BD receives FDA Approval for HPV Test with Extended Genotyping Capabilities
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
"BD Onclarity™ extended genotyping is data-driven precision medicine at its best, helping us effectively and efficiently manage our patients," said
"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
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
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
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.
- 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
BectonDickinson 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. Needfor 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 Disease24, 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 Dis23, 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 Dis24, 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).
BD Public Relations
BD Investor Relations
View original content to download multimedia:http://www.prnewswire.com/news-releases/bd-receives-fda-approval-for-hpv-test-with-extended-genotyping-capabilities-301097526.html
SOURCE BD (