Extended genotyping: Enabling healthcare professionals to more precisely identify the risk of cervical disease

The clinical value
of extended genotyping

"Extended genotyping" refers to those high-risk HPV types beyond types 16 and 18 that may impact patients and lead to high cervical disease risk.1
Extended genotyping enables risk stratification1 and persistence monitoring2,3 to help prevent more cases of cervical cancer.
As the vaccinated population increases, the prevalence of high-risk HPV types beyond 16 and 18 may change.


THE BD ONCLARITY™ HPV ASSAY PROVIDES VISIBILITY INTO HIGH-RISK GENOTYPES
BEYOND HPV 16 AND 18

The BD Onclarity™ HPV Assay enables risk stratification

Risk of cancer in women with NILM cytology
3-year risk of cancer (future risk)

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

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HPV 16 and HPV 31 have the highest risk of ≥CIN31
The other 9-valent vaccine types, HPV 18, 33/58, 52 and 45 have intermediate risk of ≥CIN31
HPV 51, HPV 35/39/68 and HPV 56/59/66, while very prevalent, have a very low ≥CIN3 risk1
Adapted from Stoler MH et al. Gynecol Oncol. 2019,153(1):26-33.
Learn more Focus on patients most at risk

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

Adapted from Schiffman M et al. Int J Cancer. 2016;139(11):2606-2615.
Learn more Focus on patients most at risk

Individual identification of HPV 31 and HPV 45 matters

The value of HPV 31
The clinical importance of HPV 45

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

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HPV 31 poses the next highest risk for ≥CIN3 disease after HPV 16, and is higher than HPV 181,5
Assays that combine different genotypes into a single pool (12-other HR) artificially mask the true underlying risk of ≥CIN3 disease especially due to HPV 31*5
Absolute risk of ≥CIN3

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

Prevalence
Adapted from de Sanjose S et al. Lancet Oncol. 2010;11:1048-1056.
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





HPV 16, 18, 31, 33, 58
All ages OR = 0.4 (95% CI: 0.4, 0.5);
p < 0.001
Other 9 HPV
All ages OR = 1.2 (95% CI: 1.0, 1.3);
p = 0.009

The prevalence of vaccine-targeted genotypes (HPV 16 and 18) were significantly lower
in vaccinated women compared to unvaccinated women.*8

A lower prevalence was also observed with HPV 31 and HPV 33, 58 due to a probable vaccine
cross-protection.*8

The prevalence of the other 9 high-risk HPV genotypes (pooled results) were increased in vaccinated women.*8

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.

Learn more Track genotype-specific persistence
  • 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.
  1. Stoler et al. Gynecol Oncol. 2019;153(1):26-33.
  2. Radley D et al. Hum Vaccin Immunother. 2016;12(3):768-772.
  3. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1-7.
  4. Schiffman M et al. Int J Cancer. 2016;139(11):2606-2615.
  5. BD Data on file.
  6. de Sanjose S et al. Lancet Oncol. 2010;11:1048-1056.
  7. 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.
  8. Wright TC et al. Gynecol Oncol. 2019;153(2):259-265.