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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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Overview

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

More Robust Results

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

Guideline-recommended

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

Features and Benefits
Precise patient management

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

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

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

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


Contact Us 

EIFUs
Resources

BD Onclarity™ HPV Assay Videos

Articles

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.

Reference

* 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.

  1. ASCCP. Management Guidelines and the Enduring Guidelines Process. Accessed February 2025.
  2. BD Onclarity™ HPV Assay US Package Insert [8089894]
  3. Bonde JH et al. J Low Genit Tract Dis. 2020;24(1):1–13.
  4. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–7.
  5. Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–72.
  6. Bodily J and Laimins LA. Trends Microbiol. 2011;19(1):33–9.
  7. Stoler MH et al. Gynecol. Oncol. 2019; 153(1):26–33.
  8. Martinelli M et al. Performance of BD Onclarity HPV assay on FLOQSwabs vaginal self-samples. Microbiology spectrum. Published online February 7, 2024.  
BD Onclarity™ HPV Assay BD BD Onclarity™ HPV Assay

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

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Enable precise care decisions by choosing a 
clinically-validated test with extended genotyping and self-collection* option