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

Meet Maya*

45 years old
No medical conditions
Trusts her OB/GYN and is aware of the benefits of regular cervical cancer screening
Has cervical cancer screening test every 5 years

Maya had a positive test result with HPV 52 one year ago and has come back for a follow-up HPV test as instructed by her OB/GYN.

Cervical cancer screening history

Past test results:

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

Current results:

Normal cytology
Positive for HPV 51
Negative for HPV 52 and all other high-risk HPV types

1-year after her initial positive HPV test, she cleared the infection with HPV 52 and tested positive for a different type, HPV 51.

“At first, having a positive result with a different HPV type didn’t make sense to me. Then, my OB/GYN explained that HPV can sometimes be undetectable for years before showing on a test. I’m now reassured because it actually means my risk is lower than if I had the same HPV type as last year.”

2022

Normal cytology

HPV 52+

2023

Normal cytology

HPV 52-

HPV 51+

Take a look at Maya’s lab report

1

Let’s look at Maya’s immediate risk for cervical precancer and cancer (CIN3+ risk)

With an HPV test that can individually identify more HPV types

Maya’s OB/GYN was able to see that the HPV 52 infection that she had last year was cleared and the test detected a different type, HPV 51.

Because she is ≥30 years, has a newly detected HPV 51 infection and normal cytology, her personalized immediate risk of CIN3+ is

1.8%.^†1

What about the other FDA-approved HPV tests?

Most FDA-approved HPV tests cannot identify which HPV type is causing the infection apart from HPV 16 and HPV 18: they report the other high-risk HPV types in a single, pooled result.^2,3 Most tests would have returned an HPV-positive result of undetermined type at baseline and at 1-year follow-up.³

With normal cytology and a repeated HPV-positive result of undetermined type, Maya’s immediate CIN3+ risk would have been overestimated at

4.1%^‡4

While a persistent infection with the same HPV type increases the risk for cervical precancer and cancer, testing positive for a different high-risk HPV type at two consecutive tests essentially resets a woman’s CIN3+ risk to that of a newly acquired HPV infection.^5,6

It occurs when an initial HPV infection is cleared by the immune system and then there is either a newly acquired infection or a previously acquired HPV infection that goes from being latent and undetectable, to being active and detectable.⁷

2

Based on the estimated immediate CIN3+ risk the ASCCP guidelines recommend a colposcopy.⁵

With an HPV test that can individually identify more HPV types:

Personalized immediate risk of CIN3+
1.8%¹

Return in 1 year^#8

What about the other FDA-approved HPV tests:

immediate risk of CIN3+
4.1%^‡4

Colposcopy⁸

A risk of precancer or cancer of 1.8% is below the colposcopy referral threshold.⁸

A pooled high-risk HPV test would have masked Maya’s HPV clearance and subsequent new HPV type detection, which would have overestimated Maya’s CIN3+ risk and likely led to a colposcopy recommendation instead of one-year follow-up.^1,4,8

By using an assay that individually identifies more HPV types, you could uncover an HPV clearance with new HPV type positivity and better manage your patients like Maya who may not need an immediate colposcopy.

I want to individually identify more high-risk HPV types

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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.

Take a deeper look at the clinical data on HPV clearance with new HPV type detection

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

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

Why HPV test results cannot be used as a biomarker for sexual history.

HPV clearance with new HPV detection can be confusing for some patients. Below are some key points to help you explain to your patients why HPV test results cannot be used as a biomarker for sexual history.

HPV is the most common sexually transmitted infection in the United States, with all high-risk types circulating in the community at all times. HPV is so common that almost everyone that is or has been sexually active gets exposed to it.⁹
Many women harbor multiple infections which come and go. HPV test results are not necessarily indicative of current sexual activity.⁷
It is possible to have a latent infection that is undetectable by a PCR HPV test for years. Over time the latent infection can rise to become detectable and appears to be a new infection, when in fact it arises from a prior sexual encounter many years previously.⁷
A study found that among women with new high-risk HPV detections (based on patient declaration):⁷
- 2 in 10 had a new sexual partner
- 7 in 10 were monogamous
- 1 in 10 were abstinent
There is no difference in new HPV detections between women who reported no recent sexual activity and women who have sex with the same partner.⁷

Why is HPV clearance with subsequent new HPV detection 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.^2,3

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.⁸

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.⁸

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.^2,6,10

*Names and/or medical information presented on this page do not represent real people or clinical information.
^†Based on results from the BD Onclarity™ Trial that studied precancer risk in 27,037 women ≥ 25 years with normal cytology.¹
^‡Based on data from women ≥ 25 years with HPV-positive NILM results in follow-up of HPV-positive NILM results.⁴
^#The ASCCP Risk-Based Management Guidelines recommend a follow-up HPV test after 1, 3 or 5 years depending on the 5-year risk of CIN3+.⁸
There is no data currently available showing the 5-year CIN3+ risk of HPV 51.

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. Stoler MH et al. Gynecol Oncol. 2019,153(1):26–33.
2. Bonde J et al. J Low Genit Tract Dis. 2020;24(1):1–13.
3. Salazar KL et al. J Am Soc Cytopathol. 2019;8(5):284–92.
4. Egemen D et al. J Low Genit Tract Dis. 2020;24(2):132–43.
5. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–7.
6. Bonde J et al. J Low Genit Tract Dis. 2021;25(1):27–37.
7. Paul P et al. J Infect Dis. 2021;223(8):1423–32.
8. Perkins RB et al. J Low Genit Tract Dis. 2020;24(2):102–31.
9. Genital HPV Infection Factsheet. CDC 2017. Accessed 2 August 2023.