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Aptima HPV tests

At Hologic, we work tirelessly to improve early detection of cervical disease. The Aptima HPV assay, offers a unique screening approach by targeting high-risk HPV mRNA from the E6/E7 oncogenes. The Aptima HPV assay also offers the same excellent sensitivity and improved specificity compared to DNA-based tests.

In line with our commitment to improving women's health by providing a full line of advanced diagnostics, Hologic offers the Aptima HPV 16 18/45 genotype assay. The first FDA-approved test for genotyping human papillomavirus (HPV) types 16, 18 and/or 45 from women with Aptima HPV assay positive results.

About

Aptima HPV test

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 have show targeting E6/E7 mRNA identifies the presence and activity of a high-risk HPV infection.5,6 Aptima HPV assay utilizes the same excellent sensitivity and improved specificity compared to DNA-based tests allowing clinicians to maximize the benefits of screening while minimizing potential harm.

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 of available HPV test

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 CLEAR trial, 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.

Aptima HPV 16 18/45 genotype assay

Recent data suggests that while the incidence of cervical cancer has decreased since the 1970s, the prevalence of adenocarcinoma cases has risen approximately 32% in the same time frame.22

The 2012 consensus guidelines state that “The addition of HPV testing to cytology also enhances the identification of women with adenocarcinoma of the cervix and its precursors”.  The Aptima HPV 16 18/45 test was designed with the link to adenocarcinoma in mind.  Data suggests that up to 94% of cervical adenocarcinomas are linked to genotypes 16, 18, or 45—in fact, 12% were linked to type 45 alone.23 

Not only is HPV type 45 common in cervical adenocarcinomas, data also indicates that it is the third most common HPV genotype all invasive cervical cancers-including squamous cell carcinoma.24-25

Fortunately, HPV genotype 45 is fairly uncommon, identified in only 4% of women with normal cytology. By including HPV type 45 in addition to types 16 and 18, the Aptima HPV 16 18/45 Genotype assay may help identify more women at risk for cervical cancer with a minimal impact to colposcopy rates.24-25

Aptima HPV 16 18/45 genotype assay from Hologic — next generation technology, today.

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.
  • Align with cervical cancer screening guidelines.
  • Only 1 mL of specimen required.
  • Internal control.
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.
  22. Adegoke et al. J Women's Health. 2012, 21(10): 1031-1037
  23. Saslow et al. Am J Clin Pathol. 2012; 137(4):516-42.
  24. de Sanjose et al. Lancet 2010;11:1048-1056
  25. Guan et al. Intl J Cancer 2012;131:2349-2359