FRANKLIN LAKES, N.J.,
Dec. 20, 2018 /PRNewswire/ -- BD
(Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, today announced the U.S. Food and Drug
Administration 510(k) clearance of its BD MAX™ enteric viral panel,
a molecular diagnostic test for the direct qualitative detection
and differentiation of enteric viral pathogens that cause viral
gastroenteritis. The company now offers a broad suite of solutions
for the detection of intestinal conditions of bacterial, viral, and
parasitic origin, in clinically relevant, targeted panels.
Acute viral gastroenteritis can be contracted by virtually any
patient and spread within close community settings such as daycare
centers, nursing facilities, and cruise ships. Norovirus is
the most common viral cause and accounts for 19 to 21 million cases
of diarrheal illness annually in the
United States, and 50 percent of all foodborne diarrheal
outbreaks. Other viral causes include rotavirus, adenovirus,
astrovirus and sapovirus to varying degrees of prevalence.
Diagnosing the underlying cause of diarrhea can play a critical
role in patient management to isolate patients at risk of spreading
infectious diarrhea to others and rule out other causes of
infection in children, the elderly or immunocompromised
patients.
The BD MAX™ enteric suite of molecular tests for the detection
of gastrointestinal bacteria, parasitic or viral pathogens enable
clinicians to perform targeted testing for patients based upon
their symptoms and health history or exposure. This testing
approach is supported by the Infectious Diseases Society of America
(IDSA) guidelines. Compared to more generalized tests, this test
provides the most clinically useful and necessary information to
better diagnose and treat patients.
The BD MAX ™ enteric viral panel is designed for targeted
detection of the viral cause of infectious diarrhea symptoms in all
care settings and can detect norovirus, rotavirus, adenovirus,
human astrovirus, and sapovirus.
The enteric panels run on the BD MAX™ molecular system and can
return results in less than 3.5 hours, dramatically shortening time
to results over traditional test methods. This shortened time to
results allows clinicians to more quickly understand the cause of
the patient's illness.
"We continue to expand our menu of unique, clinically relevant,
molecular diagnostics panels to aid in diagnosis of a range of
infectious diseases," said Nikos
Pavlidis, vice president and general manager of Molecular
Diagnostics & Women's Health for BD. "With this launch, BD's
suite of assays for diagnosing gastrointestinal conditions will
provide clinicians with greater flexibility for more efficient and
cost-effective patient management. We also offer panels for
diagnosis of hospital acquired infections including C. diff and
MRSA as well as vaginal infections, common sexually transmitted
infections, and group B streptococcal disease."
About BD MAX™ MOLECULAR
SYSTEM
The BD MAX™ system is a fully-integrated,
automated molecular diagnostics platform that performs nucleic acid
extraction and real-time PCR. The system can multiplex up to 24
samples across multiple test applications and provide test results
for most assays in less than three hours. Using BD MAX™ products,
laboratories can test for a range of conditions including women's
health and sexually transmitted infections, enteric conditions, and
healthcare associated infections.
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
healthcare by developing innovative technology, services and
solutions that help advance both clinical therapy for patients and
clinical process for healthcare 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 healthcare. In 2017, BD welcomed C. R. Bard and its
products into the BD family. For more information on BD, please
visit bd.com.
Contacts:
|
|
Gwen
Gordon
|
Monique N.
Dolecki
|
BD Public
Relations
|
BD Investor
Relations
|
858.812.3724
|
201.847.5378
|
gwen.gordon@bd.com
|
monique_dolecki@bd.com
|
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SOURCE BD (Becton, Dickinson and Company)