Meet Grace*

  • 41 years old
  • No medical conditions
  • Is a busy entrepreneur, but always on top of her healthcare appointments
  • Has cervical cancer screening done about every 5 years

Last year, Grace found out she tested positive for HPV 52 and her OB/GYN strongly recommended follow-up testing in one year for surveillance to see if the infection would clear or if it would persist.

Cervical cancer screening history

Past test results:

  • Normal cytology
  • Positive for HPV 52
  • Negative for all other high-risk HPV types

Current results:

  • ASC-US cytology
  • Positive for HPV 52
  • Negative for all other high-risk HPV types

Grace’s new test results showed atypical squamous cells of undetermined significance (ASC-US) and a persistent infection with HPV 52.


“When my OB/GYN told me that I was still positive for HPV 52, I was shocked. A persistent HPV infection can be serious and lead to cervical cancer. I’m so thankful that my doctor used this test and followed-up.”


Normal cytology
HPV 52+


ASC-US cytology
HPV 52+

A persistent infection with the same high-risk HPV type causes the cells of the cervix to change and is the single greatest risk factor for malignant progression.1-4

Take a deeper look at the clinical data on HPV persistence

Cummulative proportion of CIN2+ among women with genotype-specific HPV persistence

Clinical data graph

Adapted from Elfgren et al. Am J Obstet Gynecol. 2017;216:264e1-7.
2.527 women aged 32-38 years with follow up of 195 women attending colposcopy who were cytologically normal but persistently HPV positive for at least 1 year

Take a look at Grace's lab report
Let’s first determine Grace’s immediate risk of precancer and cancer (CIN3+ risk)
In women with a repeated HPV-positive test and ASC-US cytology

the immediate risk of CIN3+ is

Based on the estimated immediate CIN3+ risk the ASCCP guidelines recommend a colposcopy.6

Unfortunately, using this data could underestimate Grace’s specific CIN3+ risk.

Indeed, the above CIN3+ risk is an estimate determined in women who have a current HPV-positive/ASC-US result obtained in follow-up of an HPV-positive/NILM cytology co-test, without any mention of the HPV type. In other words, it was not known if they had the same HPV type or a different HPV type between the two consecutive HPV tests.5

And this makes a big difference.

Why? Because a persistent infection with the same high-risk HPV type causes the cells of the cervix to change and is considered the most important determinant of cervical cancer risk in women who test HPV positive – regardless of the HPV type.1-4 On the other hand, an infection with a different HPV type compared to the previous screening resets the risk to that of a newly acquired infection.3

Grace has had a persistent infection with HPV 52 for over a year, which means that her CIN3+ risk could be even higher.2,3

Does your test identify same-type HPV persistence?

Most HPV tests have partial genotyping, which means that they cannot identify which HPV genotype is causing the infection beyond HPV 16 and 18 because the other genotypes are reported in a single pooled result.1,7

The BD Onclarity™ HPV Assay has extended genotyping, which means that it can individually identify 6 HPV types with the highest risk for disease. From one test to the next, it is possible to know if there is a continued infection with the same high-risk HPV type, if the HPV infection was cleared, or if there was a clearance with subsequent new HPV type detection.1,2

By using an assay that calls out more HPV types individually, you can monitor a continued infection with the same high-risk HPV type and appropriately manage your patients most at risk for developing cervical disease like Grace.

I want to individually identify more high-risk HPV types

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.

Why is type-specific persistence not accounted for in the current ASCCP Risk-Based Management Guidelines?

In the past, HPV assays that utilize partial HPV genotyping only identified HPV 16 and HPV 18 individually and grouped the other 12 high-risk HPV types in a large, pooled "HPV Other" result – identifying them together in a single result and not distinguishing between them, making it impossible to differentiate a type-specific persistent infection from an infection clearance and subsequent new HPV type detection.1,7

The 2019 ASCCP Risk-based Management Guidelines were developed based on data collected between 2003 and 2017, when extended genotyping had not yet received FDA approval and the available assays only detected HPV 16, HPV 18 and/or HPV 45 individually.6

The ASCCP Management Guidelines are built in such a way that new technologies can be incorporated without an entire revision of the guidelines. This means that extended genotyping, which is now commercially available, could be incorporated in the future.6

The BD Onclarity™ HPV Assay is the only FDA-approved HPV test that can track a persistent HPV infection beyond just HPV 16 and 18, which is the most important determinant of cervical cancer risk in women who test HPV-positive.1-4,8-14

*Names and/or medical information presented on this page do not represent real people or clinical information.
Based on data from women ≥ 25 years with HPV-positive ASC-US results in follow-up of HPV-negative NILM results.4

ASC-US: atypical squamous cells of undetermined significance; ASCCP, American Society for Colposcopy and Cervical Pathology; CIN2+, cervical intraepithelial neoplasia grade 2; CIN3+, cervical intraepithelial neoplasia grade 3, adenocarcinoma in situ, or cancer; FDA, Food and Drug Administration; HPV, human papillomavirus; NILM: negative for intraepithelial lesion or malignancy.

1. Bonde J et al. J Low Genit Tract Dis. 2020;24(1):1–13.
2. Bonde J et al. J Low Genit Tract Dis. 2021;25(1):27–37.
3. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–7.
4. Bodily J, Laimins LA. Trends Microbiol. 2011;19(1):33–9.
5. Egemen D et al. J Low Genit Tract Dis. 2020;24(2):132–43.
6. Perkins RB et al. J Low Genit Tract Dis. 2020;24(2):102–31.
7. Salazar KL et al. J Am Soc Cytopathol. 2019;8(5):284–92.
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. Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–72.