FRANKLIN LAKES, N.J.,
July 6, 2020 /PRNewswire/ -- BD
(Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, today announced that the U.S. Food and
Drug Administration (FDA) granted Emergency Use Authorization (EUA)
for a rapid, point-of-care, SARS-CoV-2 diagnostic test for use with
its broadly available BD Veritor™ Plus System. The launch of this
new assay that delivers results in 15 minutes on an easy-to-use,
highly portable instrument is critical for improving access to
COVID-19 diagnostics because it enables real-time results and
decision making while the patient is still onsite.
The BD Veritor™ System, which is slightly larger than a cell
phone, is currently in use at more than 25,000 hospitals, clinician
offices, urgent care centers and retail pharmacies in all 50 U.S.
states. Its one-button functionality, workflow flexibility, and
ease-of-use make it an ideal solution for settings without
laboratory personnel. It also offers customers real-time reporting
capabilities through the BD Synapsys™ informatics solution
providing them with the ability to easily report data for disease
monitoring and surveillance purposes.
BD is leveraging its global manufacturing network and scale and
expects to increase capacity to be able to produce 2 million tests
per week by the end of September. The company already expects to
produce up to 10 million tests from July through September.
"This will be a game-changer for frontline health care workers
and their patients to be able to access a quick diagnostic test for
COVID-19, offering results in real-time at convenient locations
like retail pharmacies, urgent care centers and doctors' offices,"
said Dave Hickey, president of
Integrated Diagnostic Solutions for BD. "Such tests will also help
communities be more informed and better prepared to help prevent
new spikes and additional waves of COVID-19 by enabling public
health workers to quickly identify infectious individuals and trace
their contacts. The highly portable, easy-to-use, point-of-care
format of this test, large quantity of test kits available and
existing, expansive footprint of BD Veritor™ Plus instruments will
help bring widespread access to COVID-19 testing in the United States and around the world as
additional country-specific regulatory requirements are
met."
The launch of the BD Veritor™ Plus System for Rapid Detection of
SARS-CoV-2 Assay is the latest effort in the company's
comprehensive response to address critical health needs related to
the global pandemic. The new immunoassay test joins a portfolio of
three molecular solutions for COVID-19 testing that have been
registered for use with the BD MAX™ Molecular
System, including two with EUAs and two with CE mark. So far
this year, the company has provided health care providers globally
with approximately 48 million swabs for flu and COVID-19 testing,
more than 2.85 million COVID-19 rapid molecular diagnostic tests on
the BD MAX™ System, and millions of products used in the treatment
of COVID-19 patients, including infusion pumps, infusion sets and
catheters.
All BD COVID-19 diagnostic products have regulatory
authorizations in the markets where they are sold. BD intends to
pursue 510(k) clearance for the BD Veritor™ Plus SARS-CoV-2 assay
from the FDA at a later time. U.S. customers interested in BD
diagnostic solutions for COVID-19 should contact
IDS.COVIDtests@bd.com.
About the BD Veritor™ SARS-CoV-2 Assay
The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2
Assay is deemed to be a CLIA-waived immunoassay designed to be used
in health care settings to provide an aid to rapid diagnosis of
COVID-19 in symptomatic individuals. BD clinical studies performed
at more than 20 sites across the U.S. demonstrated that the test is
capable of achieving 84% sensitivity and 100% specificity, which is
in line with the performance from similar immunoassay tests for Flu
A/B, RSV and Strep A on the BD Veritor™ Plus System — all of which
are widely-used, highly relevant and clinically valid. Similar to
all immunoassay tests, FDA recommends that negative test results be
confirmed by a molecular method to confirm the result, if
necessary, for patient management.
The BD point-of-care test has not been cleared or approved by
FDA. The test has been authorized by FDA under an EUA only for the
detection of SARS-CoV-2 nucleocapsid antigens to aid in the
diagnosis of SARS-CoV-2 virus infection. It has not been authorized
for use to detect any other viruses or pathogens. The test is
authorized in the United States
for the duration of the declaration that circumstances exist
justifying the authorization of emergency use of in vitro
diagnostic tests for detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the authorization is terminated or revoked sooner.
About BD
BD is one of the largest global medical technology companies in the
world and is advancing the world of health by improving medical
discovery, diagnostics and the delivery of care. The company
supports the heroes on the frontlines of health care by developing
innovative technology, services and solutions that help advance
both clinical therapy for patients and clinical process for health
care providers. BD and its 65,000 employees have a passion and
commitment to help enhance the safety and efficiency of clinicians'
care delivery process, enable laboratory scientists to accurately
detect disease and advance researchers' capabilities to develop the
next generation of diagnostics and therapeutics. BD has a presence
in virtually every country and partners with organizations around
the world to address some of the most challenging global health
issues. By working in close collaboration with customers, BD can
help enhance outcomes, lower costs, increase efficiencies, improve
safety and expand access to health care.
For more information on BD, please visit bd.com.
Forward Looking Statements
This press
release contains forward-looking statements regarding the use of
BD's point-of-care test and BD's manufacturing capacity.
Forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from those
expressed or implied in such statements, many of which are beyond
the company's control, including risks relating to market
acceptance of the test, events that could impact our manufacturing
capabilities, and other challenges inherent in manufacturing and
commercially launching new products. Further information on these
risks and uncertainties is included in the company's most recent
Annual Report on Form 10-K and other SEC filings. BD expressly
disclaims any undertaking to update any such statements set forth
herein to reflect events or circumstances after the date hereof,
except as required by applicable laws or regulations.
Contacts:
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Troy
Kirkpatrick
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Monique N. DoleckiBD
Public
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Relations
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BD
Investor
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Relations858.617.2361
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201.847.5378
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troy.kirkpatrick@bd.com
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Monique_Dolecki@bd.com
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SOURCE BD (Becton, Dickinson and Company)