Quest Diagnostic at Quest.com
 

FOR HER

Your dedication to saving women’s lives
is what drives us to offer

FDA-approved

Aptima® HPV
mRNA Assay

One of the most significant innovations in
cervical cancer screening in over a decade.

Know the facts about the Aptima HPV Test

  • Offers excellent sensitivity
  • Offers increased specificity2
  • FDA-approved for use with ThinPrep®
  • Aligns with cervical cancer screening guidelines
  • Requires only 1 mL of specimen2
  • Same price and coverage as DNA-based HPV tests
  • No increased costs to you or your patients
  • Only assay to genotype 16, 18/45 to identify almost
    all HPV types associated with cervical adenocarcinoma
The pivotal study, known as the CLEAR (Clinical Evaluation of Aptima HPV RNA) Trial was a prospective, multicenter clinical study that analyzed more than 11,000 women undergoing routine Pap testing at 18 US clinics. The CLEAR Trial comprised two arms:
  1. The ASCUS Study population included 939 women <21 years with ASCUS cytology results
  2. The NILM (Adjunct) Study population included 10,871 women <30 years with normal cytology results

With the Aptima HPV Test—FDA-approved for use in ThinPrep®
—you can focus on more clinically relevant results.

mRNA and Cervical Disease


For more information, contact your sales representative
or call 1-866-MYQUEST (1-866-697-8378).

The Aptima HPV Assay detects E6/E7 viral mRNA from 14 high-risk types of human papillomavirus in cervical specimens (in ThinPrep® Pap Test vials containing PreservCyt® Solution and collected with broomtype or cytobrush/spatula devices). The test is indicated to screen women ≥21 years with ASCUS cytology to determine the need for colposcopy, and to screen women ≥30 years for high-risk HPV types. This information with cytology history, other risk factors, and guidelines may be used to manage patients. See www.genprobe.com for more details.

The assay is not a substitute for regular cervical cytology screening. The results of this test are not intended to prevent women from proceeding to colposcopy. The assay has not been evaluated for managing HPV vaccinated women, women with prior ablative or excisional therapy, hysterectomy, who are pregnant, or have other risk factors. Aptima and other associated logos are registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States, and/or other countries.

REFERENCES
  1. Monsonego J, Hudgens MG, Zerat L, 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;129:691-701.
  2. Aptima HPV Assay (package insert), San Diego, CA: Gen-Probe Incorporated; 2011.
  3. Dockter J, Schroder A, Hill C, et al. Clinical performance of the Aptima HPV Assay for the detection of high-risk HPV and high-grade cervical lesions. J Clin Virol. 2009;45(S1):S55-S61.
  4. Szarewski A, Ambroisine L, Cadman L, et al. Comparison of predictors for high-grade cervical intraepithelial neoplasia in women with abnormal smears. Cancer Epidemiol Biomarkers Prev. 2008;17(11):3033-3042.
  5. Szarewski A, Mesher D, Cadman L, et al. Comparison of seven tests for high-grade cervical intraepithelial neoplasia in women with abnormal smears: the Predictors 2 study. J Clin Micro. 2012;50(6):1867-1873.
  6. Reuschenbach M, Clad A, von Knebel Doeberitz C, et al. Performance of p16INK4a-cytology, HPV mRNA, and HPV DNA testing to identify high grade cervical dysplasia in women with abnormal screening results. Gynecol Oncol. 2010;119(1):98-105.
  7. Clad A, Reuschenbach M, Weinschenk J, et al. Performance of the Aptima high-risk human papillomavirus mRNA assay in a referral population in comparison with Hybrid Capture 2 and cytology. J Clin Micro. 2011;49(3):1071-1076.
  8. Ratnam S, Coutlee F, Fontaine D, et al. Aptima HPV E6/E7 mRNA test is as sensitive as Hybrid Capture 2 Assay but more specific at detecting cervical precancer and cancer. J Clin Micro. 2011;49(2):557-564.
  9. Wu R, Belinson SE, Du H, 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.
  10. Cuzick J, et al. International Papillomavirus Conference; 2011. Data on file.
  11. Iftner T, et al. International Papillomavirus Conference; 2012. Data on file.
  12. Ovestad IT, Vennestrøm U, Andersen L, et al. Comparison of different commercial methods for HPV detection in follow-up cytology after ASCUS/LSIL, prediction of CIN2-3 in follow up biopsies and spontaneous regression of CIN2-3. Gynecol Oncol. 2011;123(2):278-283.
  13. de Sanjose S, Quint WG, Alemany L, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010;11(11):1045-1056.
  14. Adegoke O, Kulasingam S, Virnig B. Cervical cancer trends in the United States: a 35-year population-based analysis. J Woman’s Health. 2012;21(10):1031-1037.
  15. Guan P, Howell-Jones R, Li N, et al. Human papillomavirus types in 115,789 HPV-positive women: a meta-analysis from cervical infection to cancer. Int J Cancer. 2012;131(10):2349-2359.
  16. Arbyn M, Roelens J, Cuschieri K, et al. The Aptima HPV assay versus the Hybrid Capture 2 test in triage of women with ASC-US or LSIL cervical cytology: a meta-analysis of the diagnostic accuracy. Int J Cancer. 2013;132(1):101-108.
  17. Moscicki AB, Schiffman M, Kjaer S, Villa LL. Chapter 5: Updating the natural history of HPV and anogenital cancer. Vaccine. 2006;24(S3):42–51.