SARS-CoV-2 Assay for BD Veritor™ Plus System to be
available in Europe by end of
October
FRANKLIN LAKES, New Jersey,
Sept. 30, 2020 /PRNewswire/ -- BD
(Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, today announced its rapid,
point-of-care, SARS-CoV-2 antigen test for use on the BD Veritor™
Plus System has been CE marked to the IVD Directive (98/79/EC).
The new test delivers results in 15 minutes on an easy-to-use,
portable instrument, which is a critical improvement in turnaround
time for COVID-19 diagnostics, because it provides real-time
results and enables decision-making while the patient is still
onsite. The company expects commercial availability of this new
assay at the end of October for countries in Europe that recognize the CE mark.
"Availability of the SARS-CoV-2 assay on the BD Veritor™ Plus
System in Europe builds on our
molecular test on the BD MAX™ System that has been available since
March," said Roland Goette,
president of BD EMEA Region. "The addition of a truly portable,
point-of-care test that can deliver results while the patient waits
will be welcomed by health care providers and patients alike to
help protect against additional waves of COVID-19."
The test, which has been available in the United States since July through an
Emergency Use Authorization by the U.S. Food and Drug
Administration (FDA), uses the BD Veritor™ Plus System, which is
already in use across Europe to
test for conditions such as Group A Strep, influenza A+B and
Respiratory Syncytial Virus (RSV). The BD Veritor™ Plus System,
which is slightly larger than a mobile phone, offers an easy-to-use
workflow that makes it an ideal solution for point-of-care
settings. It also offers customers traceability and reporting
capabilities through the optional BD Synapsys™ informatics
solution.
The European Centre for Disease Prevention and Control (ECDC)
recently released guidance that all patients with acute respiratory
symptoms should be tested for both SARS-CoV-2 and influenza A+B in
parallel during flu season1. The BD Veritor™ Plus System
can test for both infections on the same platform.
BD is leveraging its global manufacturing network and scale to
produce 8 million SARS-CoV-2 antigen tests per month by October and
expects to produce 12 million tests per month by March 2021.
For Product Enquiries and How to Order:
All BD SARS-CoV-2 diagnostic products have regulatory
authorizations in the markets where they are sold. European
customers interested in BD diagnostic solutions for SARS-CoV-2
should visit bd.com/VeritorSystem-EU or contact BD's local customer
service.
About the BD Veritor™ System for Rapid Detection of
SARS-CoV-2 Assay
The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay
has been CE marked to the IVD Directive (98/79/EC), but 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. The BD Veritor™
Plus System for Rapid Detection of SARS-CoV-2 Assay is not
authorized for use by consumers or for at-home use.
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.
1
https://www.ecdc.europa.eu/en/covid-19/surveillance/testing-strategies
Contacts:
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Troy
Kirkpatrick
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Kristen
Stewart
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BD Public
Relations
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BD Investor
Relations
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858.617.2361
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201.847.5378
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troy.kirkpatrick@bd.com
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kristen.stewart@bd.com
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Tracey
Bowditch
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For BD
Europe
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TBowditch@RuderFinn.co.uk
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