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The devil is in the details.

Get the facts. Know her risk.

Some hrHPV genotypes incur higher risk of precancer than others.1

Addressing the need for enhanced risk stratification

As the inclusion of HPV testing with Pap cytology for screening results in identification of more women at high risk, a new limitation is emerging — the lack of enhanced risk stratification that can identify those women who require more aggressive management.2

Current practice can involve repeating both Pap cytology and pooled hrHPV DNA testing in 12 months for women with normal cytology and a positive hrHPV DNA result instead of referring them for colposcopy. This approach, while an improvement on cytology alone in the early detection of precancer or cervical cancer, remains limited by:

  • Lack of HPV 16/18 genotype-specific results, which allows for risk stratification
  • Delays in clinical intervention for those at highest risk
  • Uncertainty and anxiety on the part of both physician and patient when the patient has normal cytology and a positive hrHPV DNA result

HPV 16/18 genotyping identifies women at the greatest risk of ≥CIN3.

Rate of ≥CIN3 by hrHPV status

10-year cumulative incidence rate of CIN3 by hrHPV status2

10-year Cumulative Incidence Rate of CIN3 by hrHPV Status

Women with HPV 16 and 18 are at greatest risk of developing high-grade cervical lesions2

In a seminal study of 20,810 women in the Kaiser Permanente healthcare system, in the population of women with normal cytology, those who were HPV 16 positive and those who were HPV 18 positive were shown to be at the highest risk of developing ≥CIN3.

Discover a woman’s risk for ≥CIN2.

Role of persistence of HPV genotypes in development of ≥CIN3

12-year risk of ≥CIN3 in Danish women with normal cytology and persistent hrHPV8

12-year Risk of ≥CIN3 in Danish Women with Normal Cytology and Persistent hrHPV

Women who had persistent HPV 16 infection had an approximately 50% 12-year risk of ≥CIN3.

  • Acronyms:


1. cobas® 4800 HPV Test US package insert. April 2016.

2. Khan MJ, Castle PE, Lorincz AT, et al. The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst. 2005;97(14):1072-1079.

3. The American Congress of Obstetricians and Gynecologists. ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists: Screening for Cervical Cancer. November, 2012.

4. Bosch FX, de Sanjosé S. Human papillomavirus and cervical cancer — burden and assessment of causality. J Natl Cancer Inst Monogr. 2003;31:3-13.

5. Bulk S, Berkhof J, Bulkmans NW, et al. Preferential risk of HPV16 for squamous cell carcinoma and of HPV18 for adenocarcinoma of the cervix compared to women with normal cytology in The Netherlands. Br J Cancer. 2006;94(1):171-175.

6. Ault KA, Joura EA, Kjær SK, et al. Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine. Int J Cancer. 2011;128(6):1344-1353.

7. de Sanjosé S, Quint WG, Alemany L, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010;11(11):1048-1056.

8. Kjær SK, Frederiksen K, Munk C, Ifner T. Long-term absolute risk of cervical intraepithelial neoplasia grade 3 or worse following human papillomavirus infection: role of persistence. J Natl Cancer Inst. 2010;102(19):1478-1488.-