Aptima® HPV Assay

Identify the presence and activity of a high-risk HPV infection

While nearly all sexually active women and men who are not vaccinated will have an HPV infection at some point
in their lives, relatively few will go on to develop cancer. 1 Thus, an optimal screening strategy should identify cervical cancer precursors likely to progress to invasive cancers, while avoiding detection and unnecessary treatment of transient HPV infection and its associated noncancerous lesions.2 With the extension of recommended intervals between cervical cancer screenings, it has become all the more important to accurately identify at-risk patients.

A Targeted Approach 3-7

The Aptima® HPV assay targets E6/E7 mRNA.
Studies have shown mRNA identifies the presence and activity of a high-risk HPV infection. HPV DNA tests only identify the presence of any of the 14 high-risk HPV types.
E6/E7 mRNA expression is indicative of the HPV infections most likely to lead to disease. 

Cervical Cancer Progression Model

The Aptima® HPV assay, therefore, identifies high-risk HPV infections that are present and active.

Maximizing the Benefits and Minimizing the Harms 2,3,8-19

HPV Test Clinical Sensitivity for ≥CIN3
The Aptima® HPV assay provides the same excellent sensitivity you’ve come to expect from DNA-based tests.

Screening Population

HPV Test Clinical Sensitivity for ≥CIN2
mRNA-based tests show equivalent sensitivity to DNA-based tests with superior specificity.

Screening Population

  • Minimize difficult patient conversations
  • Reduce the potential for overtreatment
  • Minimize the unnecessary cost to the patient

HPV Viral mRNA 20

  • Tests that target only the L1 gene are detecting an area that is not needed for disease progression and that can be deleted during integration.
  • As HPV DNA integrates into human DNA the L1 region can be deleted.
  • HPV assays that only target the L1 region are at risk for false negative results.
The Aptima HPV assay is designed for sensitive detection of HPV oncogenic activity.10
Aptima HPV3
HPV Viral mRNA

Years of Long-Term Results16,17, 21-23

mRNA based HPV assay shows safety over 10 years of longitudinal data.

Reid - 3 Years

“After 3-years of follow-up, women negative by either HPV test had a very low risk for CIN2+ (<0.3%)…”

Cook- 4 Years

“There was no significant difference in CIN2+ detection for AHPV vs. HC2 at baseline or at 48 months.”

Forslund - 7 Years

“The observed performance of the HPV-mRNA assay suggests that the evaluated assay is non-inferior to HPV-DNA testing and can be used in cervical screening programs that target women above 30 years of age for 5-7 yearly screening.”

Strang - 10 Years

“Our study found that, among this population, a negative baseline HPV test by any one of the three assays used in the HPV FOCAL Trial (HC2, CG, or AHPV), resulted in statistically similar CIN2+ and CIN3+ detection over ten years follow-up.”

Learn more about our HPV 16 18/45 Genotyping Assay

1. Genital HPV Infection –CDC Fact Sheet. Published July 2017. Accessed September 2, 2020. https://www.cdc.gov/std/hpv/HPV-FS-July-2017.pdf.
2. Saslow D, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology Screening Guidelines for the Prevention and Early Detection of Cervical Cancer. Am J Clin Pathol. 2012;137:516-542.
3. Aptima HPV Assay [package insert]. AW-12820, Rev 004. San Diego, CA: Hologic, Inc.; 2020.
4. Tinelli A, et al. HPV viral activity by mRNA HPV molecular analysis to screen the transforming infections in precancer cervical lesions. Curr Pharm Biotechnol. 2009;10(8):767-771.
5. Cuschieri K, et al. Human Papillomavirus Type Specific DNA and RNA Persistence–Implications for Cervical Disease Progression and Monitoring. J Med Virol. 2004;73(1):65-70.doi:10.1002/jmv.20062.
6. Doorbar J. Molecular biology of human papillomavirus infection and cervical cancer. Clin Sci (Lond). 2006 May;110(5):525-41. doi: 10.1042/CS20050369. PMID: 16597322.
7. Rebolj M, et al. Extension of cervical screening intervals with primary human papillomavirus testing: observational study of English screening pilot data BMJ 2022; 377 :e068776 doi:10.1136/bmj-2021-068776
8. Wu R, et al. Human papillomavirus messenger RNA assay for cervical cancer screening: the Shenzhen Cervical Cancer Screening Trial I. Int J Gynecol Cancer. 2010;20(8):1411-1414.
9. Ratnum S, et al. Aptima HPV E6/E7 mRNA test is as sensitive as hc2 Assay but more specific at detecting cervical precancer and cancer. J Clin Microbiol. 2011;49(2):557-564.
10. Monsonego J, et al. Evaluation of oncogenic human papillomavirus RNA and DNA tests with liquid-based cytology in primary cervical cancer screening: the FASE study. Int J Cancer. 2011,129(3):691-701.
11. Iftner T, et al. GAST: German Aptima Screening Trial. Comparison of Aptima and hc2 in routine screening in Germany. Symposium presentation at EUROGIN 2012.
12. Cuzick J, et al. Comparing the performance of six human papillomavirus tests in a screening population. British J Cancer. 2013;108:908-913.
13. Nieves L, et al. Primary Cervical Cancer Screening and Triage Using an mRNA Human Papillomavirus Assay and Visual Inspection. Int J Gynecol Cancer. 2013;23:513-518.
14. Iftner T, et al. Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany. J Clin Microbiol. 2015;53(8):2509-2516.
15. Muangto T, et al. Experience of combined liquid based cervical cytology and high-risk HPV mRNA for cervical cancer screening in Thammasat University Hospital. Asian Pac J Cancer Prev. 2016;17(9):4409-4413.
16. Reid et al. Human Papillomavirus Oncogenic mRNA Testing for Cervical Cancer Screening. Am J Clin Pathol, 2015;144:473-483
17. Cook et al., Aptima HPV Assay versus Hybrid Capture® 2 HPV test for primary cervical cancer screening in the HPV FOCAL trial J. Clin. Virol. 2017;87:23–29
18. Cook et al. Cobas 4800 HPV and Hybrid Capture 2 comparison at baseline and 48 months in the HPV Focal trial. Poster presented at IPV 2017.
19. Rebolj et al. A daunting challenge: Human Papillomavirus assays and cytology in primary cervical screening of women below age 30 years. EU J of Cancer (2015) 51, 1456-1466.
20. Morris BJ. Clin Chem Lab Med. 2005;43(11):1171-7. doi:10.1515/ CCLM.2005.203.
21. Cook et al., Comparative performance of human papillomavirus messenger RNA versus DNA screening tests at baseline and 48 months in the HPV FOCAL trial. J. Clin. Virol., 2018;108:32-37. https://doi.org/10.1016/j.jcv.2018.09.004 26.
22. Forslund O, et al. HPV-mRNA and HPV-DNA detection in samples taken up to seven years before dysplasia of cervix uteri. Int J Cancer. 2018; doi: 10.1002/ijc.31819.
23. Strang T, et al. Long-term cervical precancer outcomes after a negative DNA-or RNA-based human papillomavirus test result. Am J ObstetGynecol. 2021 Nov;225(5):511.e1-511.e7. doi: 10.1016/j.ajog.2021.05.038