The first of its kind
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).
A key finding from ATHENA is that high-risk HPV testing is substantially more sensitive in detecting cervical disease than cytology (92.0% vs. 53.3%).1 The Pap test, while successful at reducing the incidence and mortality of cervical cancer the past 50+ years, has limitations based on its subjectivity and often misses disease.
By finding precancerous lesions early, clinicians can prevent cancer from developing. The cobas® HPV assays detect 14 high-risk HPV types that are responsible for over 99% of cervical cancers and report 12 high-risk HPV types as a pooled result, in one test and from one patient sample, as well as individual results for the two highest risk types, HPV 16 and HPV 18. These two types account for almost 70% of cases. Knowing if a woman is positive for HPV 16 or HPV 18 can help guide patient care and follow-up.
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.
More countries are adopting HPV DNA testing ahead of Pap cytology as part of their national cervical cancer screening programs. 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.
The landmark ATHENA study helped shape our understanding of the role of high-risk HPV testing in cervical cancer screening. HPV infections cause 99% of all cervical cancers,2 and the data show that current testing approaches offer room for improvement in identifying women who are most at risk for developing high-grade cervical disease.
The Pap test, a widely used method of cervical cancer screening for the past 70+ years, allows healthcare professionals to identify abnormal cells that may be indicative of cervical disease.
But a Pap test can be subjective to interpret and does not identify the presence of HPV, a more objective and sensitive indicator of a woman’s risk for cervical disease.
Clinically validated in the ATHENA trial, cobas® HPV detects 14 types of high-risk HPV (hrHPV), and provides specific genotyping information for HPV 16 and HPV 18 which are responsible for 70% of all cervical cancers.2 As the first and only FDA-approved and CE-marked assay for first-line primary cervical cancer screening, cobas® HPV demonstrates Roche’s commitment to doing now what patients need next.
Explore the ATHENA trial in detail
Addressing the Need for Advanced HPV Diagnostics
The landmark ATHENA trial was the largest-ever U.S.-based registrational study for cervical cancer screening, enrolling more than 47,000 women. The trial helped to change our understanding of the importance of screening for high-risk HPV genotypes.
- cobas® HPV was significantly more sensitive than Pap in detecting high-grade cervical disease3
- Pap tests failed to identify high-grade cervical disease in approximately 1 in 7 women with HPV 164
ATHENA helps to quantify the risk of pre-cancer and cervical cancer in women with HPV 16 and/or HPV 18. Conversely, a negative result with cobas® HPV provided reassurance that high-grade cervical disease would not develop within 3 years.3
Deliver confidence in every result
cobas® HPV enables clinicians to assess a woman’s risk of cervical disease with far greater confidence than was previously possible with existing testing options.3 For more information visit HPV16and18.com.
- 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.
- World Health Organization (WHO). Human papillomavirus (HPV). http://www.who.int/immunization/topics/hpv/en. Accessed on February 24, 2017.
- 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.
- 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..