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    The Roche Cervical Cancer Screening Portfolio helps protect her
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There are limits in using cytology as a primary screening test. New strategies are needed.


Normal cytology doesn’t always mean cancer-free.

Up to one-third of cervical cancers occur in screened women with normal Pap cytology.1,2

Liquid-based cytology (LBC) screening has been useful in significantly reducing the incidence and mortality rate of cervical cancer.3 Despite having high specificity, cytology has lower sensitivity than HPV testing, resulting in missed disease in patients, including cases of high-grade disease.1,2,4


New strategies are needed to deliver improved patient care and avoid overtreatment.

Evidence supports moving to hrHPV testing for primary screening of cervical cancer.5

  • In primary screening, hrHPV testing was proven more sensitive than cytology for detecting CIN2+ and CIN3+.4
  • Pooled hrHPV testing has high sensitivity but lacks specificity, accurately identifying women harboring disease, but resulting in false identification of healthy women, leading to unnecessary colposcopy.6
  • Evidence supports the use of tests that identify genotype 16 or the combination of genotypes 16 and 18 to identify those at highest risk for cervical cancer.7
  • 70% of cervical cancers are caused by HPV genotypes 16 and 18.3
  • cobas® HPV Test identifies all high-risk genotypes together with individual results for the most aggressive HPV genotypes (16/18).


CINtec® PLUS Kit enhances sensitivity in cytology-based screening.

  • The adjunctive use of p16/Ki-67 dual staining provides a 43% increase in sensitivity to identify women who harbor CIN2+ lesions (93% vs. 65%).8
  • p16/Ki-67 testing could reduce referral to colposcopy by almost 50% while detecting the most severe cases of CIN3.9


CINtec® Histology Kit significantly improves diagnostic accuracy.10

  • 13% increase for detecting CIN2+ without a loss in specificity
  • 45% reduction in false-negative interpretations
  • Increases inter-observer agreement for diagnosing CIN2+ by 30%10

  • Acronyms:


1. Leyden WA, Manos MM, Geiger AM, et al. Cervical cancer in women with comprehensive health care access: attributable factors in the screening process. J Natl Cancer Inst. 2005;97:675-683.

2. Andrae B, Kemetli L, Sparén P, et al. Screening-preventable cervical cancer risks: evidence from a nationwide audit in Sweden. J Natl Cancer Inst. 2008;100:622-629.

3. Saslow D, Solomon D. Lawson HW, 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.

4. Whitlock EP, Vesco KK, Eder M, Lin JS, Senger CA, Burda BU. Liquid-based cytology and human papillomavirus testing to screen for cervical cancer: a systematic review for the U.S. Preventative Services Task Force. Ann Intern Med. 2011; 155:687-697.

5. Rijkaart DC, Berkhof J, Rozendaal L, et al. Human papillomavirus testing for the detection for high-grade cervical intraepithelial neoplasia and cancer: final results of the POBASCAM randomized controlled trial. Lancet Oncol. 2012; 13:78-88.

6. Cox JT, Castle PE, Behrens CM, et al. Comparison of cervical cancer screening strategies incorporating different combinations of cytology, HPV testing and genotyping for HPV 16/18: results from ATHENA HPV study. Am J Ob Gyn. 2012:in Press.

7. Wright T.C., Stoler M, Sharma A, Zhang G, Behrens C, Wright T.L., ATHENA Study Group. Evaluation of HPV-16 and HPV-18 genotyping for the triage of women with high-risk HPV+ cytology-negative results. Am J Clin Pathol. 2011;136:578-586.

8. Petry KU, Schmidt D, Scherbring S, et al. Triaging Pap cytology negative, HPV positive cervical cancer screening results with p16/Ki-67 dual-stained cytology. Gynecol Oncol. 2011;121(3):505-509.

9. Wentzensen N, Schwartz L, Zuna R.E., et al. Performance of p16/Ki-67 Immunostaining to Detect Cervical Cancer Precursors in a Colposcopy Referral Population. Clin Cancer Res 2012;18:4154-4162. Published Online First on June 6, 2012.

10. Bergeron C, Ordi J, Schmidt D, Trunk MJ, Keller T, Ridder R, European CINtec Histology Study Group. Conjunctive p16INK4a testing significantly increases accuracy in diagnosing high-grade cervical intraepithelial neoplasia. Am J Clin Pathol. 2010;133(3):395-406.