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BD OnclaRITY™ HPV Assay is the only FDA-approved HPV test that individually identifies HPV 31.

HPV 31 poses a higher risk for cervical precancer as compared to HPV 18.

The BD Onclarity™ HPV Assay with extended genotyping allows for a more precise, accurate way to measure a woman’s risk for developing cervical precancer and cancer compared to an assay with partial genotyping.1,2,3

HPV 31 identification matters. Extended genotyping is critical.

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.

Following the ASCCP principle of “similar management for similar risk”, women with an immediate risk for CIN3+ disease above 4% should be referred to colposcopy. Women 25 years and older with HPV 31 and normal cytology had an immediate risk for CIN3+ of 7.5%, similarly to HPV 16, with a risk of 8.1%.2

Learn more about extended genotyping with the BD Onclarity™ HPV Assay

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HPV assays that individually
identify HPV 31 allow for

Accurate risk-stratification

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.5,6

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.4,5

ASCCP, American Society for Colposcopy and Cervical Pathology; CIN, Cervical Intraepithelial Neoplasia; HPV, human papillomavirus

1. Monsonego J et al. Gynecol Oncol. 2015;137(1):47-54.
2. Stoler MH et al. Am J Clin Pathol. 2019;151(4):433-42.
3. Salazar K et al. J Am Soc Cytopath. 2019;8:284-92.
4. Perkins RB et al. J Low Genit Tract Dis. 2020;24:102-31.
5. Bonde JH et al. J Low Genit Tract Dis. 2020;24(1):1-13.
6.  Drolet M et al. Lancet. 2019;394(10197):497-509.