This algorithm leverages the high sensitivity of HPV DNA, the built-in risk stratification of HPV 16/18 genotyping and triage with the high specificity of cytology for an optimal balance in cervical cancer screening.
3-year cumulative incidence rate (CIR) of ≥CIN3 of Pap negative vs HPV DNA negative
A negative cobas® HPV Test provides more than twice the confidence that ≥CIN3 will not develop within 3 years vs cytology alone
The ATHENA study, the largest US prospective registrational clinical study of its kind, evaluated the performance of the HPV Primary Screening Algorithm with the cobas ® HPV Test in women ages 25 and older
3-year cumulative incidence rate (CIR) of ≥CIN3 by high-risk HPV status
HPV 16 and 18 genotyping allows women to be stratified into distinct groups and managed according to risk
≥CIN3 by age group
More than 1/3 of ≥CIN3 disease was found in women 25-29 years old
ATHENA data indicates that screening women starting at 25 years with the cobas® HPV Test will help reduce the incidence of high-grade cervical disease
Proportion of women with normal cytology (NILM) diagnosed with ≥CIN3 by age group
Cytology missed >57% of ≥CIN3 in
women ages 25-29 confirming the poor performance of cytology alone in younger women
Evidence supports hrHPV testing for primary screening of cervical cancer.4
The cobas® HPV Test offers an opportunity to meet both goals of screening—it provides pooled hrHPV results on the known 12 “high-risk” genotypes and individual results on the highest-risk genotypes HPV 16 and 18, identifying women with the highest likelihood of harboring high-grade disease, while following a triage strategy that protects women from unnecessary intervention.2
See ATHENA HPV trial data on the use of the cobas® HPV Test as a primary screen.
1. 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.
2. 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.
3. Herzog TJ, Monk BH. Reducing the burden of glandular carcinomas of the uterine cervix. Am J Obstet Gynecol. 2007;197:566-571.
4. 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.
5. 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.
6. 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.
7. 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.