Cervical cancer portfolio resources

Clinical Guidelines

The cervical cancer screening and management guidelines outlined below are recommended by professional societies in the United States. Other countries are adopting and implementing guidelines according to their own developed policies and recommendations.

July 30, 2020 American Cancer Society Guidelines Update

Recommendations include an HPV test every five years for individuals with a cervix ages 25-65 as the preferred method of testing over the Pap test or the combination of Pap and HPV testing. Another significant change is for cervical cancer screening to begin at age 25. The previous ACS guideline, released in 2012, called for cervical cancer screening starting at age 21.

The new guidelines reflect the rapidly changing landscape of cervical cancer prevention in the United States and around the world, focusing on better outcomes, test efficiency and more simplified screening. Human papillomavirus (HPV) is the cause of nearly all cervical cancers. Primary HPV testing every 5 years is more effective than Pap cytology alone for cervical cancer prevention, and more efficient than co-testing, reducing the number of tests while providing comparable outcomes.1, 2

April 2, 2020—The ASCCP Risk Based Management Consensus Guidelines have now been published. Read here:

ASCO Secondary Prevention of Cervical Cancer Resource-Stratified Guideline: published in JGO DOI: 10.1200/JGO.2016.006577

US Preventive Services Task Force (USPSTF) Guidelines update August 21, 2018:

American College of Obstetrics & Gynecology Practice Advisory update August 2018:

Society of Gynecologic Oncology (SGO):

American Cancer Society (ACS):


Learn about HPV and disease progression to cervical cancer

Our educational video helps explain HPV and cervical cancer, and how an infection can progress to cervical disease.

How high-risk HPV can lead to cervical cancer
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Improving cervical cancer screening, triage and diagnostic testing with next-generation biomarker technology. A focus on the science of HPV has led to an evolution in cervical cancer screening strategies.

With today's scientific advancements and our current understanding of the science behind HPV, we no longer believe that the status quo in cervical screening is good enough. Roche continues to make significant investment in screening strategies, product development, and clinical study evidence, because we know that you expect this and that women deserve more. 

The Roche cervical cancer portfolio is unique in that it supports women along a continuum of care, enabling physicians to screen and diagnose disease, before invasive cancer ever develops. We help laboratories and clinicians by providing additional information about a patient's risk so that her care is more individualized, and there is evidence behind important treatment decisions. Giving a woman the right care at the right time will not only help protect her from the progression of disease, but can also help protect her from the risk or over- or under-treatment.

Journals and articles

Many published articles and papers support the advancement of science around HPV and cervical cancer prevention. The science behind HPV and its role in disease progression has opened up new pathways for patient management and care. Please see below for a summary of clinical study publications that have been significant in shaping and supporting today's understanding to guide clinical practice.

HPV and Cervical Cancer Screening and Prevention:


  • Safaeian M, et al. The IMPACT trial: human papillomavirus, cervical cytology and histopathological results from the baseline and 1-year follow-up phase, Am J Gynecol. 2021  (Accessed May 2021)
  • Simms et al., Impact of scaled up human papillomavirus vaccination and cervical screening and the potential for global elimination of cervical cancer in 181 countries, Lancet Oncology 2020–99: a modelling study, Volume 20, Issue 3, March 2019, Pages 394-407  (Accessed 1 June 2020)
  • 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.
  • 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.
  • 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 the ATHENA HPV study. Am J Ob Gyn. 2012:In Press.
  • Castle PE, Stoler MH, Wright TC Jr, Sharma A, Wright TL, Behrens CM. Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a subanalysis of the ATHENA study [published online August 23, 2011]. Lancet Oncol. doi:10.1016/S1470-2045(11)70188- 7.
  • 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.
  • 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(9):622-629.
  • Herzog TJ, Monk BH. Reducing the burden of glandular carcinomas of the uterine cervix. Am J Obstet Gynecol. 2007;197:566-571.
  • 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(9):675-683.
  • Bosch FX, de Sanjosé S. Chapter 1: Human papillomavirus and cervical cancer—burden and assessment of causality. J Natl Cancer Inst Monogr. 2003;31:3-13.

p16/Ki-67 Dual Staining in Cervical Cancer Screening:


  • Rossi PG, Carozzi F, Ronco G, Allia E, Bisanzi S, Gillio-Tos A, et al. p16/ki67 and E6/E7 mRNA Accuracy and Prognostic Value in Triaging HPV DNA-Positive Women. J National Cancer Inst.2021;113(3):292–300.
  • Wentzensen N., et al.,Clinical Evaluation of Human Papillomavirus Screening With p16/Ki-67 Dual Stain Triage in a Large Organized Cervical Cancer Screening Program JAMA Intern Med. 2019;179(7):881-888. doi:10.1001/jamainternmed.2019.0306. Published online May 13, 2019.
  • Clarke MA, Cheung LC, Castle PE, Schiffman M, Tokugawa D, Poitras N, Lorey T, Kinney W, Wentzensen N. Five-Year Risk of Cervical Precancer Following p16/Ki-67 Dual-Stain Triage of HPV-Positive Women. JAMA Oncol. 2019 Feb 1;5(2):181-186. doi: 10.1001/jamaoncol.2018.4270. PMID: 30325982; PMCID: PMC6439556.
  • T.C. Wright Jr. et al., Triaging HPV-Positive Women with p16/Ki-67 Dual-stained Cytology: Results from a Sub-study Nested into the ATHENA Trial. Gynecol Oncol. 2017 Jan;144(1):51-56. doi: 10.1016/j.ygyno.2016.10.031.
  • KU Petry et al., A model to evaluate the costs and clinical effectiveness of human papilloma virus screening compared with annual papanicolaou cytology in Germany. European Journal of Obstetrics & Gynecology and Reproductive Biology 212 (2017) 132–139.
  • Bergeron, C. et al., Prospective evaluation of p16/Ki-67 dual-stained cytology for managing women with abnormal Papanicolaou cytology: PALMS study results. Cancer Cytopathol. 2015 Jun;123(6):373-81. doi: 10.1002/cncy.21542. Epub 2015 Apr 17.
  • Wentzensen N., et al., p16/Ki-67 Dual Stain Cytology for Detection of Cervical Precancer in HPV-Positive Women. J Natl Cancer Inst. 2015 Sep 15;107(12):djv257. doi: 10.1093/jnci/djv257. Print 2015 Dec.
  • Killeen JL, Dye T, Grace C, Hiraoka M. Improved abnormal Pap smear triage using cervical cancer biomarkers. J Low Genit Tract Dis. 2014;18(1):1-7. DOI:10.1097/LGT.0b013e31828aeb39.
  • Ikenberg, H. et al., Screening for Cervical Cancer Precursors With p16/Ki-67 Dual-Stained Cytology: Results of the PALMS Study. J Natl Cancer Inst. 2013 Oct 16; 105(20): 1550–1557.
  • Wentzensen N., et al., Performance of p16/Ki-67 Immunostaining to Detect Cervical Cancer Precursors in a Colposcopy Referral Population. Clin Cancer Res. 2012 Aug 1;18(15):4154-62. doi: 10.1158/1078-0432.CCR-12-0270. Epub 2012 Jun 6.
  • Waldstrøm, M., et al., Evaluation of p16INK4a/Ki-67 Dual Stain in Comparison With an mRNA Human Papillomavirus Test on Liquid-Based Cytology Samples With Low-Grade Squamous Intraepithelial Lesion. Cancer Cytopathol. 2013 Mar;121(3):136-45. doi: 10.1002/cncy.21233. Epub 2012 Sep 17.
  • Schmidt D, Bergeron C, Denton KJ, Ridder R for the European CINtec Cytology Study Group. p16/Ki-67 dual-stain cytology in the triage of ASCUS and LSIL papanicolaou cytology: results from the European equivocal or mildly abnormal Papanicolaou cytology study. Cancer Cytopathol. 2011;119(3):158-166. doi: 10.1002/cncy.20140. Epub 2011 Mar 25.
  • 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. doi: 10.1016/j.ygyno.2011.02.033. Epub 2011 Mar 21.

p16 Immunohistochemistry in the Evaluation of Cervical Biopsies:


  • Wright et. al. The CERTAIN Study Results Adjunctive p16 Immunohistochemistry Use in Cervical Biopsies According to LAST Criteria, Am J Surg Pathol. 2021 epub ahead of print Apr 7; (Accessed May 2021).
  • Stoler MH, Wright TC Jr, Ferenczy A, Ranger-Moore J, Fang Q, Kapadia M, Ridder R. Routine Use of Adjunctive p16 Immunohistochemistry Improves Diagnostic Agreement of Cervical Biopsy Interpretation: Results From the CERTAIN Study. Am J Surg Pathol. 2018 Aug;42(8):1001-1009. doi: 10.1097/PAS.0000000000001072. PMID: 29697437.
  • Darragh TM, Colgan TJ, Cox JT, et al. The lower anogenital squamous terminology standardization project for HPV associated lesions: Background and consensus recommendations from the College of American Pathologists and the American Society for Colposcopy and Cervical Pathology. J Low Genit Tract Dis. 2012;16:205-242. Erratum in J Low Genit Tract Dis. 2013;17:368.
  • Bergeron, C., et al, Conjunctive p16INK4a Testing Significantly Increases Accuracy in Diagnosing High-Grade Cervical Intraepithelial Neoplasia. Am J Clin Pathol 2010;133:395-406. DOI: 10.1309/AJCPXSVCDZ3D5MZM
  • Galgano, M, et al, Using Biomarkers as Objective Standards in the Diagnosis of Cervical Biopsies. Am J Surg Pathol. 2010;34:1077–1087.
  • Ordi, J., et al. p16INK4a Immunostaining Identifies Occult CIN Lesions in HPV-positive Women. International Journal of Gynecological Pathology 2008; 28:90–97. DOI: 10.1097/PGP.0b013e31817e9ac5


  1. Screening for Cervical Cancer in Primary Care: A Decision Analysis for the U.S. Preventive Services Task Force. Agency for Healthcare Research and Quality (US) Kim et. al., JAMA. 2018;320:706‐714;
    Accessed 4 August 2020.
  2. Cervical Cancer Screening for Individuals at Average Risk: 2020 Guideline Update from the American Cancer Society, Fontham et. al.; Accessed 3 August 2020