How can individually identifying more HPV types add value to your clinical practice and benefit your patients?

Review the patient profiles below to find out.

Tiana
Normal cytology
HPV 16-
HPV 18-
HPV 31+

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

HPV 31 poses a higher risk of precancer as compared to HPV 18.1 HPV tests that group HPV 31 with other HPV types in one pooled result may underestimate a woman’s risk for cervical precancer and cancer due to HPV 31.1,2

By using a test that can individually identify HPV 31, you offer your patients a more precise cervical cancer risk assessment compared to an HPV test with grouped results.3

Grace
Normal cytology
HPV 52+
ASC-US cytology
HPV 52+

Meet Grace*, who has a persistent infection with the same HPV type

Persistent infection with the same high-risk HPV type causes the cells of the cervix to change and is the number one risk factor for cervical precancer and cancer, regardless of the type.3-6

A test that individually identifies more high-risk HPV types expands your ability to determine if an HPV-positive result is due to a type-specific persistent infection, so you can focus on your patients most at risk for progression.3,4

Maya
Normal cytology
HPV 52+
Normal cytology
HPV 52-
HPV 51+

Meet Maya*, who cleared one HPV type and then tested positive for another

Testing positive for a different high-risk HPV type at two consecutive tests resets the risk for cervical precancer or cancer to that of having a new infection and is lower risk compared to having the same type.5

A test capable of individually identifying more high-risk HPV types expands your ability to determine if an HPV positive result at follow-up is due to a different HPV type.3

The 2019 ASCCP Risk-based Management Consensus Guidelines for the management of cervical cancer screening abnormalities recommend 1 of 6 clinical actions, according to the risk of cervical precancer and cancer (CIN3+ risk).7

View ASCCP's management algorithm

But how precise is the HPV test that you are using?

To make more informed decisions you need to be empowered with more information.

By using a test capable of individually identifying more high-risk HPV types you can more precisely determine a woman’s risk of cervical precancer and cancer compared to a test with a large, pooled "HPV Other" result – and ultimately offer your patients like Tianna, Grace and Maya a more informed, personalized management strategy. 1,3-5

BD Onclarity™ HPV Assay is the only FDA-approved HPV assay to test for an extended set of genotypes individually and adds value to your practice by:8-13

  • Individually identifying the top 3 HPV types that contribute the most to cervical precancer and cancer – HPV 16, 31, and 18.8,14
  • Tracking a persistent infection with the same high-risk HPV type – the number one risk factor for cervical precancer and cancer – for HPV 16, 18, 31, 45, 51 and 52.4,6,8
  • Identifying when one HPV type is replaced by another between tests versus a persistent infection with the same HPV type.4,8
  • Detecting lower risk types in strategic grouped results.8

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*Names and/or medical information presented on this page do not represent real people or clinical information.

ASCCP, American Society for Colposcopy and Cervical Pathology; CIN3+, cervical intraepithelial neoplasia grade 3, adenocarcinoma in situ, or cancer; FDA, Food and Drug Administration; HPV, human papillomavirus.

1. Stoler MH et al. Gynecol Oncol. 2019,153(1):26–33.
2. Egemen D et al. J Low Genit Tract Dis. 2020;24(2):132–43.
3. Bonde J et al. J Low Genit Tract Dis. 2020;24(1):1–13.
4. Bonde J et al. J Low Genit Tract Dis. 2021;25(1):27–37.
5. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–7.
6. Bodily J, Laimins LA. Trends Microbiol. 2011;19(1):33–9.
7. Perkins RB et al. J Low Genit Tract Dis. 2020;24(2):102–31.
8. BD Onclarity™ HPV Assay US Package Insert [8089894].
9. digene® HC2 High-Risk HPV DNA Test Package Insert.
10. Aptima™ HPV Assay US Package Insert.
11. Cervista™ HPV HR US Package Insert.
12. cobas® HPV for 4800 System US Package Insert.
13. cobas® HPV for 6800/8800 System US Package Insert.
14. ICO/IARC Information Centre on HPV and Cancer (HPV Information Centre). Human Papillomavirus and Related Diseases in United States of America. Summary Report 10 March 2023. Accessed August 11, 2023.