FRANKLIN LAKES, N.J. and
BIRMINGHAM, Ala., April 3, 2020 /PRNewswire/ -- BD (Becton,
Dickinson and Company) (NYSE:
BDX), a leading global medical technology company, and BioGX Inc.,
a molecular diagnostics company, today announced that the U.S. Food
and Drug Administration (FDA) has granted Emergency Use
Authorization (EUA) for a new diagnostic test that will enable
hospitals to screen for COVID-19 (coronavirus) on site and get
results in under three hours.
The test helps fill an urgent need across the U.S. for hospitals
to access an easy-to-use, rapid diagnostic test to screen patients
and health care workers for COVID-19. The test will be run on the
BD MAX™ System, a molecular diagnostic platform already in use at
hundreds of laboratories in nearly every state across the country.
Each unit is capable of analyzing hundreds of samples per day.
"The BioGx molecular test for the BD MAX™ System and our
recently announced serology test that can help detect current and
past exposure to COVID-19 are part of BD's approach to give health
care workers choice and access to the right test for the right
situation," said Dave Hickey,
president of Integrated Diagnostic Solutions for BD. "We continue
to work diligently on an antigen test for our point-of-care BD
Veritor™ System that would complete a full portfolio of COVID-19
tests."
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. The BD MAX™ System can process 24 samples
simultaneously. The tests are expected to add capacity for 50,000
tests per week nationwide.
"The collaboration with BD, combined with the new emergency use
authorization process from FDA, enabled our companies to bring a
new test to the BD MAX™ System quickly and efficiently," said
Shazi Iqbal, Ph.D., chief executive
officer of BioGX. "The development and launch speed was critical to
ensure hospitals and laboratories can have additional options and
capacity for an automated, highly reliable SARS-CoV-2 test for
their patients."
BioGX developed the assay for the BD MAX™ System in their
Sample-Ready™ ready-to-use format to detect the presence of the
SARS-CoV-2 virus, the cause of COVID-19. 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 BioGX SARS-CoV-2 Reagents for the BD MAX™ System has not
been cleared or approved by FDA. However, it has been authorized by
the FDA under an EUA. The test has been authorized only for the
detection of RNA from SARS-CoV-2 virus to aid in the diagnosis of
SARS-CoV-2 virus infection, not for any other viruses or pathogens.
The test is only authorized 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.
About BioGX
BioGX, Inc., headquartered in Birmingham, Alabama, and its wholly owned
subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively
"BioGX"), develop and commercialize molecular diagnostics reagents
across diverse applications. BioGX operates in a cGMP
compliant environment certified to International Standard ISO
13485. The company applies its proprietary platform-agnostic
reagent technology to offer products and contract services across a
variety of real-time PCR and Next Generation Sequencing platforms.
The Sample-ReadyTM technology is at the core of all product
offerings for Clinical, Food Safety, Pharma and Water Quality
molecular testing. BioGX B.V.'s 50+ molecular diagnostic
products are marketed and sold in 100+ countries through its Global
Distribution Network. For more information on BioGX, please visit
BioGX.com.
Contacts:
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Troy
Kirkpatrick
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Monique N.
Dolecki
|
BD Public
Relations
|
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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Shazi
Iqbal
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BioGX
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205.250.8055
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shazi.iqbal@biogx.com
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SOURCE BD (Becton, Dickinson
and Company)