Aptima® HPV 16 18/45
Genotype Assay

A Targeted Approach

Aptima HPV graphs R0 1

“We confirmed the utility of 16/18 genotyping in cervical cancer screening strategies, while pooled detection of non-16/18 genotypes is sufficient”
– Monsonego, et al., ATHENA trial2

ASCCP Management Genotyping Guidelines3*

“Ultimately, the placement of genotypes into risk strata will require consensus from multiple prospective and observational studies and modeling studies that provide risk estimates and corresponding number of colposcopy referrals in order to provide an accurate risk-benefit analyses.”
– Stoler, et al.4

“Including additional genotypes to HPV 16/18 for immediate colposcopy in HPV primary screening algorithms is ultimately a question of balance: do additional colposcopies represent a significant benefit to patients who would otherwise return in 1 year for a follow-up versus the risk of loss to follow-up and lack of treatment of prevalent CIN2/3.”
– Stoler, et al.4

*Full genotyping recommendations can be found in the ASCCP app.

HPV Clearance and Progression

Few HPV+ will progress to ≥CIN35
Aptima HPV graphs R0 3

“. . . . many cases of CIN3/AIS would not progress to cancer if left untreated . . . . Therefore, true cancer risk posed by various HPV types can be misspecified even when estimated by the prospective risk of CIN3/AIS . . . .”
– Demarco, et al.7

HPV Genotypes in Cases of CIN3+ and Cervical Cancer

HPV types 16, 18 and 45 are associated with up to 94% of HPV-related cervical adenocarcinomas. HPV type 45 is the third most common HPV type in invasive cervical cancers.8,9

CIN3+ Cases by Genotype

CIN3+ Cases by Genotype
Squamous & Adenocarcinoma by Genotype8
Squamous & Adenocarcinoma by Genotype

HPV type 16 associated with8:

  • 62% of Squamous Cell Carcinomas
  • 50% of Adenocarcinomas

HPV types 16, 18, 45 associated with8:

  • Up to 75% of Squamous Cell Carcinomas
  • 94% of HPV-related cervical adenocarcinomas
HPV type 458,9:
  • Third most common HPV type in invasive cervical cancer
  • Identifies more women at risk for adenocarcinoma, with minimal impact to colposcopy

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1. Aptima HPV assay [package insert]. AW-12820 San Diego, CA; Hologic, Inc., 2019.
2. Monsonego, et al. Prevalence of high-risk human papilloma virus genotypes and associated risk of cervical precancerous lesions in a large U.S. screening population: Data from the ATHENA trial. Gynecologic Oncology. 2015;137(1):47-54. doi.org/10.1016/j.ygyno.2015.01.551.
3. Perkins, et al. 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors. J Low Genit Tract Dis. 2020;24:102-131
4. Stoler, et al. Stratified risk of high-grade cervical disease using onclarity HPV extended genotyping in women, ≥25 years of age, with NILM cytology. 2019;153(1):26-33. doi.org/10.1016/j.ygyno.2018.12.024.
5. Adapted from: Schiffman M et al. Human papillomavirus testing in the prevention of cervical cancer. J Natl Cancer Inst. 2011;103(5):368-83. doi:10.1093/jnci/djq562
6. McCredie MR, et al. Natural history of cervical neoplasia and risk of invasive cancer in women with cervical intraepithelial neoplasia 3: a retrospective cohort study. Lancet Oncol. 2008;9(5):425-34. doi:10.1016/S1470-2045(08)70103-7.
7. Demarco, et al. A study of type-specific HPV natural history and implications for contemporary cervical cancer screening programs. EClinicalMedicine. 2020;22. doi: 10.1016/j.eclinm.2020.100293.
8. de Sanjose S, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010;11(11):1048-1056.
9. Hopenhayn C, et al. Prevalence of human papillomavirus typesin invasive cervical cancers from 7 US cancer registries before vaccine introduction. J Low Genit Tract Dis. 2014;18(2):182-189. doi:10.1097/LGT.0b013e3182a577c7