FRANKLIN LAKES, N.J.,
Nov. 12, 2019 /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 an expanded version of its
BD Onclarity™ HPV Assay.
The FDA-approved BD Onclarity™ HPV Assay detects 14 types of
high-risk human papillomavirus (HPV) from specimens collected for
cervical cancer screening in the BD SurePath™ Collection Vial.
The BD Onclarity™ HPV Assay is the only
FDA-approved assay to individually identify and report
HPV genotypes 16, 18, and 45. These genotypes are associated
with the majority of cervical cancers worldwide and are
disproportionally responsible for up to 94 percent of glandular
cervical pre-cancer cases.1,2 The prevalence of HPV
genotypes 16 and 18, which are among those targeted by the
FDA-approved HPV vaccines, are decreasing in vaccinated
populations; thus shifting the prevalence of cervical pre-cancer
cases to other HPV genotypes.3
The PMA supplement seeks approval for genotype reporting beyond
HPV genotypes 16, 18, and 45 to include types 31, 51, 52, and 8
additional types. The FDA submission includes data collected during
a three year follow up of subjects from BD's prospective,
multi-center clinical trial conducted in the U.S. that included
more than 33,500 women, including those who received HPV vaccines
and those who did not.
"Our goal is to provide laboratories and clinicians worldwide
with comprehensive cervical cancer screening solutions that address
the unique needs of individual healthcare providers and precision
medicine for patients," said Dave
Hickey, president, BD Integrated Diagnostic Solutions. "This
PMA submission is the next step in our roadmap for the BD women's
health and cancer portfolio as it brings us one step closer to
expanding access to extended HPV genotyping capabilities in the
U.S. market."
About BD Onclarity™ HPV Assay
The BD Onclarity™ HPV Assay detects and
identifies 14 high-risk human papillomavirus (HPV) types 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 can be used in
accordance with clinical guidelines and within the scope of local
regulatory authorizations as part of a comprehensive approach to
cervical cancer prevention. Different configurations of the test
are CE marked and FDA approved.
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.
References
1. de Sanjose S, Quint WG, Alemany L, Geraets DT,
Klaustermeier JE, et al. (2010). Human papillomavirus genotype
attribution in invasive cervical cancer: a retrospective
cross-sectional worldwide study. The Lancet Oncology, 11(11):
1048-56.
2. Li N, Franceschi S, Howell-Jones R, Snijders P J &
Clifford GM. (2011). Human papillomavirus type distribution in
30,848 invasive cervical cancers worldwide: Variation by
geographical region, histological type and year of publication.
International Journal of Cancer, 128(4), 927-35.
3. Wright Jr TC, Parvu V, Stoler MH, Kodsi S, Eckert K,
Yanson K, Cooper CK. (2019). HPV infections and cytologic
abnormalities in vaccinated women 21–34 years of age: Results from
the baseline phase of the Onclarity trial. Gynecologic Oncology,
153:259-265.
Contacts:
Gwen
Gordon
|
Monique N.
Dolecki
|
BD Public
Relations
|
BD Investor
Relations
|
858.617.2897
|
201.847.5378
|
gwen.gordon@bd.com
|
monique_dolecki@bd.com
|
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SOURCE BD (Becton, Dickinson and Company)