FRANKLIN LAKES, N.J.,
Feb. 22, 2017 /PRNewswire/
-- Effective Feb. 13, 2017, the
Food and Drug Administration (FDA) has reclassified antigen based
rapid influenza virus antigen detection systems (RIDTs) intended to
detect influenza virus directly from clinical specimens from Class
I devices into Class II devices subject to special controls.
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, today announced that its BD Veritor™
System Flu A+B, a digital immunoassay for the rapid detection of
influenza, meets the new FDA performance requirements.
i
Prompting these changes was the inadequate performance of some
point-of-care flu tests available during the 2009 flu pandemic,
which raised concerns regarding the accuracy of detecting influenza
in patients. With the new FDA requirements,i rapid flu
tests, which are used by health care providers and laboratory
personnel, must now attain a higher level of performance.
"The change to the new performance standards may help improve
the overall quality of testing for influenza," said Dr.
Charles Cooper, vice president of
medical affairs at BD. "This agency's decision has the potential to
improve patient outcomes — ensuring that the tools health care
providers use for diagnosing influenza meet new, higher standards
for accuracy. As we know, an accurate diagnosis helps to determine
appropriate use of antiviral medications, while at the same time
reducing inappropriate over-prescription of antibiotics, which can
only help in the fight against antimicrobial resistance."
As part of the new reclassification of rapid flu tests from
Class I to Class II, the FDA is raising the tests to higher
performance standards. This change will help to ensure that health
care providers and allied health professionals who use rapid flu
tests to detect influenza viruses will have quick access to more
accurate information.
In recognizing the need to improve diagnostics, BD developed and
launched the BD Veritor System for Rapid Detection of Flu A+B. This
was the first Clinical Laboratory Improvement Amendments
(CLIA)-waived flu test that provides objective results on an
easy-to-read digital display. The now Class II BD Veritor System
Flu A+B test became available in 2011, and is the same test used on
the new BD Veritor Plus System, a next generation wireless rapid
diagnostic system for detection of influenza A and B, respiratory
syncytial virus (RSV) and group A strep.
More information about the FDA reclassification and the BD
Veritor Plus System are available at
http://www.bd.com/ds/VeritorSystem or through BD Technical Service
at 800.638.8663.
About BD
BD is a global medical technology company
that is advancing the world of health by improving medical
discovery, diagnostics and the delivery of care. BD leads in
patient and health care worker safety and the technologies that
enable medical research and clinical laboratories. The company
provides innovative solutions that help advance medical research
and genomics, enhance the diagnosis of infectious disease and
cancer, improve medication management, promote infection
prevention, equip surgical and interventional procedures, and
support the management of diabetes. The company partners with
organizations around the world to address some of the most
challenging global health issues. BD has more than 40,000
associates across 50 countries who work in close collaboration with
customers and partners to help enhance outcomes, lower health care
delivery costs, increase efficiencies, improve health care safety
and expand access to health. For more information on BD, please
visit bd.com.
iMicrobiology Devices; Reclassification of Influenza
Virus Antigen Detection Test Systems Intended for Use Directly With
Clinical Specimens, 82 Fed. Reg. 3609 (January 12, 2017)
https://www.federalregister.gov/documents/2017/01/12/2017-00199/microbiology-devices-reclassification-of-influenza-virus-antigen-detection-test-systems-intended-for.
Contacts:
|
|
Troy
Kirkpatrick
|
Monique N.
Dolecki
|
BD Public
Relations
|
BD Investor
Relations
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858.617.2361
|
201.847.5378
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troy.kirkpatrick@bd.com
|
monique_dolecki@bd.com
|
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SOURCE BD (Becton, Dickinson and Company)