Shape the future of cervical cancer screening.

IDENTIFY HPV 31

Learn more

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

This form is only intended for use by healthcare professionals seeking additional information about BD products and solutions. Patients seeking health and treatment information should contact their healthcare professional and can find additional resources from ACOG and the American Cancer Society.

Do not submit protected health information (PHI) or patient information (PII) through this form. If you do submit PHI or PII, your question may not be answered, as the information will be deleted to protect your privacy.

 

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.