FRANKLIN LAKES, N.J. and
BIRMINGHAM, Ala., March 16, 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 companies
have submitted Emergency Use Authorization requests to the U.S.
Food and Drug Administration (FDA) for new diagnostic tests
that, if authorized, would increase
the potential capacity to screen for COVID-19 (coronavirus) by
thousands of tests per day.
The tests would help fill an urgent need across the U.S. for
laboratories to access an easy-to-use, rapid diagnostic test to
screen patients for COVID-19. The tests will be run on the BD MAX™
Molecular Diagnostic Platform, which is already in use in nearly
every state across the U.S. at hundreds of laboratories, with each
unit capable of analyzing hundreds of samples per day. The system
is fully automated, reducing the opportunity for human error and
increasing the speed to result. Samples are capable of being
analyzed start to finish in two to three hours. Each BD MAX™ System
can process 24 samples simultaneously.
"The collaboration with BioGX to deliver a COVID-19 diagnostic
in the U.S. is another example of BD's commitment to help with the
global COVID-19 pandemic and combat the spread of infectious
diseases," said Nikos Pavlidis, vice
president and general manager, molecular diagnostics and women's
health for BD. "Our BD MAX System is a versatile molecular platform
that enables us to rapidly deliver molecular solutions across our
laboratory customers and help communities in need during times of
high anxiety."
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).
"These are challenging times for all of us, more so for our
laboratory partners who have an urgent need for an easy to use,
reliable test to detect the SARS-CoV-2 to determine if patients
have contracted COVID-19," said Shazi
Iqbal, Ph.D., chief executive officer of BioGX. "The
foundation of BioGX firmly stands on its team's ability to step up
and address such unmet needs with speed. Authorization to use
our test would increase access across the U.S. to an automated,
highly reliable SARS-CoV-2 test."
The companies submitted the Emergency Use Authorization requests
to FDA today. The Emergency Use Authorization authority allows FDA
to help strengthen the nation's public health protections against
chemical, biological, radiological and nuclear threats by
facilitating the availability and use of medical countermeasures
needed during public health emergencies.
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:
|
|
Troy
Kirkpatrick
|
Monique N.
Dolecki
|
BD Public
Relations
|
BD Investor
Relations
|
858.617.2361
|
201.847.5378
|
troy.kirkpatrick@bd.com
|
Monique_Dolecki@bd.com
|
|
|
Shazi
Iqbal
|
|
BioGX Corporate
Development
|
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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)