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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
Extended genotyping supports risk stratification and persistence monitoring to guide patient management1-5
Make more informed decisions with the extended genotyping information you need to assess each patient’s risk for confident follow-up decisions1-5
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
- 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
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- Stoler MH et al. Gynecol Oncol. 2019;153(1):26–33
- Bonde J et al. Int J Cancer. 2019; doi:10.1002/ijc.32291
- Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–264.e7.
- Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–772.
- Bottari F et al. J Low Genit Tract Dis. 2019;23(1):39–42.
- WHO RHR. Cervical cancer, human papillomavirus (HPV), and HPV vaccines—key points for policy-makers and health professionals. WHO; 2007.
- Oliver SE et al. J Infect Dis. 2017;216(5):594–603.
- Drolet M et al. Lancet Infect Dis. 2015;15(5):565–580.
- Garland SM et al. Clin Infect Dis. 2016;63(4):519–527.
- Schiffman M et al. Gynecol Oncol. 2015;138(3):573–578.
- Schiffman M et al. Int J Cancer. 2016;139(11):2606–2615.
- BD OnclarityTM HPV Assay US Package Insert (8089899)
- Tjalma WAA et al. Eur J Obstet Gynecol Reprod Biol. 2013;170(1):45–46.