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Aptima HPV Assay

The Aptima HPV assay offers a unique screening approach by targeting high-risk human papillomavirus (HPVmRNA from the E6/E7 oncogenes. The Aptima HPV assay offers the same excellent sensitivity and improved specificity as compared to DNA-based tests.

About

HPV is responsible for more than 99% of all cervical cancers, which is one of the most common types of cancer affecting women throughout the world.1-3

The Aptima HPV assay identifies high-risk HPV infections by targeting E6/E7 mRNA.4  Studies show that targeting E6/E7 mRNA identifies the presence and activity of a high-risk HPV infection.5,6 The Aptima HPV assay represents the next generation in cervical cancer screening - allowing clinicians to deliver maximum benefits to patients, while minimizing potential harm.

mRNA and Cervical Disease

Maximizing the benefits—excellent sensitivity

The Aptima HPV assay identifies those patients at greatest risk for developing cervical cancer, delivering the same excellent sensitivity to minimize false negative results. In fact, the Aptima HPV assay demonstrates the same excellent sensitivity as DNA-based HPV tests in numerous clinical studies involving over 50,000 women worldwide.4,7-21

Clinical sensitivity for CIN3+

Minimizes potential harm — improves specificity

Due to false-positives, cervical cancer screening can potentially result in the over-treatment of patients. To help minimize this potential harm, the Aptima HPV assay offers improved specificity, reducing the rate of false positive results. In the NILM (negative for intraepithelial lesion or malignancy) arm of the clinical trial to support FDA approval, the Aptima HPV assay showed 24% fewer false positive test results compared to DNA-based testing.4. With Aptima HPV, clinicians can more accurately target the right patients for coloposcopy. 

Fewer false-positive results*


 

 

Features

Unique features of the Aptima HPV assay include:

  • The same excellent sensitivity.
  • Increased specificity compared to DNA-based tests.
  • FDA-approved for use with the ThinPrep Pap test.
  • Aligned with cervical cancer screening guidelines.
  • Only 1 mL of specimen required.
  • Internal control.
Regulatory

The Aptima HPV assay is FDA-approved for in vitro diagnostic use. 

For additional availability in other countries beyond the U.S., please contact your local sales representative or distributor.

References
  1. Doorbar, J. Clin Sci (Lond). 2006; 110(5):525-41.
  2. Monsonego J., et al. Int J Cancer. 2004; 108(3):329-33. Erratum in: Int J Cancer. 108(6):945.
  3. Walboomers, J. M. J Pathol. 1999; 189:12-19.
  4. Aptima® HPV Assay package insert #503789 Rev A 2013.
  5. Tinelli A, et al. Curr Pharm Biotechnol. 2009 Dec;10(8):767-71
  6. Cuschieri K, et al. J Med Virol. 2004 May;73(1):65-70
  7. Szarewski A, et al. Cancer Epidimiol Biomarkers Prev. 2008; 17(11): 3033-42
  8. Dockter J, et al. J Clin Virol. 2009; 45(S1): S55-S61
  9. Ruschenbach M, et al. Gynecol Oncol. 2010; 119(1): 98-105.
  10. Clad A, et al. J Clin Microbiol. 2011; Mar;49(3):1071-6.
  11. Ratnam S, et al. J Clin Micro. 2011; (49(2): 557-64
  12. Ovestad I, et al. Gynecol Oncol. 2011; 123(2): 278-283
  13. Szarewski A, et al. J Clin Micro. 2012; 50(6): 1867-73
  14. Eaton B, et al.. Poster presented at IPV 2012.
  15. Cushieri K, et al. J Clin Virol 2014, 59: 104-108.
  16. Cubie HA, et al. J Clin Pathol 2014, 67:458–463.
  17. Wu R, et al. Intl J Gyn Cancer. 2010; 20(8): 1411-14
  18. Monsonego J, et al. Intl J Cancer. 2011; 129: 691-701
  19. Infner,T, et al. Comparison of Aptima and HC2 in a routine screening trial in Germany with follow up [abstract].
  20. Cuzick, J et al. Br J Cancer. 2013 March 5; 108(4): 908–913.
  21. Nieves L, et al. Int J Gynecol Cancer 2013, 23:513-518.