The clinical value
of extended genotyping
The BD Onclarity™ HPV Assay enables risk stratification
HPV genotypic information stratifies the baseline risk of precancer/cancer in women
The 14 hrHPV genotypes naturally fall into 3 distinct risk groups1
Baseline risk of ≥CIN3 by HPV type in women ≥25 years with NILM cytology1
Individual HPV genotyping enables healthcare professionals to more precisely identify the risk for developing cervical cancer in the future
3-year cumulative risk of ≥CIN3 by HPV type, all cytology4
Learn more Focus on patients most at risk
Individual identification of HPV 31 and HPV 45 matters
By individually identifying HPV 31, BD Onclarity™ HPV Assay provides highly valuable information to determine the risk for ≥CIN3 disease5
Absolute risk of ≥CIN3 according to HPV type (baseline, any cytology, ≥25 years)5
Data from BD Onclarity™ US PMA Baseline Study (33,858 enrolled subjects; > 6,000 with colposcopic biopsies).
*The pooled 12-other risk is an average of its constituent types.
With the BD Onclarity™ HPV Assay, the identification of HPV 45 along with HPV 16 and 18 provides clinically relevant information to determine the risk of adenocarcinoma6,7
Prevalence of HPV types in adenocarcinoma6
Learn more The challenge of adenocarcinomas
Extended genotyping helps monitor HPV genotype shifts
As the vaccinated population increases, the BD Onclarity™ HVP Assay may help monitor the changes in prevalence of high-risk HPV types.
Prevalence of high-risk HPV genotypes by age groups and vaccine status*8
All ages OR = 0.4 (95% CI: 0.4, 0.5);
p < 0.001
All ages OR = 1.2 (95% CI: 1.0, 1.3);
p = 0.009
Adapted from Wright TC et al. Gynecol Oncol. 2019;153(2):259-265.
*The majority of known vaccinated women (89.2%) received the 4vHPV vaccine, which targets HPV genotypes 6, 11, 16, and 18.
- ASC-US, atypical squamous cells of undetermined significance;
- ≥ASC-US, atypical squamous cells of undetermined significance or greater;
- CI, confidence interval;
- CIN, cervical intraepithelial neoplasia;
- CIN1, cervical intraepithelial neoplasia grade 1;
- CIN2, cervical intraepithelial neoplasia grade 2;
- CIN3, cervical intraepithelial neoplasia grade 3;
- HPV, human papillomavirus;
- hrHPV, high-risk human papillomavirus;
- HSIL, high grade squamous intraepithelial lesion;
- LSIL, low grade squamous intraepithelial lesion;
- NILM, negative for intraepithelial lesions or malignancies;
- OR, odds ratio;
- SCC, squamous cell carcinoma;
- UNSAT, unsatisfactory cytology result;
- UNVACC, unvaccinated;
- VACC, vaccinated;
- VBA, verification bias adjustment.
- Stoler et al. Gynecol Oncol. 2019;153(1):26-33.
- Radley D et al. Hum Vaccin Immunother. 2016;12(3):768-772.
- Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1-7.
- Schiffman M et al. Int J Cancer. 2016;139(11):2606-2615.
- BD Data on file.
- de Sanjose S et al. Lancet Oncol. 2010;11:1048-1056.
- Bruni L et al. ICO/IARC Information Centre on HPV and Cancer (HPV Information Centre). Human Papillomavirus and Related Diseases in the World. Summary Report 22 January 2019.
- Wright TC et al. Gynecol Oncol. 2019;153(2):259-265.