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.