BD Onclarity™ HPV Assay
Enable precise care decisions by choosing a clinically-validated test with extended genotyping and self-collection* option
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Elevate the standard of cervical cancer screening
Guidelines support enhanced risk stratification with extended genotyping and the use of BD Onclarity™ HPV Assay with self-collection* option.1,†
BD Onclarity™ HPV Assay is the only clinically-validated test with both extended genotyping and self-collection* to help inform personalized treatment decisions.2
The most comprehensive results that individually detect more high-risk HPV genotypes
In the post-vaccination era the prevalence of high-risk genotypes may change, it is crucial to identify high-risk genotypes individually.
BD Onclarity™ HPV Assay delivers comprehensive results with extended genotyping:†,3-7
It’s time to redefine screening and make powerful progress towards eliminating cervical cancer
Test with the clinically-validated and ASCCP-recommended BD Onclarity™ HPV Assay.1
A paradigm-shifting, ASCCP-recommended screening
The American Society for Colposcopy and Cervical Pathology (ASCCP), Enduring Risk-Based Management Guidelines support extended genotyping and the use of BD Onclarity™ HPV Assay.1
Download the latest clinical recommendations to enhance patient management.1
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Precise patient management
Confidently manage your patients treatment of cervical cancer with accurate and comprehensive reporting of more individual high-risk HPV genotypes.†,3-7
Increase screening rates
Help patients facing barriers to screening by providing an approachable self-collection option performed in health care settings.*
Accuracy you can trust
- Count on accuracy that is comparable to samples collected in a traditional pelvic exam and with internal control to verify sample adequacy.2,8
- Targeting the E6/E7 region of the HPV viral genome rather than the L1 region, which can be deleted during HPV DNA integration.2
End-to-end solution
- BD Onclarity™ HPV Assay can be processed, from specimen to report, with end-to-end automation that optimizes lab’s time and resources.
- Dry sample transport streamlines clinical workflow and supports extended stability of up to 30 days.2
Our collection of literature on industries and on our offerings gives you information you can use to continue striving for excellence.
BD Onclarity™ HPV Assay Videos
Dr. Andrews talks about extended genotyping
Dr. Stoler, MD talks about self-collection* for HPV
Transforming Access: The role of HPV to self-collection*
BD Onclarity™ HPV Assay Webinars
Watch On-demand | Cervical cancer screening webinar
Watch On-demand | Automation and emerging methods webinar
Automation and Emerging Methods with New Guidelines for HPV self-collection and extended Genotyping
Watch On-demand | Cervical cancer screening advancements webinar
Making sense of it all: Advancements in cervical cancer screening using BDOnclarity™ HPV Assay with extended genotyping and self-collection in ahealthcare setting
The latest efforts in cervical cancer prevention: An interview with Leeya Pinder, MD
Dr. Leeya Pinder, gynecologic oncologist and global health clinician, shares insights with Medical Laboratory Observer from the National HPV Conference, highlighting innovative approaches to cervical cancer prevention.
First US national HPV conference highlights advances in cancer prevention
In an interview with Contemporary OB/GYN, Dr. Pinder discussed the importance of scaling up self-collection options and integrating them into existinghealthcare frameworks. This innovation could significantly improve screening access, especially for hard-to-reach populations.
Latest Guidelines and Best Practices on Cervical Cancer Screening
Cervical cancer is largely preventable, yet screening gaps persist. The ASCCP now recognizes the BD Onclarity™ HPV assay with extended genotyping for primary HPV screening. This assay helps clinicians reduce unnecessary follow-up testing by providing more precise risk stratification.
New guidelines also endorse self-collected vaginal swabs for HPV testing, widening access for those facing barriers to clinician-collected screening. A Harris Poll survey commissioned by BD found that 72% of US respondents delayed gynecologic visits due to fear, discomfort, or scheduling constraints; 81% preferred a self-collection option.
Dr. Jeff Andrews, VP of Medical Affairs, BD Life Sciences, discusses how these updates can narrow screening gaps in an interview with Patient Care’s Chris Mazzolini.
BD HPV Assay Added to ASCCP Guidelines for Cervical Cancer Screening
BD Onclarity™ HPV Assay is now part of ASCCP guidelines, enhancing precision in HPV screening and cervical cancer prevention. Dr. Jeff Andrews discusses the benefits of extended genotyping. Read the article in CLP.
* Self-collected vaginal specimens, obtained in a healthcare setting, can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical samples otherwise cannot be obtained.
† The BD Onclarity HPV Assay is the only FDA-approved HPV test which provides the capability for individually genotyping six high-risk types and three genotype groups.
- ASCCP. Management Guidelines and the Enduring Guidelines Process. Accessed February 2025.
- BD Onclarity™ HPV Assay US Package Insert [8089894]
- Bonde JH et al. J Low Genit Tract Dis. 2020;24(1):1–13.
- Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–7.
- Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–72.
- Bodily J and Laimins LA. Trends Microbiol. 2011;19(1):33–9.
- Stoler MH et al. Gynecol. Oncol. 2019; 153(1):26–33.
- Martinelli M et al. Performance of BD Onclarity HPV assay on FLOQSwabs vaginal self-samples. Microbiology spectrum. Published online February 7, 2024.