Our educational video helps explain HPV and cervical cancer, and how an infection can progress to cervical disease.
The cobas® HPV test is clinically validated for use on the range of cobas® 4800/6800/8800 Systems, bringing unprecedented automation and throughput capabilities to HPV DNA screening.
We offer a consolidated assay menu, backed by our extensive experience and expertise in test design and optimization. Our commitment to robust performance standards demonstrates an unparalleled dedication to thorough data analysis and validation, delivering confidence with every result. Click here to learn more about our continued investment in new assay solutions and expanded menu offering.
The ATHENA HPV trial was a large, prospective clinical study evaluating the performance of the cobas® HPV Test in three relevant populations: women with ASC-US cervical cytology, women with normal cervical cytology, and an overall screening population (25+ years) to explore HPV as a first-line test (ongoing longitudinal 3 year study). With over 47,000 women enrolled, ATHENA also set out to evaluate the medical value of testing for pooled hrHPV DNA as well as genotypes 16 and 18 individually.1
ATHENA Key Findings:
The cobas® HPV Test was clinically validated in ATHENA, the first screening trial for registration that evaluated simultaneous real-time genotyping of 12 pooled hrHPV genotypes, plus HPV 16 and HPV 18 individually. The ATHENA trial evaluated the performance of the cobas® HPV Test in multiple clinical situations, including ASC-US triage and co-testing.2
ATHENA not only validated the cobas® HPV Test as comparable to the current standard of pooled hrHPV testing within the ASC-US population, but the trial also quantified risk of precancer and cervical cancer in HPV 16+ and/or HPV 18+ women who had ASC-US or who had normal cytology. Based on the results from the ATHENA study, the optimal primary screening strategy focuses medical attention on women with HPV 16 and HPV 18 genotypes, and triages other high-risk genotypes, balancing detected cases and intervention.3,4 HPV DNA testing permits confident extension of screening intervals and identifies women who can return to routine screening.5
The CERTAIN (CERvical Tissue AdjunctIve aNalysis) study is one of the largest, most rigorous immunochemistry clinical studies done to date.
The CERTAIN Study included:
As a result of the CERTAIN Study, CINtec® Histology achieved ≥ 99% acceptability of for staining, morphology, and background. In addition, the CERTAIN study led to CAP (College of the American Pathologists), the ASCCP (American Society for Colposcopy and Cervical Pathology) and WHO (World Health Organization) recommending the adjunctive use of p16 IHC in evaluation of cervical biopsies. Learn more by accessing our training module on CINtec® Histology-CERTAIN Study
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. Access this article
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. Access this article
Killen 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. Access this article
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. Access this article
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. Access this article
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. Gynecologic Oncology 144 (2017) 51–56.Gynecol Oncol. 2017 Jan;144(1):51-56. doi: 10.1016/j.ygyno.2016.10.031. Access this article
Bergeron, C. et al., Prospective evaluation of p16/Ki-67 dual-stained cytology for managing women with abnormalPapanicolaou cytology: PALMS study results. Cancer Cytopathol. 2015 Jun;123(6):373-81. doi: 10.1002/cncy.21542. Epub 2015 Apr 17. Access this article
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. Access this article
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. Access this article
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. Access this article
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. Access this article
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 Access this article
Galgano, M, et al, Using Biomarkers as Objective Standards in the Diagnosis of Cervical Biopsies. Am J Surg Pathol. 2010;34:1077–1087. Access this article
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 Access this article