FRANKLIN LAKES, N.J.,
Sept. 23, 2020 /PRNewswire/
-- BD (Becton, Dickinson and Company) (NYSE: BDX), a
leading global medical technology company, today announced that it
has submitted a pre-market approval (PMA) supplement to the U.S.
Food and Drug Administration (FDA) for the use of the
ThinPrep® Pap Test™ PreservCyt® Solution
vial as an approved sample type for its BD Onclarity™ HPV
Assay.
The PMA supplement would expand the sample claims that can be
used in addition to the BD SurePath™ vial for the detection of
human papillomavirus (HPV) using the BD Onclarity™ HPV
Assay. The submission includes performance data for the BD
Viper™ LT and the BD COR™ Systems. An additional supplement was
submitted in January 2020 to seek
approval for the BD Onclarity™ HPV assay on the BD COR™ System and
the BD SurePath™ Liquid Based Cytology vial.
BD recently announced the FDA approval of a PMA supplement
that included the expansion for genotype reporting beyond HPV
genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58,
35/39/68, and 56/59/66 making the BD Onclarity™ HPV Assay the
only FDA-approved assay to individually identify and report these
genotype results.
"This PMA supplement to the FDA signifies BD's commitment to
expanding the availability of the BD Onclarity™ HPV Assay in the
U.S. to support better patient management by providing clinicians
more data to inform treatment decisions across multiple collection
devices," said Dave Hickey,
president of Integrated Diagnostic Solutions for BD. "BD is
dedicated to providing comprehensive screening solutions that are
accessible globally in the fight to eliminate cervical cancer."
About BD Onclarity™ HPV Assay
The BD
Onclarity™ HPV Assay detects and identifies 14 high-risk human
papillomavirus (HPV) types in a single analysis and provides
genotyping information from specimens collected for cervical cancer
screening purposes in the BD SurePath™ Collection Vial and in
the Hologic PreservCyt® Solution (not approved in
the United States). The assay is
for use in accordance with clinical guidelines and within the scope
of local regulatory authorizations as part of a comprehensive
approach to cervical cancer screening. The BD Onclarity™ HPV
Assay has FDA approval for clinical use in cytology-based screening
with ASC-US triage, in co-testing paradigm, and in primary HPV
screening. BD Onclarity™ HPV Assay has FDA approval for use in
vaccinated women. As the previously vaccinated subpopulation ages,
the screening population will progressively include women with
reduced prevalence of HPV 16 and 18, increasing the value of
extended genotype reporting in a mixed population of vaccinated and
unvaccinated women.7
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:
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Troy
Kirkpatrick
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Kristen
Stewart
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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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kristen.stewart@bd.com
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SOURCE BD (Becton, Dickinson and Company)