FRANKLIN LAKES, N.J. and
MORRISVILLE, N.C., March 31, 2020 /PRNewswire/ -- BD (Becton,
Dickinson and Company) (NYSE: BDX), a leading global medical
technology company, and BioMedomics, a privately held, North Carolina-based clinical diagnostics
company, today announced the release of a new point-of-care test
that can detect antibodies in blood to confirm current or past
exposure to COVID-19 in as little as 15 minutes.
The new test, developed and manufactured by BioMedomics, will be
available through BD and distributed exclusively by Henry Schein, Inc. to health care providers
throughout the United States.
The test does not require special equipment and may be used in a
laboratory or at the point of care. The test detects antibodies in
the blood that are produced by the body in response to coronavirus
infection. These antibodies are typically present in the middle to
later stages of COVID-19 infection, but may remain present after
exposure, which helps clinicians determine who has been exposed to
the coronavirus, even if a person didn't exhibit any symptoms of
the COVID-19 disease. Data on past exposure is important for
researchers to more accurately understand the likely true
occurrence of SARS-CoV-2 infection across a population. This
information will be helpful in informing future strategies for
combatting COVID-19.
"Serology tests are important because they provide an
additional piece of information to aid in characterizing possible
prior exposure to SARS-CoV-2, especially since many infections are
mild or asymptomatic in severity," said Dave Hickey, president of Integrated Diagnostic
Solutions for BD. "Initial evidence suggests that nearly all
patients infected with SARS-CoV-2 will have developed a detectable
antibody response within days of symptom onset, at which time a
negative serologic test, along with molecular diagnostics, could be
helpful in ruling out COVID-19. Our agreement with BioMedomics adds
a rapid serology test that can augment current tests already on the
market, and we are pleased to collaborate in this effort with
Henry Schein, which has extensive
knowledge of the point-of-care test field."
The test is completed in four, simple steps. First, blood is
collected through normal blood collection devices such as the BD
Microtainer® Contact-Activated Lancet. A
few drops of blood are then transferred to the test cartridge,
followed by two to three drops of a buffer. The results can be read
in 15 minutes, similar to how over-the-counter pregnancy tests show
multiple lines for positive results and a single line for negative
results.
"BioMedomics designed the test to be easy to use and provide
results in minutes, with no special equipment necessary or the need
to transport the sample to a laboratory for analysis," said
Frank Wang, CEO of BioMedomics. "Our
test has been clinically validated at several hospitals and
clinical laboratories in both the U.S. and China, and our published clinical data in the
Journal of Medical Virology was one of the world's first for
a COVID-19 serology test. It has been used widely in China during the COVID-19 outbreak and is now
ready to help combat coronavirus in the U.S. through our
collaboration with BD. We are committed to doing our part to battle
this disease and are excited to have BD as a partner to help
deliver our high-quality rapid test to those who need it most."
The test analyzes blood, serum or plasma samples for the
presence of immunoglobulin M (IgM) and Immunoglobulin G (IgG)
antibodies associated with the coronavirus (SARS-CoV-2). IgM
provides the first line of defense during viral infections,
followed by the generation of adaptive, high-affinity IgG responses
for long-term immunity and immunological memory. The detection of
COVID-19 IgM antibodies tends to indicate a recent exposure to
COVID-19, and detection of COVID-19 IgG antibodies indicates a
later stage of infection, so this combined antibody test could also
provide information on the stage of the disease in patients.
Current guidance from the U.S. Food and Drug Administration (FDA)
recommends that results from antibody testing should not be used as
the sole basis to diagnose or exclude coronavirus infection.
Depending on the clinical scenario, additional testing, such as
those used on the BD MAX™ System may be considered to further
evaluate the possibility of SARS-CoV-2 infection.
"We look forward to working with such an outstanding company as
BD to help make the antibody test part of the standard of care,"
said Stanley M. Bergman,
Henry Schein's chairman of the board
and chief executive officer. "The test will help to identify people
who have developed antibodies to the virus, which may inform future
strategies regarding COVID-19."
The test has not been reviewed by the FDA but is permitted for
distribution and use under the public health emergency guidance
issued by FDA on March 16, 2020, and
BD expects to begin shipping tests in April. BD will have capacity
to supply more than one million tests over the coming months, with
the ability to scale up based on market demand and is working with
medical products distribution company Henry
Schein to make these tests available to medical care
facilities throughout the United
States. Health care providers can order the test and all
collection devices needed to perform the test by contacting their
BD or Henry Schein
representatives.
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 BioMedomics
BioMedomics is a point-of-care
diagnostics company that aims to provide novel, rapid point-of-care
tests to aid in the diagnosis of critical diseases. The company
uses cutting-edge technology to create life-saving diagnostic
solutions and address global health care needs. Its diagnostic
tests produce rapid and accurate clinical results at the
point-of-care without requiring complex and expensive lab equipment
— placing immediate health care knowledge in the hands of
providers. With that knowledge comes the power to make treatment
decisions and save lives. Please visit biomedomics.com for more
information.
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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Kent
Lupino
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Ann Marie
Gothard
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BioMedomics
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Henry Schein,
Inc.
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984.464.3571
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631-390-8169
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klupino@biomedomics.com
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Annmarie.gothard@henryschein.com
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SOURCE BD (Becton, Dickinson and Company)