complement to current
diagnostics, helping clinicians and public health officials
accurately identify infected individuals in a timely manner, and
regarding our expectations about 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/20200504005792/en/
Bio-Rad Laboratories, Inc. Tina Cuccia, Corporate Communications
510-724-7000 tina_cuccia@bio-rad.com
Bio Rad Laboratories (NYSE:BIO)
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