What if identifying HPV 31 could make the difference?

Not all HPV tests can identify women who test positive for HPV 31.

The BD Onclarity™ HPV Assay is the only FDA-approved HPV test that identifies women who are
HPV 31-positive, which means that they are at a high risk of precancer.^1-3

Why does it matter?

HPV 16, 52, 51, 39, 59, and 31
are the most common genotypes in US women with normal cytology (in order of prevalence)⁴

HPV 16, 31, 52, 51, 18 and 58
are the genotypes most frequently associated with high-grade cervical lesions in the US
(in order of prevalence)⁴

This means that the proportion of HPV 31 is increased in women with precancerous
lesions compared to women with normal cytology, and that HPV 31
is more frequent than HPV 18 in precancer.⁴

If you were able to identify women who test positive for HPV 31, you could adapt your clinical
decisions in light of the risk associated with this genotype.^1,5

Meet Tianna, a 35-year-old who tested positive for HPV 31

How does it impact her to know if she is HPV 31-positive?

Every woman deserves to know if she is positive for HPV 31 because it could mean a different
management for her.^1,5 Following the American Society for Colposcopy and Cervical Pathology (ASCCP) principle of “similar management for similar risk”, women with an immediate risk for CIN3+ disease above 4% should be referred to colposcopy.⁵

In the BD Onclarity™ FDA trial, women 25 years and older with HPV 31 and normal
cytology had an immediate risk for CIN3+ that exceeded the colposcopy referral threshold.^1-5

This trial showed that being HPV 31-positive poses a higher risk for precancer as compared to HPV 18.¹

The BD Onclarity™ HPV Assay is the only FDA-approved HPV test that can individually identify high-risk HPV genotypes beyond HPV 16 and 18, including HPV 31.^2,3
 

You screen for HPV 16 and 18 – so why not 31?

ASCCP, American Society for Colposcopy and Cervical Pathology; CIN, cervical intraepithelial neoplasia; FDA, Food and Drug Administration; HPV, human papillomavirus.

1. Stoler MH et al. Gynecol. Oncol. 2019; 153(1):26–33.
2. BD Onclarity^TM HPV Assay US Package Insert [8089894].
3. Salazar KL et al. J Am Soc Cytopathol. 2019;8(5):284–92.
4. ICO/IARC Information Centre on HPV and Cancer (HPV Information Centre). Human Papillomavirus and Related Diseases in United States of America. Summary Report 22 October 2021. Accessed July 1, 2022.
5. Perkins RB et al. J Low Genit Tract Dis. 2020;24:102–31.