FRANKLIN LAKES, N.J.,
Feb. 13, 2018 /PRNewswire/
-- BD (Becton, Dickinson and Company) (NYSE: BDX), a
leading global medical technology company, today announced that it
has received pre-market approval from the U.S. Food and Drug
Administration (FDA) for the BD Onclarity™ HPV assay. The test
detects 14 types of high-risk human papillomavirus (HPV) from
specimens collected for cervical cancer screening ("Pap test") in
the BD SurePath™ liquid based cytology vial. The
BD Onclarity™ HPV assay also identifies HPV genotypes
16, 18, and 45, which are associated with the majority of cervical
cancers worldwide, and are disproportionally responsible for up to
94 percent of glandular cervical cancer cases.1,2
In evaluating the test, the FDA reviewed data collected
during a multi-year, prospective, multi-center clinical trial
conducted in the US that included more than 33,500 vaccinated and
non- vaccinated women.
The BD Onclarity™ HPV assay may be used in accordance
with clinical guidelines3,4 for cervical cancer
screening and management to identify the presence of high-risk HPV
types. The test is clinically validated for use as a primary
screening test, for triaging patients with abnormal Pap test
results and to be used in combination with a Pap test. The BD
Onclarity™ HPV assay provides information that together with
the physician's assessment and professional guidelines, may be used
to inform clinical decision-making.
BD intends to seek approval in future submissions for reporting
of HPV types beyond 16, 18 and 45 consistent with the extended
genotyping capabilities of the assay's design and aligned with
evolving cervical cancer screening guidelines.
"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 patients,"
said Dave Hickey, president, BD
Diagnostics Systems. "The addition of the BD Onclarity™ HPV
assay to BD's women's health and cancer portfolio will enable BD to
continue to enhance the standard of patient care, representing the
next milestone in cervical cancer screening."
Dr. Thomas C. Wright, Jr.,
professor emeritus of pathology and cell biology at Columbia University noted that "The approval of the
BD Onclarity™ HPV assay provides clinicians and laboratories
an FDA-approved option for HPV primary screening with the BD
SurePath™ liquid based cytology vial. The BD
Onclarity™ HPV assay also aligns with clinical screening
guidelines from the American Cancer Society, the American Society
for Colposcopy and Cervical Pathology and the American Society for
Clinical Pathology."
The BD Onclarity™ HPV assay is performed on the BD Viper™
LT system, a bench top molecular platform which automates sample
processing and is also FDA-cleared for chlamydia and/or gonorrhea
infection (CT/GC) testing. The BD Onclarity™ HPV assay
achieved the European CE-IVD mark in 2014, received regulatory
approval in Canada and
Japan in 2017, and is currently
for sale in these and other markets.
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 improve patient
outcomes, improve the safety and efficiency of clinicians' care
delivery process, enable laboratory scientists to better diagnose
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. In 2017, BD welcomed C. R.
Bard and its products into the BD family. For more information on
BD, please visit bd.com.
References
- 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.
- 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.
- Saslow, D et al. (2012) American Cancer Society, American
Society for Colposcopy and Cervical Pathology, and American Society
for Clinical Pathology Screening Guidelines for the Prevention and
Early Detection of Cervical Cancer. J Low Genit Tract Dis. July;
16(3): 175–204. doi:10.1097/LGT.0b013e31824ca9d5.
- Huh, WH et al. (2015) Use of primary high-risk human
papillomavirus testing for cervical cancer screening: Interim
clinical guidance. Gynecologic Oncology 136: 178–182.
Contacts:
|
|
Gwen
Gordon
|
Monique N.
Dolecki
|
BD Public
Relations
|
BD Investor
Relations
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858.812.3724
|
201.847.5378
|
gwen.gordon@bd.com
|
monique_dolecki@bd.com
|
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SOURCE BD (Becton, Dickinson and Company)