Improve cervical cancer screening with identification of HPV 31

Only an HPV assay with extended genotyping can individually identify hr-HPV genotypes beyond HPV 16 and 18, including HPV 31, which poses a similar risk for cervical precancer as compared to HPV 18 and should be managed similarly.1-4

HPV 31 is the second highest-risk HPV genotype for CIN3+ disease1,2,5

Bayesian model for risk of ≥CIN3 by HPV genotype

Bayesian model for risk of CIN3 by HPV genotype

Stoler MH et al. Gynecol Oncol 2019;153(1):26–33.

In a US study from 2019, women 25 years and older with HPV 31 and normal cytology had an immediate risk for CIN2+ of 12.1%, similar to HPV 16, with a risk of 11.6%.1

Risk of CIN2+ by HPV type in women > 25 years with normal cytology1

1833 5852514535 39 6856 59 66HP V - 3116HP V+ 0%1%2%3%4%5%6%7%8%9%10%11%12%13%

Created from information provided in Stoler MH et al. Gynecol Oncol 2019;153(1):26–33.

In a US study from 2019, women 25 years and older with HPV 31 and normal cytology had an immediate risk for CIN3+ of 7.5%, similar to HPV 16, with a risk of 8.1%.1

Risk of CIN3+ by HPV type in women > 25 years with normal cytology

0%1%2%3%4%5%6%7%8%9%1833 585251 A SCCP’s 4% risk th r eshold f or r e f er r al t o c olpos c o p y 44535 39 6856 59 66HP V - 3116HP V+

Created from information provided in Stoler MH et al. Gynecol Oncol 2019;153(1):26–33.

What is CIN?
HPV assays that individually identify HPV 31 allow for:

Accurate risk-stratification

HPV 31 poses a similar risk for cervical precancer and cancer as compared to HPV 18 and should be managed similarly.1–8

Most HPV tests report multiple genotypes in a single result, which can both artificially mask the true risk of CIN3+ disease – especially due to HPV 31 – and lead to a 1-year follow-up recommendation instead of an immediate colposcopy referral.2,4 

Appropriate and timely clinical management

A systematic review of 16 studies shows that HPV 31 poses a similar or higher risk for CIN3+ disease as compared to HPV 18, above the ASCCP’s 4% immediate risk of CIN3+ threshold for referral to colposcopy.1–4

The only FDA-approved
assay that can identify HPV 31

ASCCP, American Society for Colposcopy and Cervical Pathology; CIN, cervical intraepithelial neoplasia; FDA, Food and Drug Administration; HC2, Hybrid Capture 2; HPV, human papillomavirus; hr, high risk

1. Stoler MH et al. Am J Clin Pathol. 2019;151(4):433–42.
2. Bonde JH et al. J Low Genit Tract Dis. 2020;24(1):1–13.
3. Monsonego J et al. Gynecol Oncol. 2015;137(1):47-54.
4. Perkins RB et al. J Low Genit Tract Dis. 2020;24:102–31.
5. Bonde J et al. Int J Cancer. 2019;145:1033–41.
6. Schiffman M et al. Gynecol Oncol. 2015;138(3):573–8.
7. Schiffman M et al. Int J Cancer. 2016:139:2606–15.
8. Schiffman M et al. J Clin Microbiol. 2015;53(1):52–9.