Shifting to HPV primary screening requires reliable HPV tests

Official guidelines recommend HPV primary screening for cervical cancer prevention.

The introduction of cytology-based screening – or Pap smear – in the 1940s has largely contributed to reducing the mortality of cervical cancer.^1,2

Today, because of its proven clinical superiority in cervical cancer prevention, the WHO strongly recommends
HPV primary testing over cytology for screening programmes.²
HPV-based screening compared to cytology-based screening provides a greater protection against invasive cancer,
allows for longer screening intervals for women with negative screening results, and supports self-collection.^3-6

The shift to HPV primary screening makes it essential to use reliable HPV tests that are
clinically-validated for longer screening intervals and approved to use with self-collected
samples and in a vaccinated population.

Choose BD Onclarity™ HPV Assay.

Flexibility in screening paradigm and sample type

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Results you can trust

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Greater protection against cervical disease

HPV primary screening offers:

60–70% greater protection

against invasive cancer compared to cytology-based screening.⁷

increased long-term protection

against cervical cancer, even in vaccinated populations.^7,8

Extended genotyping may enhance clinical management by providing specific, actionable insights to assist in reducing patient call-backs and unnecessary colposcopies.⁹

Improving patient management
with extended genotyping
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Longer screening intervals

A woman is at “low risk” for a longer period after a negative HPV test than after a negative cytology test.^2,10,11

Cumulative CIN3+ risk following a negative HPV test or normal cytology at entry¹⁰

The cumulative CIN3+ risk is similar 10 years after a negative HPV test and 3 years after negative cytology (0.3%).¹⁰

Adapted from Gilham C et al. 2019.¹⁰

A screening interval of up to 10 years with HPV primary testing shows greater benefits than cytology-based screening.^2,11

Possibility to use self-collection

Self-collection can potentially extend screening coverage by increasing participation rates and represents a unique opportunity for expansion to hard-to-reach populations.^5,6

What is self-collection?

Because HPV is present both in
vaginal and cervix samples,
HPV primary screening is
compatible with
self-collection, which is not the
case with cytology.^4-6

When used with PCR-based HPV tests,
cervical cancer screening using
self-collected vaginal samples
demonstrated similar performance
compared to clinician-collected cervical samples.^12,13

HPV testing on self-collected samples is an integral part of the strategy to eliminate
cervical cancer as a public health problem in Europe for non- or under-screened women.⁵

More women screened means less cases of cervical cancer.^6,12

The importance of
self-collection
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Supporting and monitoring HPV vaccination

The superiority of HPV primary screening is also observed in a population with high vaccine uptake,⁸ supporting the global WHO strategy of combined vaccination and screening programmes.²

There are three different types of HPV vaccines:

Bi-valent HPV vaccine

Protects against hrHPV genotypes 16 and 18.^14,15
Initially approved by the EMA in 2007 and the FDA in 2009.^14,15
Voluntary withdrawn from the US in 2016.

4-valent HPV vaccine

Protects against two hrHPV genotypes (HPV 16 and 18) and two low-risk genotypes* (HPV 6 and 11).^16,17
Initially approved by the EMA and the FDA in 2006.^16,17
No longer distributed in the US.

9-valent HPV vaccine

Targets the same genotypes as the 4-valent vaccine and 5 additional hrHPV genotypes HPV 31, 33, 45, 52 and 58.^18,19
Approved by the FDA in 2014 and by the EMA in 2015.^18,19

While the 9-valent HPV vaccine is now exclusively used in many countries, women who received the earlier vaccines have now entered the screening population.

Additionally, as the vaccinated population increases, HPV 16 and 18 (high-risk genotypes covered by the bi-valent, 4-valent and 9-valent vaccines) are decreasing in prevalence.²⁰

HPV vaccination is constantly reshaping the HPV landscape. HPV genotype testing remains an important tool to help stratify risk and enhance patient management.²⁰

As the vaccinated
population increases,
HPV 16 and 18
are decreasing in
prevalence.²⁰

HPV 16/18

xGT

HPV extended genotyping may help monitor the changes in prevalence of hrHPV types.

Vaccinated women are not protected from
all hrHPV GENOTYPES.

A 50% vaccine coverage of 13-19-year-old girls induced an

83%
reduction

in HPV 16 and 18, as well as 54% reduction in HPV types 31, 33 and 45.²¹

A1 - 83%

What else can extended genotyping do for your patients?

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BD supports the shift to HPV testing as a primary screening test with an accurate HPV test and a reliable triage method to further help guide patient management with precision.

Reliable triage methods

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*According to current scientific knowledge, HPV 6 and 11 are responsible for genital warts and not involved in cervical disease.

CIN2+, cervical intraepithelial neoplasia grade 2 or higher; CIN3+, cervical intraepithelial neoplasia grade 3 or higher; EMA, European Medicines Agency; FDA, Food and Drug Administration; HPV, human papillomavirus; hr, high-risk; Pap, Papanicolaou; PCR, polymerase chain reaction; US, United States; WHO, World Health Organization; xGT, extended genotyping.

1. Adegoke O et al. J Womens Health. 2012;21(10):1031–7.
2. World Health Organization. WHO Guideline for Screening and Treatment of Cervical Pre-Cancer Lesions for Cervical Cancer Prevention - Second Edition. 2021.
3. Marth C et al. Ann Oncol. 2017;28(Suppl 4):iv72–iv83.
4. Maver PJ and Poljak M. Clin Microbiol Infect. 2020;26(5):579–83.
5. Arbyn M et al. Int J Cancer. 2021;148(2):277–84.
6. Lozar T et al. Int J Womens Health. 2021;13:841–59.
7. Ronco G et al. Lancet. 2014;383(9916):524-32.
8. Canfell K et al. PLOS Med. 2017;14(9):e1002388.
9. Bonde JH et al. J Low Genit Tract Dis. 2020;24(1):1–13.
10. Gilham C et al. Health Technol Assess. 2019;23(28):1-44.
11. European Commission. European Guidelines for Quality Assurance in Cervical Cancer Screening - Second Edition, Supplements. 2015.
12. Arbyn M et al. BMJ. 2018;363:k4823.
13. Rohner E et al. J Clin Microbiol. 2020;58(3):e01443-19.
14. European Medicines Agency. Cervarix Product information. 2021.
15. Food and Drug Administration. Cervarix Package insert.
16. European Medicines Agency. Gardasil Product information. 2022.
17. Food and Drug Administration. Gardasil Package insert.
18. European Medicines Agency. Gardasil 9 Product information. 2022.
19. Food and Drug Administration. Gardasil 9 Package insert.
20. Wright TC et al. Gynecol Oncol. 2019;153(2):259–65.
21. European Centre for Disease Prevention and Control. Guidance on HPV vaccination in EU countries: focus on boys, people living with HIV and 9-valent HPV vaccine introduction. 2020.

Shifting to HPV primary screening requires reliable HPV tests

As the vaccinated population increases, HPV 16 and 18 are decreasing in prevalence.20

xGT

HPV extended genotyping may help monitor the changes in prevalence of hrHPV types.

Vaccinated women are not protected from all hrHPV GENOTYPES.

83% reduction

As the vaccinated
population increases,
HPV 16 and 18
are decreasing in
prevalence.²⁰

Vaccinated women are not protected from
all hrHPV GENOTYPES.

83%
reduction