Molecular.roche.com
For Patients
For Labs
Screening Portfolio
Contact
  • roche logo
CERVICAL CANCER SCREENING
COBAS® HPV TEST
ATHENA HPV CLINICAL TRIAL
CLINICAL GUIDELINES
HPV NEWS & RESOURCES
Molecular.roche.com
For Patients
For Labs
Screening Portfolio
Contact

The potential to set the new standard of care in cervical cancer screening.

The landmark ATHENA clinical study helped shape our understanding of the role of high-risk HPV testing in cervical cancer screening

  • Discover the ATHENA Study Design
  • Explore Key Features of the ATHENA Study
  • Review the ATHENA Study Results

 

ATHENA trial results in the ASC-US population

≥CIN2

Absolute risk of ≥CIN2 stratified by hrHPV status in the ATHENA ASC-US population2

Absolute Risk of ≥CIN2 Stratified by hrHPV Status in the ATHENA ASC-US Population

The cobas® HPV Test identifies women with highest risk of cervical cancer.

  • The ASCCP supports referral for colposcopy for women with ASC-US who are hrHPV positive.1
  • The cobas® HPV Test helps you follow the guidelines by providing pooled hrHPV results.
  • The cobas® HPV test also provides individual HPV 16 results to help you identify those women at highest risk who may need more intensive post colposcopic follow-up.

 
 
Conclusion: Individual detection of HPV 16 in women with ASC-US cytology identifies those women who are at the highest risk of cervical precancer.2
 

Request copies of the clinical research manuscripts.

≥CIN3

Absolute risk of ≥CIN3 stratified by hrHPV status in the ATHENA ASC-US population2

Absolute Risk of ≥CIN3 by hrHPV Status in the ATHENA ASC-US Population

The cobas® HPV Test identifies women with highest risk of cancer.

  • The ASCCP supports referral for colposcopy for women with ASC-US who are hrHPV positive.1
  • The cobas® HPV Test helps you follow the guidelines by providing pooled hrHPV results.
  • The cobas® HPV test also provides individual HPV 16 results to help you identify those women at highest risk who may need more intensive post colposcopic follow-up.

 

 

Conclusion: Individual detection of HPV 16 in women with ASC-US cytology identifies those women who are at the highest risk of cervical precancer.2

Uses of ASC-US triage

Stratification of ASC-US with the cobas® HPV Test identifies women who are hrHPV positive or HPV 16 positive separately.2

Stratification of ASC-US with the cobas® HPV Test

Conclusion: Women with ASC-US cytology who are HPV 16+ could benefit from intensive follow-up in the case of an unsatisfactory colposcopy result.2

Validation of the cobas® HPV Test

cobas® HPV Test and Hybrid Capture 2 (hc2)* in the ASC-US population for detection of ≥CIN23

The performance of the cobas® HPV Test is comparable to that of the prior standard of testing for pooled high-risk HPV, while adding the benefit of providing genotyping results for the highest-risk genotypes, HPV 16 and 18.

 

 

 

*hc2 and Hybrid Capture 2 is a trademark of Qiagen.

 

 

 

Scroll Right
Result (%) cobas® HPV Test hc2 Test
  Point estimate (95% CI) Point estimate (95% CI)
Sensitivity 90.0 (72/80) (82,95) 87.2 (68/78) (78,93)
Specificity 70.5 (1,056/1,498) (68,73) 71.1 (1,056/1,485) (69,73)
PPV 14.0 (72/514) (13,15) 13.7(68/497) (12,15)
NPV 99.2 (1,056/1,064) (98.6,99.6) 99.1 (1,056/1,066) (99.9,99.5)

PPV = positive predictive value; NPV = negative predictive value

Clinical implications for the cobas® HPV Test from ATHENA in the ASC-US population

  • Comparable performance to the prior standard of testing in pooled hrHPV testing
  • Significantly improves upon other commercially available HPV tests by individually identifying HPV 16 and 18 while simultaneously detecting 12 other hrHPV genotypes as a pooled result
  • The absolute risk of ≥CIN2 was 31.5% among women who were HPV 16 positive2
  • Pooled hrHPV negative women were at low risk of ≥CIN22
  • Women who were HPV 16 positive were more than twice as likely to have ≥CIN2 than those women who were pooled hrHPV positive2
 

Hear more from the experts on the implications of the ATHENA HPV trial.

  • Acronyms:

References:

1. American Society for Colposcopy and Cervical Pathology. HPV genotyping clinical update. http://www.asccp.org/Portals/9/docs/pdfs/Consensus%20Guidelines/clinical_update_20090408.pdf. Accessed August 9, 2011.

2. Stoler MH, Wright TC, Sharma A, et al. High-risk human papillomavirus testing in women with ASC-US cytology: results from the ATHENA HPV study. Am J Clin Pathol. 2011;135(3):468-475.

3. cobas® 4800 HPV Test US package insert. April 2011.

4. Wright TC Jr, Stoler MH, Sharma A, Zhang G, Behrens CM, Wright TL. 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.
09/05/2019

This website contains information on products which is targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. Please be aware that we do not take any responsibility for accessing such information which may not comply with any valid legal process, regulation, registration or usage in the country of your origin.