• roche logo

 

The devil is in the details.

Get the facts. Know her risk.

ATHENA trial results in the NILM population

≥CIN2

Absolute risk of ≥CIN2 stratified by hrHPV status in the ATHENA NILM population3

Absolute Risk of ≥CIN2 Stratified by hrHPV Status in the ATHENA NILM Population

Uncover disease missed by cytology.

  • ACOG states that HPV DNA tests specific for HPV types 16 and 18 can be used as an adjunct in women with negative Pap test results, but who have tested positive for hrHPV by an assay testing for 13 or 14 high-risk types.1
  • Moreover, new professional guidelines from the ASCCP, ASCP, and ACS suggest that women with normal cytology who are HPV 16+ or HPV 18+ be considered for immediate colposcopy.2
  • The cobas® HPV Test helps you adhere to the guidelines because it tells you who, among the HPV positive group is HPV 16 or HPV 18 positive, identifying those women at highest risk who may have been missed by cytology.

 

Conclusion: Nearly 1 in 7 women with normal cytology who were HPV 16+ were shown to have CIN2+ that was missed by cytology.4

Request copies of the clinical research manuscripts.

≥CIN3

Absolute risk of ≥CIN3 stratified by hrHPV status in the ATHENA NILM population3

Absolute risk of ≥CIN3 stratified by hrHPV status in the ATHENA NILM population3

Uncover disease missed by cytology.

  • ACOG states that HPV DNA tests specific for HPV types 16 and 18 can be used as an adjunct in women with negative Pap test results, but who have tested positive for hrHPV by an assay testing for 13 or 14 high-risk types.1
  • Moreover, the new professional guidelines from ASCCP, ASCP, and ACS suggest that women with normal cytology who are HPV 16+ or HPV 18+ be considered for immediate colposcopy.2
  • The cobas® HPV Test helps you adhere to the guidelines because it tells you who, among the HPV positive group is HPV 16 or HPV 18 positive, identifying those women at highest risk who may not have been identified by cytology.

 
Conclusion: Nearly 1 in 8 women with normal cytology who were HPV 16+ were shown to have CIN3+ that was missed by cytology.4

≥CIN3 missed by cytology

The cobas® HPV Test identifies ≥CIN3 in women with normal cytology.5,6

Uncover disease missed by cytology

Conclusion: Almost all of the cases of ≥CIN3 missed by cytology were identified by the cobas® HPV Test.4

 

 

Absolute risk of ≥CIN3 by screening strategies assessed in ATHENA at baseline

Absolute Risk of ≥CIN3 by Screening Strategies Assessed in ATHENA at Baseline

  • The ASCCP suggests that women with normal cytology who are HPV 16+ or HPV 18+ be considered for immediate colposcopy.7
  • The cobas® HPV Test helps you adhere to the guidelines by identifying those women at highest risk who were not identified by cytology.
 
 
 
 

 


Conclusion:
 Women with normal cytology who are positive for HPV 16 and/or HPV 18, and women with ASC-US who are pooled hrHPV positive share a high and immediate risk of cervical precancer.3,8


Clinical implications for the cobas® HPV Test from ATHENA in women with normal cytology

  • Women who are HPV 16 positive with normal cytology had a 13.6% absolute risk of ≥CIN2; therefore, nearly 1 in 7 women who tested positive for HPV 16 had high-grade cervical disease that was missed by cytology.3
  • Women who are HPV 16 positive are at the highest risk of cancer.3
  • The cobas® HPV Test supports a safely extended screening interval for women with normal cytology who are HPV negative, similar to other hrHPV DNA tests. 
  • The cobas® HPV Test allows a reduction in the screening burden on physicians and their patients.

  • Acronyms:

References:

1. The American Congress of Obstetricians and Gynecologists. ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists: Screening for Cervical Cancer. November, 2012

2. Saslow D et al, Journal of Lower Genital Tract Disease, Volume 16, Number 3, 2012

3. 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.

4. cobas
® 4800 HPV Test US package insert. April 2016.

5. Huh W, et al. 27th International Papillomavirus Conference, Berlin, Germany. Sept 17-22, 2011, OP-229.

6. 
Roche data on file. 2011.

7. 
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

8. 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.