Benefits of HPV genotyping | BD Onclarity | womens-health-solutions.bd.com

Meet Tianna*

35 years old
No medical conditions
Lives a healthy lifestyle and believes in the importance of cervical cancer screening
Has had Pap smears every 3 years from age 21 to 29 and co-testing with HPV and Pap every five years starting at age 30

Tianna recently moved to a new city and found a new OB/GYN where she was offered an HPV test that provided more detailed results.

Cervical cancer screening history

Past test results:

Normal cytology
Negative for HPV 16 and 18
Negative for high-risk HPV pool

Current results:

Normal cytology
Negative for HPV 16 and 18 and all other high-risk types
Positive for HPV 31

Her cytology results were once again normal, but her HPV test results showed an infection with HPV 31.

“I was worried when I first found out that I had HPV 31, one of the most risky types of HPV, and what it meant for my risk of cervical precancer. But my OB/GYN was very supportive and we were quickly able to discuss a plan”*

Normal cytology

HPV 16-

HPV 18-

HPV 31+

Take a look at Tianna's lab report

1

So, let’s start by looking at Tianna’s immediate risk for cervical precancer and cancer (CIN3+ risk)^1,2

With an HPV test that can individually identify HPV 31

Tianna’s OB/GYN was able to individually identify HPV 31 and provide a more precise assessment of her risk of developing cancer.

Because she is ≥30 years, has HPV 31 and normal cytology, her personalized immediate risk of CIN3+ is

8.4%^†2

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. Whether it’s HPV 31 or HPV 52, any HPV test other than BD Onclarity™ HPV Assay would have returned a HPV-positive result of undetermined type.^3-8

With a pooled HPV-positive result, Tianna’s immediate risk of CIN3+ would have been underestimated at

2.1%^‡9

Because different HPV types carry different risk for precancer and cancer, using a test that can individually identify HPV 31 offers a more precise assessment of Tianna’s immediate risk of CIN3+ compared to using an HPV test with pooled results.¹⁰

2

Now, based on the patient's immediate risk for CIN3+, what management would be recommended?

With an HPV test that can individually identify HPV 31:
personalized immediate risk of CIN3+
8.4%²

Colposcopy¹

With any other FDA-approved HPV test:
immediate risk of CIN3+
2.1%.^‡9

1 year follow-up¹

A risk of precancer of 8.4% calls for colposcopy.¹
A pooled high-risk HPV test would have masked Tianna’s true risk of cervical precancer, which would have likely led to a 1-year follow-up recommendation instead of an immediate colposcopy.^1,2,9,10

By using an assay than can individually identify more HPV types, including HPV 31, you can offer patients like Tianna a more precise cervical cancer risk assessment compared to an HPV test with grouped results.^1,2,9,10

Are you ready to start identifying HPV 31?

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Let's take a deeper look at the clinical data on HPV 31

In a multicenter clinical trial involving 33,000 patients, the immediate risk of having precancer or cancer among women aged 30 with normal cytology and positive for HPV 31 was 8.4%.²
This is similar to the risk associated with HPV 16 and is 3 times higher than the risk associated with HPV 18.²

Immediate risk of CIN3+ disease by HPV genotype in women ≥ 30 years with normal cytology²

Adapted from Stoler MH et al. Gynecol Oncol. 2019,153(1):26–33.

How was this trial designed?

Learn more

Why is HPV 31 not distinguished in the current ASCCP Risk-Based Management guidelines?

Individually identifying HPV 31 has been possible since 2020, when the first and only HPV test with extended genotyping (the ability to individually identify high risk HPV types beyond 16 and 18) was approved by the FDA.

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. At that time, the available assays only had partial HPV genotyping, which means that they could individually detect HPV 16 and HPV 18 and grouped the other 12 high-risk HPV types in a pool – identifying them together in a single result and not distinguishing between them.^1,9

To this date, only one FDA-approved HPV test has extended genotyping and can provide a result for HPV 31.^3-8

However, 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.

Now that we know that HPV 31 poses a higher risk of precancer as compared to HPV 18,¹ it is time to screen for it – so that every patient can be managed based on her personal risk.

You screen for HPV 16 and 18 – so why not HPV 31?

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*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.²
^‡Based on data from HPV-positive women ≥ 25 years with normal cytology who don’t have HPV 16 or HPV 18 infection.⁹

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. Perkins RB et al. J Low Genit Tract Dis. 2020;24(2):102–31.
2. Stoler MH et al. Gynecol Oncol. 2019,153(1):26–33.
3. digene^® HC2 High-Risk HPV DNA Test Package Insert.
4. Aptima™ HPV Assay US Package Insert.
5. Cervista™ HPV HR US Package Insert.
6. cobas^® HPV for 4800 System US Package Insert.
7. cobas^® HPV for 6800/8800 System US Package Insert.
8. BD Onclarity™ HPV Assay US Package Insert [8089894].
9. Egemen D et al. J Low Genit Tract Dis. 2020;24(2):132–43.
10. Bonde J et al. J Low Genit Tract Dis. 2020;24(1):1–13.

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

Meet Tianna*

Cervical cancer screening history

Are you ready to start identifying HPV 31?