FRANKLIN LAKES, N.J.,
July 22, 2020 /PRNewswire/
-- BD (Becton, Dickinson and Company) (NYSE: BDX), a
leading global medical technology company, today announced that it
received approval for a pre-market approval (PMA) supplement from
the U.S. Food and Drug Administration (FDA) for an expanded version
of its BD Onclarity™ HPV Assay. The PMA supplement includes 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
genotypes making the BD Onclarity™ HPV Assay the only FDA-approved
assay to individually identify and report these genotype
results.
The value of extended genotyping for cervical cancer screening
and triage has been reported from large clinical studies since
2015.1-8 Additionally, the need for expanded HPV
genotyping for cervical screening has been recognized since
2016.9 In many cases, the reporting of HPV genotypes
with the screening test result could improve risk stratification
and support risk-based patient management. The April 2020 publication of the ASCCP risk-based
management consensus guidelines anticipated that extended
genotyping would be introduced soon.10
"BD Onclarity™ extended genotyping is data-driven precision
medicine at its best, helping us effectively and efficiently manage
our patients," said Mark H. Stoler,
MD Professor Emeritus of Pathology, University
of Virginia Health System. "Contemporary management of women
with abnormal cervical cancer screening results demands an
assessment of their risk of pre-cancer. An abundance of recent
science clearly shows that knowing the HPV genotype of the patient
provides excellent differential stratification of those
risks."1,4-8,11-13
"It is well known that different HPV genotypes carry different
risk of cervical cancer, and without the specific knowledge of the
HPV genotype in a screening sample many women will be over-treated
needlessly," said Jesper Bonde, PhD,
Senior Researcher and Molecular Pathology Laboratory Manager,
Hvidovre Hospital, Denmark.12 "Screening
strategies that employ HPV tests with simultaneous genotyping offer
a simple way to improve cervical cancer screening to the benefit of
the woman and health care providers by allowing risk stratification
already on the screening sample."
The reporting of HPV genotypes with the screening tests and
surveillance tests will facilitate same-genotype persistence
tracking and risk-based management. A recent systematic review by
Bottari et al concluded that, "evaluation of the HPV genotype
persistence may represent a valid option to monitor patients
treated for CIN 2+ lesions, because relapses were detected only in
patients with persistence of the same genotype detected at
baseline."11,13-15
"With this FDA approval, BD can now offer laboratories,
clinicians and patients access to critical information in screening
for cervical cancer in the United
States and other countries recognizing the PMA supplement or
CE mark," said Dave Hickey,
president, Integrated Diagnostic Solutions at BD. "Our goal is to
continue the global fight towards eliminating diseases and
associated deaths due to cervical cancer with our comprehensive
diagnostic solutions."
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 Visit bd.com to learn more.
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
- Wright, T. C., Jr. et al. Detection of Cervical
Neoplasia by Human Papillomavirus Testing in an Atypical Squamous
Cells-Undetermined Significance Population: Results of the Becton
Dickinson Onclarity Trial. Am J Clin Pathol 151,
53-62, doi:10.1093/ajcp/aqy084 (2019).
- Schiffman, M. et al. A cohort study of cervical
screening using partial HPV typing and cytology triage.
International journal of cancer 139, 2606-2615,
doi:10.1002/ijc.30375 (2016).
- Schiffman, M. et al. A study of HPV typing for the
management of HPV-positive ASC-US cervical cytologic results.
Gynecol Oncol 138, 573-578,
doi:10.1016/j.ygyno.2015.06.040 (2015).
- Stoler, M. H. et al. HPV Testing With 16, 18, and 45
Genotyping Stratifies Cancer Risk for Women With Normal Cytology.
American journal of clinical pathology 151, 433-442,
doi:10.1093/ajcp/aqy169 (2019).
- Stoler, M. H. et al. The Onclarity Human Papillomavirus
Trial: Design, methods, and baseline results. Gynecol Oncol
149, 498-505, doi:10.1016/j.ygyno.2018.04.007 (2018).
- Stoler, M. H. et al. Stratified risk of high-grade
cervical disease using onclarity HPV extended genotyping in women,
>/=25years of age, with NILM cytology. Gynecol Oncol
153, 26-33, doi:10.1016/j.ygyno.2018.12.024 (2019).
- Wright, T. C., Jr. et al. HPV infections and cytologic
abnormalities in vaccinated women 21-34years of age: Results from
the baseline phase of the Onclarity trial. Gynecol Oncol
153, 259-265, doi:10.1016/j.ygyno.2019.02.016 (2019).
- Wright, T. C., Jr. et al. Risk detection for high-grade
cervical disease using Onclarity HPV extended genotyping in women,
>/=21years of age, with ASC-US or LSIL cytology. Gynecol
Oncol 154, 360-367, doi:10.1016/j.ygyno.2019.05.012
(2019).
- Cuzick, J. & Wheeler, C. Need for expanded HPV genotyping
for cervical screening. Papillomavirus Res 2,
112-115, doi:10.1016/j.pvr.2016.05.004 (2016).
- Schiffman, M., Wentzensen, N., Perkins, R. B. & Guido, R.
S. An Introduction to the 2019 ASCCP Risk-Based Management
Consensus Guidelines. Journal of Lower Genital Tract Disease
24, 87-89, doi:10.1097/lgt.0000000000000531 (2020).
- Bottari, F. et al. Onclarity Human Papillomavirus
Extended Genotyping in the Management of Cervical Intraepithelial
Neoplasia 2+ Lesions. J Low Genit Tract Dis 23,
39-42, doi:10.1097/LGT.0000000000000441 (2019).
- Bonde, J. H., Sandri, M. T., Gary, D. S. & Andrews, J. C.
Clinical Utility of Human Papillomavirus Genotyping in Cervical
Cancer Screening: A Systematic Review. J Low Genit Tract Dis
24, 1-13, doi:10.1097/LGT.0000000000000494 (2020).
- Bottari, F. et al. Human Papillomavirus Genotyping
Compared With a Qualitative High-Risk Human Papillomavirus Test
After Treatment of High-Grade Cervical Intraepithelial Neoplasia: A
Systematic Review. Obstet Gynecol 134, 452-462,
doi:10.1097/AOG.0000000000003409 (2019).
- Bottari, F. & Iacobone, A. D. Profile of the BD HPV
OnclarityTM assay. Expert review of molecular diagnostics
19, 565-570, doi:10.1080/14737159.2019.1622415 (2019).
- Einstein, M. H. Precision Screening for Posttreatment
Surveillance. Obstetrics & Gynecology 134, 1-2
(2019).
Contacts:
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Gwen
Gordon
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Monique N.
Dolecki
|
BD Public
Relations
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BD Investor
Relations
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858.617.2897
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201.847.5378
|
gwen.gordon@bd.com
|
monique_dolecki@bd.com
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SOURCE BD (Becton, Dickinson and Company)