FRANKLIN LAKES, N.J.,
April 13, 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) has granted Emergency Use
Authorization (EUA) for an additional molecular diagnostic test for
COVID-19 that can return results in two to three hours. The new
test also has been CE marked to the IVD Directive (98/79/EC).
The test, which is run on the BD MAX™ System, provides
additional testing capacity for COVID-19 in the United States and in countries that
recognize the CE Mark to test patients and health care workers. The
test is in addition to the other tests already available on the BD
MAX™ System from collaborations with BioGX and CerTest and is based
on the CDC assay design. The BD MAX™ System, a molecular diagnostic
platform, is already in use at thousands of laboratories worldwide,
and each unit is capable of analyzing hundreds of samples over a
24-hour period.
"The new BD COVID-19 test for the BD MAX™ System will help
increase availability of these much-needed tests around the world,"
said Dave Hickey, president of
Integrated Diagnostics for BD. "We continue to work towards a full
portfolio of testing options to give health care workers choice and
access to the right test for the right situation."
The majority of BD MAX™ Systems are installed in hospital
laboratories, reducing the added time and complexity of needing to
send samples to a reference lab. The system is fully automated,
reducing the opportunity for human error and increasing the speed
to result, and can process 24 samples simultaneously. The assay is
based on the same viral RNA targeting sequences and real-time PCR
detection method as the test developed by the U.S. Centers for
Disease Control and Prevention (CDC).
Hospitals and laboratories that use a BD MAX™ System can order
tests through their BD sales representative.
The BD SARS-CoV-2 Reagent Kit for BD MAX™ System has been CE
marked to the IVD Directive (98/79/EC), but it has not been cleared
or approved by FDA. The test has been authorized by FDA under an
EUA only for the detection of RNA from SARS-CoV-2 virus 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.
Contacts:
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Troy
Kirkpatrick
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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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858.617.2361
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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)