Aptima HPV Test & Adenocarcinoma

― Aptima HPV Test

HPV is responsible to a great extend (>99%) for cervical cancer1-3.

Aptima HPV Test detects high risk HPV types by aiming at the area Ε6/Ε7 of the virus mRNA 4.  Research has proven that detecting area Ε6/Ε7 of the virus mRNA suggests the presence of an active HPV infection 5,6. A large number of clinical studies performed on more than 50,000 women have proven that Aptima HPV Test has the same high sensitivity and better specificity than HPV DNA Tests 4,7-21.

Aptima HPV Test detects women who run a high risk to suffer from cervical cancer and due to its high sensitivity it minimizes false negative results.

On the other hand, false positive results may lead to overtreatment.  Aptima HPV Test offers improved specificity, therefore reduces significantly the number of false positive results.   In the CLEAR study, Aptima HPV Test reduced by 24% the number of false positive results 4.

― Aptima HPV 16 18/45 Test

Recent data have shown that the incidence of cervical cancer has reduced during the last 50 years, while, on the same time period, cervical adenocarcinoma population has a 32% increase 22.

Aptima HPV 16 18/45 was designed in order to detect adenocarcinoma.  Clinical studies have shown that up to 94% cases of cervical adenocarcinoma are connected to types 16,18 or 45. More specifically, 12% of those cases are connected with type 45 of the virus 22.

It is a fact, though, that type 45 is not only common on all adenocarcinomas, but also that it is the third more frequent type in all invasive types of cervical cancer, as studies have shown 23-24.

Therefore, detecting type 45 of the virus with the help of Aptima 16 18/45 Test makes possible to detect more women who run an increased risk to suffer from cervical cancer 23-24.



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  Saslow et al. Am J Clin Pathol. 2012; 137(4):516-42.
23  de Sanjose et al. Lancet 2010;11:1048-1056
24  Guan et al. Intl J Cancer 2012;131:2349-2359
See more at: http://www.hologic.com/products/clinician-diagnostic-solutions/cervical-health/aptima-hpv-tests#sthash.YqKKCo0W.dpuf