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BD Onclarity™ HPV Assay

Extend the power of HPV testing

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Overview

The BD Onclarity™ HPV Assay is FDA-approved for extended genotyping, offering the flexibility you need to adapt to changing screening guidelines and evolving patient management guidance.

FDA approved for all three screening paradigms:

In the post-vaccination era the prevalence of high-risk genotypes may change making it crucial to identify high-risk genotypes individually.

  • Extended genotyping supports risk stratification and persistence monitoring to guide patient management1-5
  • Genotypes 16 and 18 account for 70% of invasive cancer worldwide, but their prevalence is declining as vaccination rates increase.6-9
  • Genotypes 31,33,58 have a CIN3+ risk similar to genotype 18, but 51,35,39,68,56,59,66 have a much lower risk.10-11
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Features and Benefits
Support risk stratification
Support risk stratification

Extended genotyping supports risk stratification and persistence monitoring to guide patient management1-5

Adapt to evolving screening guidelines
Adapt to evolving screening guidelines
The BD Onclarity™ HPV Assay offers the flexibility you need to adapt to changing screening guidelines and evolving patient management guidance.
Enhance patient management
Enhance patient management

Make more informed decisions with the extended genotyping information you need to assess each patient’s risk for confident follow-up decisions1-5

Genotype reporting
Genotype reporting

The BD Onclarity™ HPV assay reports individual results for 6 of the 14 high-risk genotypes and grouped results for the remaining 8 high-risk genotypes.12

Providing you with advanced accurate, timely detection and actionable HPV genotyping so you can make more informed decisions.
  • The BD Onclarity™ HPV assay is designed to minimize the risk of false-negative results by:
    • Including an internal cellular control, ensuring cellular material is present
    • Targeting the E6/E7 region of the HPV viral genome rather than the L1 region, which can be deleted during HPV DNA integration13
  • The BD Onclarity™ HPV assay is designed to minimize the rise of false-positive results by lacking cross-reactivity with low-risk HPV types12
  • Make more informed decisions with the extended genotyping information you need to assess each patient’s risk for confident follow-up decisions1-5

Products & Accessories

References
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Resources
References
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Reference
  1. Stoler MH et al. Gynecol Oncol. 2019;153(1):26–33
  2. Bonde J et al. Int J Cancer. 2019; doi:10.1002/ijc.32291
  3. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–264.e7.
  4. Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–772.
  5. Bottari F et al. J Low Genit Tract Dis. 2019;23(1):39–42.
  6. WHO RHR. Cervical cancer, human papillomavirus (HPV), and HPV vaccines—key points for policy-makers and health professionals. WHO; 2007.
  7. Oliver SE et al. J Infect Dis. 2017;216(5):594–603.
  8. Drolet M et al. Lancet Infect Dis. 2015;15(5):565–580.
  9. Garland SM et al. Clin Infect Dis. 2016;63(4):519–527.
  10. Schiffman M et al. Gynecol Oncol. 2015;138(3):573–578.
  11. Schiffman M et al. Int J Cancer. 2016;139(11):2606–2615.
  12. BD OnclarityTM HPV Assay US Package Insert (8089899)
  13. Tjalma WAA et al. Eur J Obstet Gynecol Reprod Biol. 2013;170(1):45–46.
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