FRANKLIN LAKES, N.J.,
July 15, 2020 /PRNewswire/ -- BD
(Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, announced today a commitment from the
U.S. Department of Health and Human Services (HHS) to purchase BD
diagnostic solutions in expanding access to rapid point-of-care
testing for COVID-19 through a broad, decentralized network of
testing instrumentation.
HHS has committed to purchase 2,000 BD Veritor™ Plus Systems and
750,000 SARS-CoV-2 antigen test kits for use on the system.
Distribution is set to begin next week.
"The BD Veritor™ Plus System for rapid detection of SARS-CoV-2
is the latest point-of-care testing advance that will significantly
expand testing in distributed locations for the benefit of all
Americans," said Admiral Brett P.
Giroir, M.D., assistant secretary for Health and COVID-19
testing coordinator. "This development will help identify community
spread of the virus by further enabling rapid diagnosis of
COVID-19."
The U.S. Food and Drug Administration (FDA) granted BD an
Emergency Use Authorization (EUA) for its BD Veritor™ Plus System
for Rapid Detection of SARS-CoV-2 earlier this month. The test
leverages BD Veritor™ Plus Analyzers, portable instruments that are
slightly larger than a cell phone, which are already in use in 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 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.
"The ongoing pandemic has been devastating for individuals,
families and businesses around the world," said Dave Hickey, president of Integrated Diagnostic
Solutions for BD. "Until there is an effective treatment or
vaccine, rapid diagnostic testing is fundamental to controlling the
spread of the disease. The BD Veritor™ Plus Analyzers, SARS-CoV-2
antigen test kits, and BD Synapsys™ Informatics Solution will play
a critical role in helping clinicians identify individuals with
COVID-19 while helping public health officials track COVID-19
incidence and identify emerging outbreaks in real-time."
BD began shipping limited quantities of its BD Veritor™ Plus
SARS-CoV-2 antigen test kits to distributors last week as it ramps
up production capacity. 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 expects to produce up to 10 million tests from July through
September.
In addition to a SARS-CoV-2 antigen assay for the BD Veritor™
Plus System, BD and a network of partners offer a portfolio of
COVID-19 testing solutions including highly sensitive molecular
diagnostic tests on the BD MAX™ System. All BD COVID-19 diagnostic
products have EUA and BD intends to pursue 510(k) clearance with
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 Veritor™ Plus System for Rapid Detection of SARS-CoV-2
Assay has not been FDA cleared or approved. The test has been
authorized by FDA under an EUA for use by authorized laboratories.
This 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 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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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)