Assays

Extend the power of HPV testing

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
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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 provides extended genotyping, offering the flexibility you need to adapt to changing clinical landscape and screening guidelines, including self-collection

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 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
  • New! The BD Onclarity™ HPV Assay supports vaginal specimens self- collected at either the clinic or in the home-setting12

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 Onclarity™ HPV Assay EU Package Insert (8089899). 13. Tjalma WAA et al. Eur J Obstet Gynecol Reprod Biol. 2013;170(1):45–46.