Extend the power
Assays

Extend the power of HPV testing

The BD OnclarityTM HPV Assay provides extended high-risk HPV genotyping results beyond 16 and 18, to support risk stratification and enhanced patient management

Support risk
stratification
Adapt to evolving
screening guidelines
Enhance patient
management

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 increase6-9
  • Genotypes 31/33/58 have a CIN3+ risk similar to genotype 18, but 51/35/39/68/56/59/66 have a much lower risk10,11
  • The BD OnclarityTM HPV assay reports individual results for 6 of the 14 high-risk genotypes and grouped results for the remaining 8 high-risk genotypes12

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

The BD OnclarityTM HPV assay is CE-IVD marked according to 98/79/EC directive for extended genotyping, offering the flexibility you need to adapt to changing clinical landscape and screening guidelines

HPV primary screening
HPV primary screening
HPV primary screening
Co-testing
HPV primary screening
Cytology primary + ASCUS reflex

Providing you with advanced accuracy, timely detection and actionable HPV genotyping so you can make more informed decisions

  • The BD OnclarityTM HPV assay is designed to minimize the risk of false-negative results by:
    • Including an internal cellular control
    • 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 OnclarityTM HPV assay is designed to minimize the risk of false-positive results by lacking cross-reactivity with low-risk HPV types12
  • The BD OnclarityTM HPV assay reports individual results for 6 of the 14 high-risk genotypes and grouped results for the remaining 8 high-risk genotypes12
  • Make more informed decisions with the extended genotyping information you need to assess each patient’s risk for confident follow-up decisions 7-11

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. World Health Organization, Department of Reproductive Health and Research. Cervical cancer, human papillomavirus (HPV), and HPV vaccines—key points for policy-makers and health professionals. 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 EU Package Insert (8089899). 13. Tjalma WAA et al. Eur J Obstet Gynecol Reprod Biol. 2013;170(1):45–46.