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CERVICAL CANCER SCREENING
COBAS® HPV TEST
ATHENA HPV CLINICAL TRIAL
CLINICAL GUIDELINES
HPV NEWS & RESOURCES
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For Labs
Screening Portfolio
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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.

 

 

 

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. www.asccp.org. 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.
03/25/2020

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