BD Onclarity™ HPV Assay

Extend the power of HPV testing

Overview
Products & Accessories
EIFU & Resources

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

FDA and Health Canada 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 management^1-5
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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Support risk stratification

Extended genotyping supports risk stratification and persistence monitoring to guide patient management^1-5

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

Make more informed decisions with the extended genotyping information you need to assess each patient’s risk for confident follow-up decisions^1-5

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 decisions^1-5

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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.

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