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A new paradigm in the fight against cervical cancer

HPV primary screening with the cobas® HPV Test identifies more high grade disease than a Pap test alone and maintains screening efficiency

Leading US medical societies (ACOG, ASCCP, SGO)* now recommend HPV primary screening as an option for cervical cancer screening women ages 25 and older.

Dr. Lee Shulman on HPV Primary Screening (Professor in Ob/Gyn at Feinberg School of Medicine, Northwestern University, Chicago):

HPV Primary Screening Algorithm

Primary Screening Algorithm

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.


Confidence in HPV DNA Testing

Safety of HPV Test

3-year cumulative incidence rate (CIR) of ≥CIN3 of Pap negative vs HPV DNA negative

ATHENA_negative-hpv-test.png

A negative cobas® HPV Test provides more 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.

Identify Those at Highest Risk

3-year cumulative incidence rate (CIR) of ≥CIN3 by high-risk HPV status

hpv-genotyping-appropriate-management.png

HPV 16 and 18 genotyping allows women to be stratified into distinct groups and managed according to risk

  • 1 in 4 women ages 25 and older testing HPV 16+ were diagnosed with ≥CIN3 over a 3 year follow-up period
  • Nearly 1 in 9 women ages 25 and older testing HPV 18+ were diagnosed with ≥CIN3 over 3 year follow-up period which is nearly twice the risk of the 12 other hrHPV genotypes combined

HPV Primary Screening Starting at Age 25

≥CIN3 by age group

ATHENA_CIN3_disease-in-women.png

28% 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

ATHENA_cytology.png

Cytology missed >57% of ≥CIN3 in 
women ages 25-29 confirming the poor performance of cytology alone in younger women

  • ATHENA data confirms that high-risk HPV testing with HPV 16 and 18 genotyping is superior to cytology alone for first-line primary screening of cervical cancer in both negative predictive value and detecting cervical disease
  • The concern regarding potential over-management of HPV positive women younger than 30 years of age can be addressed by using the HPV primary screening algorithm with the cobas® HPV Test

New strategies are needed to deliver improved patient care.

The case for HPV primary screening

Evidence supports hrHPV testing for primary screening of cervical cancer.4

  • The discovery of HPV as the cause of cervical cancer has the potential to revolutionize cervical cancer prevention strategies.1,4,5
  • In primary screening, hrHPV testing was proven more sensitive than cytology for detecting ≥CIN2 and ≥CIN3.6
  • 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.7
  • There is an opportunity to identify those at highest risk since 70% of cervical cancers are caused by HPV genotypes 16 and 18.1

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.


  • Acronyms:

References:

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.