FRANKLIN LAKES, N.J.,
July 30, 2020 /PRNewswire/ -- BD
(Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, today announced a $24 million investment from the U.S. Department
of Defense in collaboration with the U.S. Department of Health and
Human Services to support the scale up of U.S. manufacturing
capabilities for BD Veritor™ Solution for Rapid Detection of
SARS-CoV-2 (see demo here).
The additional capital equipment will bolster domestic
production and increase total production capacity by 50 percent.
These investments will enable global production of more than 12
million test kits per month by the end of February 2021.
"Making COVID-19 diagnostic tests widely available is critical
to expanding rapid detection of COVID-19 infections, and mitigating
the impact of the disease by identifying affected patients, quickly
quarantining infectious individuals and tracing their contacts,"
said Dave Hickey, president of
Integrated Diagnostic Solutions for BD. "This investment will
bolster our U.S. manufacturing capabilities helping us quickly
scale our production of point-of-care COVID-19 tests to ensure we
have a robust supply for our U.S. customers."
BD announced that it had received FDA emergency use
authorization for the BD Veritor™ Plus SARS-CoV-2 antigen assay on
July 6, 2020 and plans to leverage
its growing U.S. installed base of more than 25,000 BD Veritor™
Plus instruments to enable the deployment of the SARS-CoV-2 assay
across the U.S. The easy-to-use design of the instrument, slightly
larger than a cell phone, makes it ideal for use in a variety of
clinical settings including hospitals, clinician offices, urgent
care centers, and retail pharmacies, where it has already been used
in influenza, group A strep and RSV testing for several years.
U.S. customers interested in BD diagnostic solutions for
COVID-19 should visit BD.com/covid19 or 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 Veritor™ Plus System for Rapid Detection
of SARS-CoV-2 Assay has not been cleared or approved by FDA.
The test has been authorized by FDA under an EUA
for use by authorized laboratories. The test has
been authorized only for the detection of proteins from SARS-CoV-2,
not for any other viruses or pathogens; and, the test is
only authorized for the duration
of the declaration that circumstances exist
justifying the authorization
of emergency use of in vitro diagnostics
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, visit bd.com.
Forward Looking Statements
This press release contains certain forward-looking statements
regarding the manufacturing of the BD Veritor™ COVID-19 diagnosic
test. 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 these risks
and uncertainties are beyond the company's control, including
without limitation, disruptions caused by the coronavirus pandemic
and other factors listed in our 2019 Annual Report on Form 10-K and
other filings with the SEC. BD expressly disclaims any
undertaking to update any forward looking 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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Gwen
Gordon
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Monique N.
Dolecki
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BD Public
Relations
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BD Investor
Relations
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858.352.8462
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201.847.5378
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gwen.gordon@bd.com
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monique_dolecki@bd.com
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SOURCE BD (Becton, Dickinson and Company)