Article

Leaders in Cervical Cancer screening

An innovative solution for a real-world problem

The clinical evidence driving change

 

ATHENA (Addressing THE Need for Advanced HPV Diagnostics) is the largest U.S. prospective registrational clinical study of its kind, and was designed to evaluate performance of the cobas® HPV Test in different cervical cancer screening scenarios: HPV primary screening, ASC-US triage (ie, following a Pap test with abnormal findings) and co-testing (HPV and Pap cytology). The trial, enrolling more than 47,000 women, helped change our understanding of the importance of screening for high-risk HPV genotypes. Since HPV is the known cause of over 99% of all cervical cancers,2 finding women who are most at risk, before disease develops, is an important prevention strategy.

  • cobas® HPV was significantly more sensitive than Pap in detecting high-grade cervical disease (92.0% vs. 53.3%).1 3
  • Pap tests failed to identify high-grade cervical disease in approximately 1 in 7 women with HPV 164
  • A negative result with cobas® HPV provided reassurance that high-grade cervical disease would not develop within 3 years.3

 

The ATHENA study also supports the long-term safety of HPV DNA; results looking at baseline data and then again at a 3-years show a minimal loss in sensitivity for CIN3+ and CIN2+ detection. A negative HPV DNA result provides better confidence that CIN3+ will not develop within three years when compared to a negative Pap.

 

The Pap test, while successful at reducing the incidence and mortality of cervical cancer for many decades, has demonstrated limitations based on its subjectivity and often misses disease. Factors such as “Was the sample collected properly?” or “Were diseased cells not visually present during microscopic examination?” are often unknown, putting into question the accuracy of a negative finding.

Clinical guidelines evolving to catch up with advancement

 

More and more countries are adopting HPV DNA testing ahead of Pap cytology as part of their national cervical cancer screening programs. However, not all women who test positive for HPV will have or will develop cervical cancer. Therefore, some countries are updating their guidelines to also support use of triage tests based on p16 biomarker technology as a more effective way to assess if a positive HPV result is starting to undergo oncogenic transformation, or is progressing towards pre-cancer or cancer. Efficiently identifying women at risk, before pre-cancer or cancer develops, is an important prevention strategy as it helps maintain screening effectiveness and helps protect women from the potential harms of overtreatment.

 

SCREEN – MANAGE - DIAGNOSE

 

Roche has as unique portfolio of cervical cancer solutions that help clinicians better screen, manage and diagnose their patients, and provide confidence and certainty around care decisions.

When considering triage strategies for positive HPV DNA samples, CINtec® PLUS Cytology offers an important improvement over the decades old Pap test, CINtec® PLUS Cytology uses dual-biomarker technology to indicate cell cycle dysregulation. The simultaneous detection of p16 and Ki-67 is a strong indication that oncogenic(sp?) transformation is present.  This can help address with more certainty whether an HPV infection will resolve on its own, or requires more immediate intervention.

The medical value of triage with CINtec® PLUS Cytology vs. Pap cytology for HPV positive test results is further supported by comparison data from a retrospective study using a subset of samples collected in the ATHENA Trial. (Results are correlated to histology follow-up reported in the ATHENA data.)* Significantly more cervical disease was found by CINtec® PLUS Cytology vs Pap cytology, without a corresponding increase in the number of colposcopies performed.

p16 biomarker technology is also used by pathologists as a diagnostic tool with cervical biopsy samples. Roche’s CINtec® Histology immunochemistry test enhances identification of occult cervical lesions that may be missed by H&E or morphologic interpretation alone. CINtec® Histology provides visual confirmation of the presence or absence of high-grade cervical disease, and is the only clinically validated, FDA cleared p16 biomarker available.

 

cobas® HPV

Learn more about this industry changing assay, and deliver confidence with every result.

 

CINtec® PLUS Cytology Kit

Co-expression of p16 and Ki-67 in the same cell is strongly associated with established high-grade disease.

 

CINtec® Histology

CINtec® Histology finds 22.8% more high-grade disease. These women can now be treated appropriately.

 

For more information visit  HPV16and18.com.

Reated systems

 

cobas® 4800 System

Highly efficient, flexible workflows and a consolidated assay menu deliver confidence with every result. Automated PCR setup and analysis help make the most of your resources and reduce error.

More

 

cobas® 6800/8800 Systems

To further drive innovation forward, cobas® HPV for use on cobas® 6800/8800 Systems is now available.

More:

cobas® 6800 Systems

cobas® 8800 Systems

 

CINtec® PLUS Cytology

Advanced dual-biomarker technology that integrates with automated testing procedures to improve efficiency

The CINtec® PLUS Cytology test can be performed using either conventional or liquid-based samples, so users get more definitive information from the samples they already collect.

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CINtec® Histology  

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The cobas® HPV assays detect 14 high-risk HPV  with 12 high-risk HPV types as a pooled result, in one test and from one patient sample, and individual results for the two highest risk types, HPV 16 and HPV 18. cobas® HPV is the first and only FDA-approved, CE-mark test  for first-line primary cervical cancer screening

ATHENA Study design

Please click here to view the study design, enrollment, and follow-up phases of ATHENA

ATHENA Study

Please click here to learn more about key study features

ATHENA Study 3 year follow up

Review the results and 3-year follow-up data

References

 

* T.C. Wright Jr. et al., Triaging HPV-Positive Women with p16/Ki-67 Dual-stained Cytology: Results from a Sub-study Nested into the ATHENA Trial. Gynecologic Oncology 144 (2017) 51–56.

  1. Castle, PE, Stoler MH, Wright TC, 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. Lancet Oncol. 2011;12(9): 880-890.
  2. World Health Organization (WHO). Human papillomavirus (HPV). http://www.who.int/immunization/topics/hpv/en. Accessed on February 24, 2017.
  3. Wright TC Jr, et al. Primary cervical cancer screening with human papillomavirus: End of study results from the ATHENA study using HPV as the first-line screening test. Gynecol Oncol. 136 (2015) 189-197.
  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.