Assay for Research and Clinical Use Now
Globally Available for the BD MAX™ System
FRANKLIN
LAKES, N.J., Jan. 9, 2023
/PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a
leading global medical technology company, and CerTest Biotec have
announced Emergency Use Authorization (EUA) from the U.S. Food and
Drug Administration (FDA) for a molecular polymerase chain reaction
(PCR) assay for Mpox virus detection.
The VIASURE Monkeypox Virus Real Time PCR Reagents for BD MAX
System* is now available for BD MAX™ System users.
"The Mpox outbreak continues to be designated as a global health
emergency — the World Health Organization's highest level of
alert," said Nikos Pavlidis, vice
president of Molecular Diagnostics at BD. "The large
installed base of the BD MAX™ System in hospital labs provides
broad access to testing for a wide range of infectious diseases,
now including the mpox virus. EUA for the assay enables it to be
used for timely diagnosis and may help avert further global spread
of the disease."
The BD MAX™ System is a fully integrated, automated platform
that performs nucleic acid extraction and real-time PCR providing
results for up to 24 samples across multiple syndromes in less than
three hours. BD offers an extensive menu of tests on the system
covering health care associated infections, respiratory infections,
sexually transmitted infections, gastrointestinal infections and
women's health.
"We were able to quickly develop the VIASURE mpox molecular test
by leveraging the BD MAX™ System's open system reagent suite," said
Nelson Fernandes, managing director
of CerTest Biotec. "The EUA for the assay enables use for clinical
diagnosis of the disease, in addition to surveillance and the
research and development of vaccines and treatments."
As with all CerTest assays, the VIASURE Monkeypox Virus PCR
Detection assay for the BD MAX™ System is offered in a lyophilized
format. Accordingly, the assay will come in a tube that snaps into
the test-specific position on the BD MAX™ ExK™ TNA extraction
strip, which is supplied by BD.
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 77,000 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 or connect with us on LinkedIn at
www.linkedin.com/company/bd1/ and Twitter @BDandCo.
About CerTest
CerTest Biotec is a European company established in 2002 for the
development and manufacturing of in vitro diagnostic medical
devices. Today, CerTest is a global company structured around seven
business units offering one of the widest portfolios for human In
Vitro Diagnostic and Pharma. The company bases its future on a
strong technical knowledge and expertise in the detection of human
diseases. CerTest last generation laboratories, state-of-the-art
technical equipment and skilled professionals are the keys for
providing reliable solutions for the medical diagnostic
professional.
*This product has not been FDA cleared or approved, but has been
authorized for emergency use by FDA under an EUA for use by the
authorized laboratories; this product has been authorized only for
the detection of nucleic acid from monkeypox virus, not for any
other viruses or pathogens; and the emergency use of this product
is only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection and/or diagnosis of infection
with the monkeypox virus, including in vitro diagnostics that
detect and/or diagnose infection with non-variola
Orthopoxvirus, under Section 564(b)(1) of the Federal Food,
Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the
declaration is terminated or authorization is revoked sooner.
Contacts:
Media:
|
Investors:
|
Troy
Kirkpatrick
|
Francesca
DeMartino
|
VP, Public
Relations
|
SVP, Head of
Investor Relations
|
858.617.2361
|
201.847.5743
|
troy.kirkpatrick@bd.com
|
francesca.demartino@bd.com
|
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SOURCE BD (Becton, Dickinson and Company)